Outsourcing contracts in biotech clinical trials administration

Clinical Trial Outsourcing

Contract Issues in the Outsourcing of Clinical Trials

The increasingly common practice of outsourcing clinical trials for pharmaceutical research and development is fraught with legal and ethical complications, especially as much of the outsourcing finds these clinical trials taking place in underdeveloped countries that lack infrastructure and appropriate civil and social oversight. In a scenario such as the one described, where an unequal partnership shares certain rights to the intellectual property and the physical substance that will be undergoing the clinical trial, new wrinkles in the responsibilities of parties and the necessities of established contracts arise. Looking to current research in the area can help determine the services and contract constraints that will be required to create an ethical and effective clinical trial that serves the immediate research and development needs of the pharmaceutical partnership hiring a central African company to conduct clinical trials.

The services that will be necessary to continue development of the pharmaceutical are an essential part of the trial outsourcing. A variety of medical and medical support services, from the recruitment of participants to initial examination to ongoing testing during the trial and many others, will be required as the fundamental operation of the trial (Rettig, 2000). There are also many accounting and legal services that will need to be procured, ensuring that the clinical trial meets with all relevant governmental criteria for United States/European standards and with the laws in place in the country selected for the trial, such that an entire industry of contract research has emerged (Sen & Shiel, 2006; Petryna, 2007; Rettig, 2000; Shuchman, 2007). These firms can ensure that all necessary services are adequately procured.

Clearly, contracting with a contract research organization to handle further contracting would be very beneficial is there is enough capital to cover the additional upfront expense (Rettig, 2000; Sen & Shiel, 2006; Shuchman, 2007). Specific organization types that will need to be contracted with for the actual conducting of the clinical trial include a variety of medical organizations for the provisions of the specific services identified above, including a hospital or other physical location with basic medical offices, laboratories for a variety of different testing before and during the trial, legal compliance and oversight parties to ensure objectivity and compliance of the actual processes of the trial, and more (Rettig, 2000; Sen & Shiel, 2006; Petryna, 2007; Shuchman, 2007). In addition, because there is uneven distribution of the rights to the intellectual and physical property of the substance undergoing the clinical trial, legal counsel for the development of a contract between the partners arranging for the clinical trial is also recommended.