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With the coming into law of the 2001 European Clinical Trials Directive in May of this year, this article looks at the Directive's effect on clinical trial outsourcing contracts and other key factors that shape and influence these agreements.
Clinical trials represent a key stage in the development of a compound, as well as, in many cases, the development of the sponsoring company. Successes in the clinic at an early stage can open doors for both partners and finance; failure can mean the end of not just a product, but potentially an entire business.
The entities involved in a trial have different roles and often competing interests in a study. The sponsor company or organisation has overall responsibility for the trial and will be seeking to test its compound in the minimum amount of time and for the minimum cost, whilst maintaining the integrity of the study data. Due to the nature of trials, sponsors will usually outsource the running of trials to 'trial sites', which are typically hospitals or academic institutions. Trial sites themselves will have one person who is in charge of running the trial at the site, known as the 'site investigator'. |
