Contract Research and Development Organizations-Their History, Selection, and Utilization:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Cham
Springer International Publishing AG
2020
|
| Schlagworte: | |
| Beschreibung: | Description based on publisher supplied metadata and other sources |
| Beschreibung: | 1 Online-Ressource (515 pages) |
| ISBN: | 9783030430733 |
Internformat
MARC
| LEADER | 00000nmm a2200000zc 4500 | ||
|---|---|---|---|
| 001 | BV048223038 | ||
| 003 | DE-604 | ||
| 005 | 00000000000000.0 | ||
| 007 | cr|uuu---uuuuu | ||
| 008 | 220516s2020 |||| o||u| ||||||eng d | ||
| 020 | |a 9783030430733 |9 978-3-030-43073-3 | ||
| 035 | |a (ZDB-30-PQE)EBC6273753 | ||
| 035 | |a (ZDB-30-PAD)EBC6273753 | ||
| 035 | |a (ZDB-89-EBL)EBL6273753 | ||
| 035 | |a (OCoLC)1178712686 | ||
| 035 | |a (DE-599)BVBBV048223038 | ||
| 040 | |a DE-604 |b ger |e rda | ||
| 041 | 0 | |a eng | |
| 082 | 0 | |a 658.57 | |
| 100 | 1 | |a Gad, Shayne C. |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Contract Research and Development Organizations-Their History, Selection, and Utilization |
| 264 | 1 | |a Cham |b Springer International Publishing AG |c 2020 | |
| 264 | 4 | |c ©2020 | |
| 300 | |a 1 Online-Ressource (515 pages) | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 500 | |a Description based on publisher supplied metadata and other sources | ||
| 505 | 8 | |a Intro -- Preface -- Selected Regulatory and Toxicological Acronyms -- Contents -- Contributors -- 1: Introduction -- Consultants -- Defining the Project -- Development of the Study Record -- Research Plan -- General Considerations -- Standard Operating Procedures -- Regulatory Performance -- Data Recording -- Analysis of the Data -- Reporting of Results and Conclusions -- Types of Data -- Raw Data -- Other Types of Data -- Computerized Data Collection -- Statistical Data -- Results and Conclusions -- Development of Study Data -- Quality Characteristics -- Recording Raw Data -- General Requirements for Raw Data Recording -- Error Correction in Data Recording -- Formats for Recording Data -- Laboratory Notebooks -- Results -- Forms and Worksheets -- Automated Data Collection Systems (LIMS - Laboratory Information Management System) -- Computer-Generated Raw Data -- Electronic Signatures -- Spreadsheets -- Reporting the Data -- Distinguishing Essential from Negotiable Study Elements -- Designating the Study Monitor -- Shifting Paradigms -- References -- Additional Reading -- 2: The History of CROs: Including CRO Snapshots -- Introduction -- The Early Years -- Food Drug Research Laboratories -- Lakeside Laboratories -- Illinois Institute of Technology Research Institute -- Chemical Hygiene Fellowship (Bushy Run Research Center) -- Southern Research Institute -- Hazleton Laboratories -- SRI International -- Lovelace Biomedical -- Charles River -- The Middle Years -- Industrial Biotest -- Woodard Research -- Gulf South Research Institute -- Bio/Dynamics -- Litton Bionetics, Inc. -- International Research and Development Corporation -- Bio-Research Laboratories (Canada) -- Ricera -- Calvert Laboratories -- Experimental Pathology Laboratories -- MB Research Laboratories -- Pacific BioLabs -- Utah Biomedical Toxicology Laboratories -- Stillmeadow, Inc | |
| 505 | 8 | |a Toxicology Pathology Services, Inc. -- WIL Research -- Springborn Institute for Bioresearch -- Hazleton Munster -- Borriston Laboratories -- Argus Research Laboratories -- The Later Years -- Toxicology Research Laboratory at the University of Illinois at Chicago -- International Toxicology Research -- Smithers Avanza -- Sinclair Research -- Sierra Biomedical -- Northern Biomedical Research -- MPI Research -- Covance, Inc. -- Burleson Research Technologies, Inc. -- SNBL USA -- Experimur -- Wuxi -- Xenometrics -- CiToxLAB -- Acknowledgment of Contributors -- Trends and the Dark Side of the Story -- References -- 3: Pharmaceutical Development -- Safety -- Pharmaceutical Development -- Pharmacology -- Analytical -- Clinical -- Regulatory -- Putting It All Together -- References -- 4: Medical Device Development -- Biocompatibility -- Fundamentals of Biocompatibility Tests -- Clinical Testing -- Market Characteristics -- Changing Focus, Changing Oversight -- The Review Speed Problem -- References -- 5: Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators) -- Hole in the Virtual Model: General Contractor -- Determining Outsourcing Needs -- Establishing the Scope of the Project -- Selecting an Outsource Partner -- Protecting Intellectual Property -- Managing the Project -- References -- 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global -- China -- Beyond Chemistry to Toxicology -- Why NOT Use a Chinese CRO? The #1 Response -- Good Laboratory Practice -- India -- GLP in India -- Indian Preclinical Contract Research Organizations -- Animal Welfare and Institutional Review of Toxicology Study Protocols -- GLP Status in India -- CROs in India -- Scientific Manpower -- Online Capture of Data -- General Competence of Indian CROs -- Bioanalysis and Toxicokinetics | |
| 505 | 8 | |a In Vitro and Mechanistic Studies -- Experience with Large Molecules -- Communications -- Report Quality -- Cost-Effectiveness of Indian CROs -- How to Qualify CRO in India -- Summary -- References -- 7: Selection of CRDOs -- The Trend Toward Outsourcing -- Rapid Growth -- The Buying of R& -- D -- Sources of Information on CROs -- Identifying Competent Laboratories -- Published Lists -- Information Available at Meetings -- "Freedom of Information" Requests -- The Middle Tier -- Key Considerations in Selecting a Lab -- Site Visits of Prospective Contract Laboratories -- Cost -- Reputation -- Protection of Client Confidentiality -- Prior Experience -- Scheduling -- Special Capabilities -- The Contract -- The Study Protocol -- Other Terms -- Authorship -- Reports -- Inspections by the Sponsor -- References -- 8: Study Directors and PIs -- Prologue -- The Study Director -- Technical/Scientific -- Business/Administrative -- Compliance -- First and Foremost Are Communication and Relationship Building Skills -- Also of Optimal Importance Are Technical and Troubleshooting Skills -- Scientific Interpretation and Results Writing Skills -- Conclusion -- The Spin -- The Perspective -- Discussion Style or Format -- Other Perspectives -- Data Interpretation -- Identify Changes -- Determine Relationship to Test Article -- Other Considerations -- Qualifying Language: Suitable Terminology to Utilize -- Assess Biological Significance -- What Should the Experience Level, Training, or Background of Your Study Director Be? -- Be Cognizant of and Maximally Utilize the Abilities of the Study Director's Team and Colleagues -- The Principal Investigator Role and Its Relation to the Study Director -- Chapter Epilogue -- How to Be a Highly Effective Study Director -- References -- 9: The Inner CRO: Laws, Regulations, and Guidelines for Animal Care and Use in Research | |
