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54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

07. bis 10.09.2009, Essen

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Outsourcing of Clinical Trials and Non-Interventional Studies – Selection of CRO from a Data Management, Biostatistics, Medical Writing and Quality Management Perspective

Meeting Abstract

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  • Stefan Schinzel - Sanofi-Aventis Deutschland GmbH, Frankfurt am Main
  • Karlheinz Theobald - Sanofi-Aventis Deutschland GmbH, Frankfurt am Main
  • Friedbert Theis - Sanofi-Aventis Deutschland GmbH, Frankfurt am Main
  • Ferdinand Hundt - Sanofi-Aventis Deutschland GmbH, Berlin
  • Marlis Herbold - Sanofi-Aventis Deutschland GmbH, Frankfurt am Main

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Essen, 07.-10.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gmds092

doi: 10.3205/09gmds092, urn:nbn:de:0183-09gmds0921

Published: September 2, 2009

© 2009 Schinzel et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

Nowadays outsourcing of clinical trial activities by pharmaceutical companies (PCO) to clinical research organizations (CRO) is a relevant quality topic in this multi-billion dollar business (2004 data as reported in [1]). The main reasons for outsourcing are

  • Lack of in-house resources
  • Head-count flexibility
  • Lack of know-how, e.g. in phases and/or indications beyond the recent focus of the PCO
  • Flexibility to change strategic orientation of the PCO.

Since clinical trials and/or non-interventional studies (NIS) represent major investments by PCO and the choice of the adequate CRO is a crucial success factor for the project it should be common practice to perform pre-contract audits at those CRO in question with which no cooperation is established yet [2], [3]. In general these audits are performed by experienced quality management (QM) employees of the PCO, who do not always have profound background in data management (DM), biostatistics/statistical programming (Bio) or medical writing (MW). Up to now these fields, which are in general only a part of the tasks to be subcontracted, were to some extent neglected in such audits. This talk focuses on aspects to be checked with regard to data management facilities, biostatistics and medical writing know-how of the CRO and may serve as a guide for pre-contract audit activities in these fields. The structure of this presentation reflects a checklist, which in part is depicted in the slides and may be obtained from the authors on request.

Outline

References

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Tufts Center for the Study of Drug Development. January/February 2006 Impact Report; study commissioned by the Association of Clinical Research Organizations (ACRO). 2006.
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Chase D, Schmidt JH; Audit 2000 III. Sponsor-Audits bei Contract Research Organisations (CRO) – Beschreibung aus der Sicht der CRO, Teil 1. Pharm Ind. 2000;62(9):662-5.
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Chase D, Schmidt JH; Audit 2000 III. Sponsor-Audits bei Contract Research Organisations (CRO) – Beschreibung aus der Sicht der CRO, Teil 2. Pharm Ind. 2000;62(10):744-50.
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Anonym. General Principles of Software Validation; Final Guidance for Industry and FDA Staff. 2002.
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Anonym. FDA, 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule. Federal Register. 1997;62(54):13429.