In recent years, pharmaceutical companies have relied more and more on outsourcing clinical research in order to accomplish their goals.
In an interview with Applied Clinical Trials, Eurona E. Tilley, Managing Editor at PharmSource, explained that outsourcing not only provides a means for cheaper clinical trials in emerging markets, it also grants companies access to treatment-naïve patients, allowing for easier and faster patient recruitment.
“Patient enrollment is often easier in emerging markets and the population of treatment-naïve patients is greater, Tilley said. “This allows companies to save time, which ultimately translates into cost savings while enrolling patients and getting the study off the ground.”
As clinical trials costs are lower when conducted in other countries, CROs are able to conduct early trials with minimized risk.
And, as is often the case, understanding the local environment is key. Therefore forming an outsourcing partnership makes the clinical trials process smoother as the outsourcing company has a much better understanding of the local laws and regulations.
“CROs with operations in an emerging market are expected to have a better understanding of the regulatory landscape, cultural differences, and any country-specific hurdles that would arise while conducting a clinical trial in the country,” Tilley explained.
Although there are many benefits to outsourcing, with this new trend comes new challenges such as learning how to manage a team abroad and understanding the culture where the trial is being conducted. Tilley explored these issues among others during yesterday’s session, “Best Practices for How to Manage Your Global Teams and Retain Value While Outsourcing.”
The session outlined how to improve an outsourcing relationship, whether for a CRO or a small, midsized, or large biopharmaceutical company. Tilley moderated the session that included panelists from both CROs and pharmaceutical companies. Austen Eddy, Director of Clinical Operations, AVI BioPharma, and Devon Parmar, MD, Vice President Clinical Research, Wockhardt, represented the biopharmaceutical view, while David C. Hufner, Clinical Program Director, United BioSource Corporation, gave the CRO perspective.
The session also highlighted risk management strategies for navigating a pipeline through an outsourced relationship in an emerging market; and, an action plan for overcoming pitfalls that arise as a result of cultural differences, language barriers, and varying country-specific regulatory requirements.
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