| 505 | 8 | |a Introduction -- History and Background -- US Animal Laws and Regulations -- Animal Welfare Act (AWA) -- Office of Laboratory Animal Welfare (OLAW) -- State and Local Regulations -- International Laws and Regulations -- European Union (EU) Laws and Regulations -- International Regulations and Resources -- Institutional Animal Care and Use Committee Requirements and Function -- Euthanasia -- Organizations Associated with Laboratory Animal Care and Use -- Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) -- American Association for Laboratory Animal Science (AALAS) -- American College of Laboratory Animal Medicine (ACLAM) -- Other Associations and Alternative Organizations -- Agencies That Provide Regulations and Guidelines on Animal Testing -- Facilities - An Overview -- Proper Care and Use of Animals -- Training Personnel -- Occupational Health and Safety Program -- Husbandry -- Enrichment -- Veterinary Care -- Disaster Preparedness -- Domestic and International Terrorism -- References -- 10: The Inner Cro: Pathology - Necropsy and Gross Pathology -- Introduction and Basic Concepts -- The Necropsy Laboratory and Necropsy Tools -- Necropsy Setup -- Necropsy General Comments -- Necropsy Personnel and Responsibilities -- The Prenecropsy Meeting -- Necropsy Data Collection -- The Language of Pathology and Necropsy -- The Necropsy Procedure -- Tissue Collection in Necropsy -- Weighing and Necropsy -- Missing Tissues -- Unscheduled Deaths -- Scheduled Deaths -- Tissue Fixation and Necropsy -- Blood and Bone Marrow Smears -- Special Considerations -- Whole-Animal or Whole-Organ Perfusion -- Photography -- Use of Image Data in Necropsy/Pathology -- Clinical Pathology -- References -- Other Readings -- 11: Electronic Reporting Requirements (SEND and eCTD) -- Introduction -- Where to Start | |
| 505 | 8 | |a Preparing the Nonclinical Section of the eCTD -- Format and Content -- Order of Presentation Within a Section (EMA 2003b) -- Module 4 Study Reports and Data -- Hints -- Submission of the eCTD -- Electronic Submissions Gateway -- Validation and Issues with Validation -- Acknowledgment -- Submission of SEND Data in Module 4 of the eCTD -- SEND Background -- SEND Regulatory -- SEND Features -- SEND Study Submission Package -- Determination of Studies that Need Data to Be Submitted as SEND Files -- FDA Center -- Type of Application -- Study Start Date -- Study Type -- SEND Responsibilities -- Conformance Validation -- Storage of Files at the FDA -- Wrapping Up -- References -- Note: all Internet links were last accessed in December 2019. -- Resources -- The FDA website has valuable information on the topics of eCTD and SEND. Note: all Internet links throughout this document, including the text and references, were last accessed in December 2019. -- 12: Study and Project Monitoring -- Scientific Integrity -- Technical/Operational Integrity -- Compliance -- Monitoring Strategies -- Interaction with the CRO Staff -- The Study Director -- The Technical Staff -- The Quality Assurance Staff -- The IACUC -- Information Technology -- Security -- Senior Leadership -- Subcontracted Services -- 13: Contracting, Pricing, and Cost of Works Performed by CROs -- Costing/Pricing -- The Contract -- Purpose and Description of Work -- Time Frame -- Regulatory and Judicial Proceedings -- Reports -- Innocent Mistakes and Culpable Tampering -- Communications -- Proprietary Rights -- Confidentiality -- Ethical and Legal Problems of Regulatory Disclosure -- 14: Consultants and Their Role -- Basics -- Types of Toxicology Consultants -- Necessary Attributes for a Consultant -- Scope Creep -- Topics for Discussion with Prospective Consultants for a Potential Project | |
| 505 | 8 | |a Bibliography | |
| 650 | 4 | |a (Produktform)Electronic book text | |
| 700 | 1 | |a Spainhour, Charles B. |e Sonstige |4 oth | |
| 700 | 1 | |a Serota, David G. |e Sonstige |4 oth | |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe |a Gad, Shayne C. |t Contract Research and Development Organizations-Their History, Selection, and Utilization |d Cham : Springer International Publishing AG,c2020 |z 9783030430726 |
| 912 | |a ZDB-30-PQE | ||
| 999 | |a oai:aleph.bib-bvb.de:BVB01-033603771 | ||
Datensatz im Suchindex
| _version_ | 1804184004806574080 |
|---|---|
| adam_txt | |
| any_adam_object | |
| any_adam_object_boolean | |
| author | Gad, Shayne C. |
| author_facet | Gad, Shayne C. |
| author_role | aut |
| author_sort | Gad, Shayne C. |
| author_variant | s c g sc scg |
| building | Verbundindex |
| bvnumber | BV048223038 |
| collection | ZDB-30-PQE |
| contents | Intro -- Preface -- Selected Regulatory and Toxicological Acronyms -- Contents -- Contributors -- 1: Introduction -- Consultants -- Defining the Project -- Development of the Study Record -- Research Plan -- General Considerations -- Standard Operating Procedures -- Regulatory Performance -- Data Recording -- Analysis of the Data -- Reporting of Results and Conclusions -- Types of Data -- Raw Data -- Other Types of Data -- Computerized Data Collection -- Statistical Data -- Results and Conclusions -- Development of Study Data -- Quality Characteristics -- Recording Raw Data -- General Requirements for Raw Data Recording -- Error Correction in Data Recording -- Formats for Recording Data -- Laboratory Notebooks -- Results -- Forms and Worksheets -- Automated Data Collection Systems (LIMS - Laboratory Information Management System) -- Computer-Generated Raw Data -- Electronic Signatures -- Spreadsheets -- Reporting the Data -- Distinguishing Essential from Negotiable Study Elements -- Designating the Study Monitor -- Shifting Paradigms -- References -- Additional Reading -- 2: The History of CROs: Including CRO Snapshots -- Introduction -- The Early Years -- Food Drug Research Laboratories -- Lakeside Laboratories -- Illinois Institute of Technology Research Institute -- Chemical Hygiene Fellowship (Bushy Run Research Center) -- Southern Research Institute -- Hazleton Laboratories -- SRI International -- Lovelace Biomedical -- Charles River -- The Middle Years -- Industrial Biotest -- Woodard Research -- Gulf South Research Institute -- Bio/Dynamics -- Litton Bionetics, Inc. -- International Research and Development Corporation -- Bio-Research Laboratories (Canada) -- Ricera -- Calvert Laboratories -- Experimental Pathology Laboratories -- MB Research Laboratories -- Pacific BioLabs -- Utah Biomedical Toxicology Laboratories -- Stillmeadow, Inc Toxicology Pathology Services, Inc. -- WIL Research -- Springborn Institute for Bioresearch -- Hazleton Munster -- Borriston Laboratories -- Argus Research Laboratories -- The Later Years -- Toxicology Research Laboratory at the University of Illinois at Chicago -- International Toxicology Research -- Smithers Avanza -- Sinclair Research -- Sierra Biomedical -- Northern Biomedical Research -- MPI Research -- Covance, Inc. -- Burleson Research Technologies, Inc. -- SNBL USA -- Experimur -- Wuxi -- Xenometrics -- CiToxLAB -- Acknowledgment of Contributors -- Trends and the Dark Side of the Story -- References -- 3: Pharmaceutical Development -- Safety -- Pharmaceutical Development -- Pharmacology -- Analytical -- Clinical -- Regulatory -- Putting It All Together -- References -- 4: Medical Device Development -- Biocompatibility -- Fundamentals of Biocompatibility Tests -- Clinical Testing -- Market Characteristics -- Changing Focus, Changing Oversight -- The Review Speed Problem -- References -- 5: Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators) -- Hole in the Virtual Model: General Contractor -- Determining Outsourcing Needs -- Establishing the Scope of the Project -- Selecting an Outsource Partner -- Protecting Intellectual Property -- Managing the Project -- References -- 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global -- China -- Beyond Chemistry to Toxicology -- Why NOT Use a Chinese CRO? The #1 Response -- Good Laboratory Practice -- India -- GLP in India -- Indian Preclinical Contract Research Organizations -- Animal Welfare and Institutional Review of Toxicology Study Protocols -- GLP Status in India -- CROs in India -- Scientific Manpower -- Online Capture of Data -- General Competence of Indian CROs -- Bioanalysis and Toxicokinetics In Vitro and Mechanistic Studies -- Experience with Large Molecules -- Communications -- Report Quality -- Cost-Effectiveness of Indian CROs -- How to Qualify CRO in India -- Summary -- References -- 7: Selection of CRDOs -- The Trend Toward Outsourcing -- Rapid Growth -- The Buying of R& -- D -- Sources of Information on CROs -- Identifying Competent Laboratories -- Published Lists -- Information Available at Meetings -- "Freedom of Information" Requests -- The Middle Tier -- Key Considerations in Selecting a Lab -- Site Visits of Prospective Contract Laboratories -- Cost -- Reputation -- Protection of Client Confidentiality -- Prior Experience -- Scheduling -- Special Capabilities -- The Contract -- The Study Protocol -- Other Terms -- Authorship -- Reports -- Inspections by the Sponsor -- References -- 8: Study Directors and PIs -- Prologue -- The Study Director -- Technical/Scientific -- Business/Administrative -- Compliance -- First and Foremost Are Communication and Relationship Building Skills -- Also of Optimal Importance Are Technical and Troubleshooting Skills -- Scientific Interpretation and Results Writing Skills -- Conclusion -- The Spin -- The Perspective -- Discussion Style or Format -- Other Perspectives -- Data Interpretation -- Identify Changes -- Determine Relationship to Test Article -- Other Considerations -- Qualifying Language: Suitable Terminology to Utilize -- Assess Biological Significance -- What Should the Experience Level, Training, or Background of Your Study Director Be? -- Be Cognizant of and Maximally Utilize the Abilities of the Study Director's Team and Colleagues -- The Principal Investigator Role and Its Relation to the Study Director -- Chapter Epilogue -- How to Be a Highly Effective Study Director -- References -- 9: The Inner CRO: Laws, Regulations, and Guidelines for Animal Care and Use in Research Introduction -- History and Background -- US Animal Laws and Regulations -- Animal Welfare Act (AWA) -- Office of Laboratory Animal Welfare (OLAW) -- State and Local Regulations -- International Laws and Regulations -- European Union (EU) Laws and Regulations -- International Regulations and Resources -- Institutional Animal Care and Use Committee Requirements and Function -- Euthanasia -- Organizations Associated with Laboratory Animal Care and Use -- Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) -- American Association for Laboratory Animal Science (AALAS) -- American College of Laboratory Animal Medicine (ACLAM) -- Other Associations and Alternative Organizations -- Agencies That Provide Regulations and Guidelines on Animal Testing -- Facilities - An Overview -- Proper Care and Use of Animals -- Training Personnel -- Occupational Health and Safety Program -- Husbandry -- Enrichment -- Veterinary Care -- Disaster Preparedness -- Domestic and International Terrorism -- References -- 10: The Inner Cro: Pathology - Necropsy and Gross Pathology -- Introduction and Basic Concepts -- The Necropsy Laboratory and Necropsy Tools -- Necropsy Setup -- Necropsy General Comments -- Necropsy Personnel and Responsibilities -- The Prenecropsy Meeting -- Necropsy Data Collection -- The Language of Pathology and Necropsy -- The Necropsy Procedure -- Tissue Collection in Necropsy -- Weighing and Necropsy -- Missing Tissues -- Unscheduled Deaths -- Scheduled Deaths -- Tissue Fixation and Necropsy -- Blood and Bone Marrow Smears -- Special Considerations -- Whole-Animal or Whole-Organ Perfusion -- Photography -- Use of Image Data in Necropsy/Pathology -- Clinical Pathology -- References -- Other Readings -- 11: Electronic Reporting Requirements (SEND and eCTD) -- Introduction -- Where to Start Preparing the Nonclinical Section of the eCTD -- Format and Content -- Order of Presentation Within a Section (EMA 2003b) -- Module 4 Study Reports and Data -- Hints -- Submission of the eCTD -- Electronic Submissions Gateway -- Validation and Issues with Validation -- Acknowledgment -- Submission of SEND Data in Module 4 of the eCTD -- SEND Background -- SEND Regulatory -- SEND Features -- SEND Study Submission Package -- Determination of Studies that Need Data to Be Submitted as SEND Files -- FDA Center -- Type of Application -- Study Start Date -- Study Type -- SEND Responsibilities -- Conformance Validation -- Storage of Files at the FDA -- Wrapping Up -- References -- Note: all Internet links were last accessed in December 2019. -- Resources -- The FDA website has valuable information on the topics of eCTD and SEND. Note: all Internet links throughout this document, including the text and references, were last accessed in December 2019. -- 12: Study and Project Monitoring -- Scientific Integrity -- Technical/Operational Integrity -- Compliance -- Monitoring Strategies -- Interaction with the CRO Staff -- The Study Director -- The Technical Staff -- The Quality Assurance Staff -- The IACUC -- Information Technology -- Security -- Senior Leadership -- Subcontracted Services -- 13: Contracting, Pricing, and Cost of Works Performed by CROs -- Costing/Pricing -- The Contract -- Purpose and Description of Work -- Time Frame -- Regulatory and Judicial Proceedings -- Reports -- Innocent Mistakes and Culpable Tampering -- Communications -- Proprietary Rights -- Confidentiality -- Ethical and Legal Problems of Regulatory Disclosure -- 14: Consultants and Their Role -- Basics -- Types of Toxicology Consultants -- Necessary Attributes for a Consultant -- Scope Creep -- Topics for Discussion with Prospective Consultants for a Potential Project Bibliography |
