Clinical Trial Site Contracting: The Conservative, Progressive And Hybrid Models

By Peg Tierney, Senior Project Lead, DrugDev

For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality.

One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.

Legal departments that wrestle with the question of relinquishing control often find themselves overburdened with mounds of legal paperwork. Even with today’s technology, many lawyers still prefer to read hard copies of contracts and make notes in red pen.  Concerns and challenges in the process include managing litigation, ensuring compliance, understanding the regulatory landscape, managing vendor contracts and – the piece that brings all the company’s efforts at research and development to fruition – the Clinical Trial Agreement, or CTA.