PAUL RANSON
Fasken Martineau LLP, 17 Hanover Square London, W1S 1HU, United Kingdom

Abstract

The outsourcing of clinical research is a practice engaged in by most pharmaceutical and biotechnogy companies. Given the substantial sums involved and the financial, regulatory and health risks inherent in such relationships the contractual framework for such agreements has become increasingly complicated. In this article we review the general legal issues in outsourcing trials and related services and the specific provisions one should cover including regulatory compliance, intellectual property and confidentiality issues, dealings with trial sites, liability and indemnity matters, early termination, competitive recruitment and rights and obligations on termination.

INTRODUCTION

“Contract research” is a term that covers a multiplicity of tasks and levels of service. For instance, it may denote simply a single, discrete function, such as data analysis.
This paper addresses the following issues:

• General legal considerations in any outsourcing arrangement;
• Preparation and contractual structure
• Outsourcing in Clinical Drug Development
• Pre-contractual documentation, including confidentiality agreements and letters of intent;
• Clauses commonly found in a contract research agreement;
• Managing change; and
• Employment issues.

HOW A GOOD CONTRACT HELPS
Outsourcing is, in many ways, an extraordinary commercial arrangement. It puts the control of a sponsor’s commercial destiny in the hands of a complete outsider – the clinical research organisation (CRO). However the law recognizes no special relationship with or obligation of the CRO and hence legal protection for the sponsor arises only from what is built into the contract.
What if things go wrong or circumstances change? The sponsor ...