| ctrlnum | (ZDB-30-PQE)EBC6273753 (ZDB-30-PAD)EBC6273753 (ZDB-89-EBL)EBL6273753 (OCoLC)1178712686 (DE-599)BVBBV048223038 |
| dewey-full | 658.57 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 658 - General management |
| dewey-raw | 658.57 |
| dewey-search | 658.57 |
| dewey-sort | 3658.57 |
| dewey-tens | 650 - Management and auxiliary services |
| discipline | Wirtschaftswissenschaften |
| discipline_str_mv | Wirtschaftswissenschaften |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>11059nmm a2200445zc 4500</leader><controlfield tag="001">BV048223038</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">00000000000000.0</controlfield><controlfield tag="007">cr|uuu---uuuuu</controlfield><controlfield tag="008">220516s2020 |||| o||u| ||||||eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783030430733</subfield><subfield code="9">978-3-030-43073-3</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ZDB-30-PQE)EBC6273753</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ZDB-30-PAD)EBC6273753</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ZDB-89-EBL)EBL6273753</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)1178712686</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV048223038</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">658.57</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Gad, Shayne C.</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Contract Research and Development Organizations-Their History, Selection, and Utilization</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Cham</subfield><subfield code="b">Springer International Publishing AG</subfield><subfield code="c">2020</subfield></datafield><datafield tag="264" ind1=" " ind2="4"><subfield code="c">©2020</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource (515 pages)</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Description based on publisher supplied metadata and other sources</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Intro -- Preface -- Selected Regulatory and Toxicological Acronyms -- Contents -- Contributors -- 1: Introduction -- Consultants -- Defining the Project -- Development of the Study Record -- Research Plan -- General Considerations -- Standard Operating Procedures -- Regulatory Performance -- Data Recording -- Analysis of the Data -- Reporting of Results and Conclusions -- Types of Data -- Raw Data -- Other Types of Data -- Computerized Data Collection -- Statistical Data -- Results and Conclusions -- Development of Study Data -- Quality Characteristics -- Recording Raw Data -- General Requirements for Raw Data Recording -- Error Correction in Data Recording -- Formats for Recording Data -- Laboratory Notebooks -- Results -- Forms and Worksheets -- Automated Data Collection Systems (LIMS - Laboratory Information Management System) -- Computer-Generated Raw Data -- Electronic Signatures -- Spreadsheets -- Reporting the Data -- Distinguishing Essential from Negotiable Study Elements -- Designating the Study Monitor -- Shifting Paradigms -- References -- Additional Reading -- 2: The History of CROs: Including CRO Snapshots -- Introduction -- The Early Years -- Food Drug Research Laboratories -- Lakeside Laboratories -- Illinois Institute of Technology Research Institute -- Chemical Hygiene Fellowship (Bushy Run Research Center) -- Southern Research Institute -- Hazleton Laboratories -- SRI International -- Lovelace Biomedical -- Charles River -- The Middle Years -- Industrial Biotest -- Woodard Research -- Gulf South Research Institute -- Bio/Dynamics -- Litton Bionetics, Inc. -- International Research and Development Corporation -- Bio-Research Laboratories (Canada) -- Ricera -- Calvert Laboratories -- Experimental Pathology Laboratories -- MB Research Laboratories -- Pacific BioLabs -- Utah Biomedical Toxicology Laboratories -- Stillmeadow, Inc</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Toxicology Pathology Services, Inc. -- WIL Research -- Springborn Institute for Bioresearch -- Hazleton Munster -- Borriston Laboratories -- Argus Research Laboratories -- The Later Years -- Toxicology Research Laboratory at the University of Illinois at Chicago -- International Toxicology Research -- Smithers Avanza -- Sinclair Research -- Sierra Biomedical -- Northern Biomedical Research -- MPI Research -- Covance, Inc. -- Burleson Research Technologies, Inc. -- SNBL USA -- Experimur -- Wuxi -- Xenometrics -- CiToxLAB -- Acknowledgment of Contributors -- Trends and the Dark Side of the Story -- References -- 3: Pharmaceutical Development -- Safety -- Pharmaceutical Development -- Pharmacology -- Analytical -- Clinical -- Regulatory -- Putting It All Together -- References -- 4: Medical Device Development -- Biocompatibility -- Fundamentals of Biocompatibility Tests -- Clinical Testing -- Market Characteristics -- Changing Focus, Changing Oversight -- The Review Speed Problem -- References -- 5: Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators) -- Hole in the Virtual Model: General Contractor -- Determining Outsourcing Needs -- Establishing the Scope of the Project -- Selecting an Outsource Partner -- Protecting Intellectual Property -- Managing the Project -- References -- 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global -- China -- Beyond Chemistry to Toxicology -- Why NOT Use a Chinese CRO? The #1 Response -- Good Laboratory Practice -- India -- GLP in India -- Indian Preclinical Contract Research Organizations -- Animal Welfare and Institutional Review of Toxicology Study Protocols -- GLP Status in India -- CROs in India -- Scientific Manpower -- Online Capture of Data -- General Competence of Indian CROs -- Bioanalysis and Toxicokinetics</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">In Vitro and Mechanistic Studies -- Experience with Large Molecules -- Communications -- Report Quality -- Cost-Effectiveness of Indian CROs -- How to Qualify CRO in India -- Summary -- References -- 7: Selection of CRDOs -- The Trend Toward Outsourcing -- Rapid Growth -- The Buying of R&amp -- D -- Sources of Information on CROs -- Identifying Competent Laboratories -- Published Lists -- Information Available at Meetings -- "Freedom of Information" Requests -- The Middle Tier -- Key Considerations in Selecting a Lab -- Site Visits of Prospective Contract Laboratories -- Cost -- Reputation -- Protection of Client Confidentiality -- Prior Experience -- Scheduling -- Special Capabilities -- The Contract -- The Study Protocol -- Other Terms -- Authorship -- Reports -- Inspections by the Sponsor -- References -- 8: Study Directors and PIs -- Prologue -- The Study Director -- Technical/Scientific -- Business/Administrative -- Compliance -- First and Foremost Are Communication and Relationship Building Skills -- Also of Optimal Importance Are Technical and Troubleshooting Skills -- Scientific Interpretation and Results Writing Skills -- Conclusion -- The Spin -- The Perspective -- Discussion Style or Format -- Other Perspectives -- Data Interpretation -- Identify Changes -- Determine Relationship to Test Article -- Other Considerations -- Qualifying Language: Suitable Terminology to Utilize -- Assess Biological Significance -- What Should the Experience Level, Training, or Background of Your Study Director Be? -- Be Cognizant of and Maximally Utilize the Abilities of the Study Director's Team and Colleagues -- The Principal Investigator Role and Its Relation to the Study Director -- Chapter Epilogue -- How to Be a Highly Effective Study Director -- References -- 9: The Inner CRO: Laws, Regulations, and Guidelines for Animal Care and Use in Research</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Introduction -- History and Background -- US Animal Laws and Regulations -- Animal Welfare Act (AWA) -- Office of Laboratory Animal Welfare (OLAW) -- State and Local Regulations -- International Laws and Regulations -- European Union (EU) Laws and Regulations -- International Regulations and Resources -- Institutional Animal Care and Use Committee Requirements and Function -- Euthanasia -- Organizations Associated with Laboratory Animal Care and Use -- Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) -- American Association for Laboratory Animal Science (AALAS) -- American College of Laboratory Animal Medicine (ACLAM) -- Other Associations and Alternative Organizations -- Agencies That Provide Regulations and Guidelines on Animal Testing -- Facilities - An Overview -- Proper Care and Use of Animals -- Training Personnel -- Occupational Health and Safety Program -- Husbandry -- Enrichment -- Veterinary Care -- Disaster Preparedness -- Domestic and International Terrorism -- References -- 10: The Inner Cro: Pathology - Necropsy and Gross Pathology -- Introduction and Basic Concepts -- The Necropsy Laboratory and Necropsy Tools -- Necropsy Setup -- Necropsy General Comments -- Necropsy Personnel and Responsibilities -- The Prenecropsy Meeting -- Necropsy Data Collection -- The Language of Pathology and Necropsy -- The Necropsy Procedure -- Tissue Collection in Necropsy -- Weighing and Necropsy -- Missing Tissues -- Unscheduled Deaths -- Scheduled Deaths -- Tissue Fixation and Necropsy -- Blood and Bone Marrow Smears -- Special Considerations -- Whole-Animal or Whole-Organ Perfusion -- Photography -- Use of Image Data in Necropsy/Pathology -- Clinical Pathology -- References -- Other Readings -- 11: Electronic Reporting Requirements (SEND and eCTD) -- Introduction -- Where to Start</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Preparing the Nonclinical Section of the eCTD -- Format and Content -- Order of Presentation Within a Section (EMA 2003b) -- Module 4 Study Reports and Data -- Hints -- Submission of the eCTD -- Electronic Submissions Gateway -- Validation and Issues with Validation -- Acknowledgment -- Submission of SEND Data in Module 4 of the eCTD -- SEND Background -- SEND Regulatory -- SEND Features -- SEND Study Submission Package -- Determination of Studies that Need Data to Be Submitted as SEND Files -- FDA Center -- Type of Application -- Study Start Date -- Study Type -- SEND Responsibilities -- Conformance Validation -- Storage of Files at the FDA -- Wrapping Up -- References -- Note: all Internet links were last accessed in December 2019. -- Resources -- The FDA website has valuable information on the topics of eCTD and SEND. Note: all Internet links throughout this document, including the text and references, were last accessed in December 2019. -- 12: Study and Project Monitoring -- Scientific Integrity -- Technical/Operational Integrity -- Compliance -- Monitoring Strategies -- Interaction with the CRO Staff -- The Study Director -- The Technical Staff -- The Quality Assurance Staff -- The IACUC -- Information Technology -- Security -- Senior Leadership -- Subcontracted Services -- 13: Contracting, Pricing, and Cost of Works Performed by CROs -- Costing/Pricing -- The Contract -- Purpose and Description of Work -- Time Frame -- Regulatory and Judicial Proceedings -- Reports -- Innocent Mistakes and Culpable Tampering -- Communications -- Proprietary Rights -- Confidentiality -- Ethical and Legal Problems of Regulatory Disclosure -- 14: Consultants and Their Role -- Basics -- Types of Toxicology Consultants -- Necessary Attributes for a Consultant -- Scope Creep -- Topics for Discussion with Prospective Consultants for a Potential Project</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="a">Bibliography</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">(Produktform)Electronic book text</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Spainhour, Charles B.</subfield><subfield code="e">Sonstige</subfield><subfield code="4">oth</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Serota, David G.</subfield><subfield code="e">Sonstige</subfield><subfield code="4">oth</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe</subfield><subfield code="a">Gad, Shayne C.</subfield><subfield code="t">Contract Research and Development Organizations-Their History, Selection, and Utilization</subfield><subfield code="d">Cham : Springer International Publishing AG,c2020</subfield><subfield code="z">9783030430726</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-30-PQE</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-033603771</subfield></datafield></record></collection> |
| id | DE-604.BV048223038 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T19:50:37Z |
| indexdate | 2024-07-10T09:32:27Z |
| institution | BVB |
| isbn | 9783030430733 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033603771 |
| oclc_num | 1178712686 |
| open_access_boolean | |
| physical | 1 Online-Ressource (515 pages) |
| psigel | ZDB-30-PQE |
| publishDate | 2020 |
| publishDateSearch | 2020 |
| publishDateSort | 2020 |
| publisher | Springer International Publishing AG |
| record_format | marc |
| spelling | Gad, Shayne C. Verfasser aut Contract Research and Development Organizations-Their History, Selection, and Utilization Cham Springer International Publishing AG 2020 ©2020 1 Online-Ressource (515 pages) txt rdacontent c rdamedia cr rdacarrier Description based on publisher supplied metadata and other sources Intro -- Preface -- Selected Regulatory and Toxicological Acronyms -- Contents -- Contributors -- 1: Introduction -- Consultants -- Defining the Project -- Development of the Study Record -- Research Plan -- General Considerations -- Standard Operating Procedures -- Regulatory Performance -- Data Recording -- Analysis of the Data -- Reporting of Results and Conclusions -- Types of Data -- Raw Data -- Other Types of Data -- Computerized Data Collection -- Statistical Data -- Results and Conclusions -- Development of Study Data -- Quality Characteristics -- Recording Raw Data -- General Requirements for Raw Data Recording -- Error Correction in Data Recording -- Formats for Recording Data -- Laboratory Notebooks -- Results -- Forms and Worksheets -- Automated Data Collection Systems (LIMS - Laboratory Information Management System) -- Computer-Generated Raw Data -- Electronic Signatures -- Spreadsheets -- Reporting the Data -- Distinguishing Essential from Negotiable Study Elements -- Designating the Study Monitor -- Shifting Paradigms -- References -- Additional Reading -- 2: The History of CROs: Including CRO Snapshots -- Introduction -- The Early Years -- Food Drug Research Laboratories -- Lakeside Laboratories -- Illinois Institute of Technology Research Institute -- Chemical Hygiene Fellowship (Bushy Run Research Center) -- Southern Research Institute -- Hazleton Laboratories -- SRI International -- Lovelace Biomedical -- Charles River -- The Middle Years -- Industrial Biotest -- Woodard Research -- Gulf South Research Institute -- Bio/Dynamics -- Litton Bionetics, Inc. -- International Research and Development Corporation -- Bio-Research Laboratories (Canada) -- Ricera -- Calvert Laboratories -- Experimental Pathology Laboratories -- MB Research Laboratories -- Pacific BioLabs -- Utah Biomedical Toxicology Laboratories -- Stillmeadow, Inc Toxicology Pathology Services, Inc. -- WIL Research -- Springborn Institute for Bioresearch -- Hazleton Munster -- Borriston Laboratories -- Argus Research Laboratories -- The Later Years -- Toxicology Research Laboratory at the University of Illinois at Chicago -- International Toxicology Research -- Smithers Avanza -- Sinclair Research -- Sierra Biomedical -- Northern Biomedical Research -- MPI Research -- Covance, Inc. -- Burleson Research Technologies, Inc. -- SNBL USA -- Experimur -- Wuxi -- Xenometrics -- CiToxLAB -- Acknowledgment of Contributors -- Trends and the Dark Side of the Story -- References -- 3: Pharmaceutical Development -- Safety -- Pharmaceutical Development -- Pharmacology -- Analytical -- Clinical -- Regulatory -- Putting It All Together -- References -- 4: Medical Device Development -- Biocompatibility -- Fundamentals of Biocompatibility Tests -- Clinical Testing -- Market Characteristics -- Changing Focus, Changing Oversight -- The Review Speed Problem -- References -- 5: Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators) -- Hole in the Virtual Model: General Contractor -- Determining Outsourcing Needs -- Establishing the Scope of the Project -- Selecting an Outsource Partner -- Protecting Intellectual Property -- Managing the Project -- References -- 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global -- China -- Beyond Chemistry to Toxicology -- Why NOT Use a Chinese CRO? The #1 Response -- Good Laboratory Practice -- India -- GLP in India -- Indian Preclinical Contract Research Organizations -- Animal Welfare and Institutional Review of Toxicology Study Protocols -- GLP Status in India -- CROs in India -- Scientific Manpower -- Online Capture of Data -- General Competence of Indian CROs -- Bioanalysis and Toxicokinetics In Vitro and Mechanistic Studies -- Experience with Large Molecules -- Communications -- Report Quality -- Cost-Effectiveness of Indian CROs -- How to Qualify CRO in India -- Summary -- References -- 7: Selection of CRDOs -- The Trend Toward Outsourcing -- Rapid Growth -- The Buying of R& -- D -- Sources of Information on CROs -- Identifying Competent Laboratories -- Published Lists -- Information Available at Meetings -- "Freedom of Information" Requests -- The Middle Tier -- Key Considerations in Selecting a Lab -- Site Visits of Prospective Contract Laboratories -- Cost -- Reputation -- Protection of Client Confidentiality -- Prior Experience -- Scheduling -- Special Capabilities -- The Contract -- The Study Protocol -- Other Terms -- Authorship -- Reports -- Inspections by the Sponsor -- References -- 8: Study Directors and PIs -- Prologue -- The Study Director -- Technical/Scientific -- Business/Administrative -- Compliance -- First and Foremost Are Communication and Relationship Building Skills -- Also of Optimal Importance Are Technical and Troubleshooting Skills -- Scientific Interpretation and Results Writing Skills -- Conclusion -- The Spin -- The Perspective -- Discussion Style or Format -- Other Perspectives -- Data Interpretation -- Identify Changes -- Determine Relationship to Test Article -- Other Considerations -- Qualifying Language: Suitable Terminology to Utilize -- Assess Biological Significance -- What Should the Experience Level, Training, or Background of Your Study Director Be? -- Be Cognizant of and Maximally Utilize the Abilities of the Study Director's Team and Colleagues -- The Principal Investigator Role and Its Relation to the Study Director -- Chapter Epilogue -- How to Be a Highly Effective Study Director -- References -- 9: The Inner CRO: Laws, Regulations, and Guidelines for Animal Care and Use in Research Introduction -- History and Background -- US Animal Laws and Regulations -- Animal Welfare Act (AWA) -- Office of Laboratory Animal Welfare (OLAW) -- State and Local Regulations -- International Laws and Regulations -- European Union (EU) Laws and Regulations -- International Regulations and Resources -- Institutional Animal Care and Use Committee Requirements and Function -- Euthanasia -- Organizations Associated with Laboratory Animal Care and Use -- Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) -- American Association for Laboratory Animal Science (AALAS) -- American College of Laboratory Animal Medicine (ACLAM) -- Other Associations and Alternative Organizations -- Agencies That Provide Regulations and Guidelines on Animal Testing -- Facilities - An Overview -- Proper Care and Use of Animals -- Training Personnel -- Occupational Health and Safety Program -- Husbandry -- Enrichment -- Veterinary Care -- Disaster Preparedness -- Domestic and International Terrorism -- References -- 10: The Inner Cro: Pathology - Necropsy and Gross Pathology -- Introduction and Basic Concepts -- The Necropsy Laboratory and Necropsy Tools -- Necropsy Setup -- Necropsy General Comments -- Necropsy Personnel and Responsibilities -- The Prenecropsy Meeting -- Necropsy Data Collection -- The Language of Pathology and Necropsy -- The Necropsy Procedure -- Tissue Collection in Necropsy -- Weighing and Necropsy -- Missing Tissues -- Unscheduled Deaths -- Scheduled Deaths -- Tissue Fixation and Necropsy -- Blood and Bone Marrow Smears -- Special Considerations -- Whole-Animal or Whole-Organ Perfusion -- Photography -- Use of Image Data in Necropsy/Pathology -- Clinical Pathology -- References -- Other Readings -- 11: Electronic Reporting Requirements (SEND and eCTD) -- Introduction -- Where to Start Preparing the Nonclinical Section of the eCTD -- Format and Content -- Order of Presentation Within a Section (EMA 2003b) -- Module 4 Study Reports and Data -- Hints -- Submission of the eCTD -- Electronic Submissions Gateway -- Validation and Issues with Validation -- Acknowledgment -- Submission of SEND Data in Module 4 of the eCTD -- SEND Background -- SEND Regulatory -- SEND Features -- SEND Study Submission Package -- Determination of Studies that Need Data to Be Submitted as SEND Files -- FDA Center -- Type of Application -- Study Start Date -- Study Type -- SEND Responsibilities -- Conformance Validation -- Storage of Files at the FDA -- Wrapping Up -- References -- Note: all Internet links were last accessed in December 2019. -- Resources -- The FDA website has valuable information on the topics of eCTD and SEND. Note: all Internet links throughout this document, including the text and references, were last accessed in December 2019. -- 12: Study and Project Monitoring -- Scientific Integrity -- Technical/Operational Integrity -- Compliance -- Monitoring Strategies -- Interaction with the CRO Staff -- The Study Director -- The Technical Staff -- The Quality Assurance Staff -- The IACUC -- Information Technology -- Security -- Senior Leadership -- Subcontracted Services -- 13: Contracting, Pricing, and Cost of Works Performed by CROs -- Costing/Pricing -- The Contract -- Purpose and Description of Work -- Time Frame -- Regulatory and Judicial Proceedings -- Reports -- Innocent Mistakes and Culpable Tampering -- Communications -- Proprietary Rights -- Confidentiality -- Ethical and Legal Problems of Regulatory Disclosure -- 14: Consultants and Their Role -- Basics -- Types of Toxicology Consultants -- Necessary Attributes for a Consultant -- Scope Creep -- Topics for Discussion with Prospective Consultants for a Potential Project Bibliography (Produktform)Electronic book text Spainhour, Charles B. Sonstige oth Serota, David G. Sonstige oth Erscheint auch als Druck-Ausgabe Gad, Shayne C. Contract Research and Development Organizations-Their History, Selection, and Utilization Cham : Springer International Publishing AG,c2020 9783030430726 |
| spellingShingle | Gad, Shayne C. Contract Research and Development Organizations-Their History, Selection, and Utilization Intro -- Preface -- Selected Regulatory and Toxicological Acronyms -- Contents -- Contributors -- 1: Introduction -- Consultants -- Defining the Project -- Development of the Study Record -- Research Plan -- General Considerations -- Standard Operating Procedures -- Regulatory Performance -- Data Recording -- Analysis of the Data -- Reporting of Results and Conclusions -- Types of Data -- Raw Data -- Other Types of Data -- Computerized Data Collection -- Statistical Data -- Results and Conclusions -- Development of Study Data -- Quality Characteristics -- Recording Raw Data -- General Requirements for Raw Data Recording -- Error Correction in Data Recording -- Formats for Recording Data -- Laboratory Notebooks -- Results -- Forms and Worksheets -- Automated Data Collection Systems (LIMS - Laboratory Information Management System) -- Computer-Generated Raw Data -- Electronic Signatures -- Spreadsheets -- Reporting the Data -- Distinguishing Essential from Negotiable Study Elements -- Designating the Study Monitor -- Shifting Paradigms -- References -- Additional Reading -- 2: The History of CROs: Including CRO Snapshots -- Introduction -- The Early Years -- Food Drug Research Laboratories -- Lakeside Laboratories -- Illinois Institute of Technology Research Institute -- Chemical Hygiene Fellowship (Bushy Run Research Center) -- Southern Research Institute -- Hazleton Laboratories -- SRI International -- Lovelace Biomedical -- Charles River -- The Middle Years -- Industrial Biotest -- Woodard Research -- Gulf South Research Institute -- Bio/Dynamics -- Litton Bionetics, Inc. -- International Research and Development Corporation -- Bio-Research Laboratories (Canada) -- Ricera -- Calvert Laboratories -- Experimental Pathology Laboratories -- MB Research Laboratories -- Pacific BioLabs -- Utah Biomedical Toxicology Laboratories -- Stillmeadow, Inc Toxicology Pathology Services, Inc. -- WIL Research -- Springborn Institute for Bioresearch -- Hazleton Munster -- Borriston Laboratories -- Argus Research Laboratories -- The Later Years -- Toxicology Research Laboratory at the University of Illinois at Chicago -- International Toxicology Research -- Smithers Avanza -- Sinclair Research -- Sierra Biomedical -- Northern Biomedical Research -- MPI Research -- Covance, Inc. -- Burleson Research Technologies, Inc. -- SNBL USA -- Experimur -- Wuxi -- Xenometrics -- CiToxLAB -- Acknowledgment of Contributors -- Trends and the Dark Side of the Story -- References -- 3: Pharmaceutical Development -- Safety -- Pharmaceutical Development -- Pharmacology -- Analytical -- Clinical -- Regulatory -- Putting It All Together -- References -- 4: Medical Device Development -- Biocompatibility -- Fundamentals of Biocompatibility Tests -- Clinical Testing -- Market Characteristics -- Changing Focus, Changing Oversight -- The Review Speed Problem -- References -- 5: Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators) -- Hole in the Virtual Model: General Contractor -- Determining Outsourcing Needs -- Establishing the Scope of the Project -- Selecting an Outsource Partner -- Protecting Intellectual Property -- Managing the Project -- References -- 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global -- China -- Beyond Chemistry to Toxicology -- Why NOT Use a Chinese CRO? The #1 Response -- Good Laboratory Practice -- India -- GLP in India -- Indian Preclinical Contract Research Organizations -- Animal Welfare and Institutional Review of Toxicology Study Protocols -- GLP Status in India -- CROs in India -- Scientific Manpower -- Online Capture of Data -- General Competence of Indian CROs -- Bioanalysis and Toxicokinetics In Vitro and Mechanistic Studies -- Experience with Large Molecules -- Communications -- Report Quality -- Cost-Effectiveness of Indian CROs -- How to Qualify CRO in India -- Summary -- References -- 7: Selection of CRDOs -- The Trend Toward Outsourcing -- Rapid Growth -- The Buying of R& -- D -- Sources of Information on CROs -- Identifying Competent Laboratories -- Published Lists -- Information Available at Meetings -- "Freedom of Information" Requests -- The Middle Tier -- Key Considerations in Selecting a Lab -- Site Visits of Prospective Contract Laboratories -- Cost -- Reputation -- Protection of Client Confidentiality -- Prior Experience -- Scheduling -- Special Capabilities -- The Contract -- The Study Protocol -- Other Terms -- Authorship -- Reports -- Inspections by the Sponsor -- References -- 8: Study Directors and PIs -- Prologue -- The Study Director -- Technical/Scientific -- Business/Administrative -- Compliance -- First and Foremost Are Communication and Relationship Building Skills -- Also of Optimal Importance Are Technical and Troubleshooting Skills -- Scientific Interpretation and Results Writing Skills -- Conclusion -- The Spin -- The Perspective -- Discussion Style or Format -- Other Perspectives -- Data Interpretation -- Identify Changes -- Determine Relationship to Test Article -- Other Considerations -- Qualifying Language: Suitable Terminology to Utilize -- Assess Biological Significance -- What Should the Experience Level, Training, or Background of Your Study Director Be? -- Be Cognizant of and Maximally Utilize the Abilities of the Study Director's Team and Colleagues -- The Principal Investigator Role and Its Relation to the Study Director -- Chapter Epilogue -- How to Be a Highly Effective Study Director -- References -- 9: The Inner CRO: Laws, Regulations, and Guidelines for Animal Care and Use in Research Introduction -- History and Background -- US Animal Laws and Regulations -- Animal Welfare Act (AWA) -- Office of Laboratory Animal Welfare (OLAW) -- State and Local Regulations -- International Laws and Regulations -- European Union (EU) Laws and Regulations -- International Regulations and Resources -- Institutional Animal Care and Use Committee Requirements and Function -- Euthanasia -- Organizations Associated with Laboratory Animal Care and Use -- Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) -- American Association for Laboratory Animal Science (AALAS) -- American College of Laboratory Animal Medicine (ACLAM) -- Other Associations and Alternative Organizations -- Agencies That Provide Regulations and Guidelines on Animal Testing -- Facilities - An Overview -- Proper Care and Use of Animals -- Training Personnel -- Occupational Health and Safety Program -- Husbandry -- Enrichment -- Veterinary Care -- Disaster Preparedness -- Domestic and International Terrorism -- References -- 10: The Inner Cro: Pathology - Necropsy and Gross Pathology -- Introduction and Basic Concepts -- The Necropsy Laboratory and Necropsy Tools -- Necropsy Setup -- Necropsy General Comments -- Necropsy Personnel and Responsibilities -- The Prenecropsy Meeting -- Necropsy Data Collection -- The Language of Pathology and Necropsy -- The Necropsy Procedure -- Tissue Collection in Necropsy -- Weighing and Necropsy -- Missing Tissues -- Unscheduled Deaths -- Scheduled Deaths -- Tissue Fixation and Necropsy -- Blood and Bone Marrow Smears -- Special Considerations -- Whole-Animal or Whole-Organ Perfusion -- Photography -- Use of Image Data in Necropsy/Pathology -- Clinical Pathology -- References -- Other Readings -- 11: Electronic Reporting Requirements (SEND and eCTD) -- Introduction -- Where to Start Preparing the Nonclinical Section of the eCTD -- Format and Content -- Order of Presentation Within a Section (EMA 2003b) -- Module 4 Study Reports and Data -- Hints -- Submission of the eCTD -- Electronic Submissions Gateway -- Validation and Issues with Validation -- Acknowledgment -- Submission of SEND Data in Module 4 of the eCTD -- SEND Background -- SEND Regulatory -- SEND Features -- SEND Study Submission Package -- Determination of Studies that Need Data to Be Submitted as SEND Files -- FDA Center -- Type of Application -- Study Start Date -- Study Type -- SEND Responsibilities -- Conformance Validation -- Storage of Files at the FDA -- Wrapping Up -- References -- Note: all Internet links were last accessed in December 2019. -- Resources -- The FDA website has valuable information on the topics of eCTD and SEND. Note: all Internet links throughout this document, including the text and references, were last accessed in December 2019. -- 12: Study and Project Monitoring -- Scientific Integrity -- Technical/Operational Integrity -- Compliance -- Monitoring Strategies -- Interaction with the CRO Staff -- The Study Director -- The Technical Staff -- The Quality Assurance Staff -- The IACUC -- Information Technology -- Security -- Senior Leadership -- Subcontracted Services -- 13: Contracting, Pricing, and Cost of Works Performed by CROs -- Costing/Pricing -- The Contract -- Purpose and Description of Work -- Time Frame -- Regulatory and Judicial Proceedings -- Reports -- Innocent Mistakes and Culpable Tampering -- Communications -- Proprietary Rights -- Confidentiality -- Ethical and Legal Problems of Regulatory Disclosure -- 14: Consultants and Their Role -- Basics -- Types of Toxicology Consultants -- Necessary Attributes for a Consultant -- Scope Creep -- Topics for Discussion with Prospective Consultants for a Potential Project Bibliography (Produktform)Electronic book text |
| title | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_auth | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_exact_search | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_exact_search_txtP | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_full | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_fullStr | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_full_unstemmed | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_short | Contract Research and Development Organizations-Their History, Selection, and Utilization |
| title_sort | contract research and development organizations their history selection and utilization |
| topic | (Produktform)Electronic book text |
| topic_facet | (Produktform)Electronic book text |
| work_keys_str_mv | AT gadshaynec contractresearchanddevelopmentorganizationstheirhistoryselectionandutilization AT spainhourcharlesb contractresearchanddevelopmentorganizationstheirhistoryselectionandutilization AT serotadavidg contractresearchanddevelopmentorganizationstheirhistoryselectionandutilization |