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[Industry Voice #11] Stayble Therapeutics…
Contract Research Organizations (CROs) are inextricable from the clinical research landscape. While they may have once been viewed as no more than vendors in the process of managing clinical trials, their role has evolved to be much more. Many Sponsors around the globe now hold long-term, strategic partnerships with one or more CROs.
Clinical trial outsourcing relationships can take many different forms. At their most basic, they are purely transactional. But simplicity in a Sponsor-CRO relationship does not necessarily lead to an outcome of efficiency.
How can Sponsors get more from their CRO partnerships? Here are a few insights from our 15+ years in clinical study management.
What to Know Before Offshoring Clinical Trials
Careful CRO selection is a prerequisite for a successful relationship. The RFP stage presents many opportunities to assess the CRO’s services and other potential benefits of working together. It is in the Sponsor’s best interest to be thorough in their evaluation — not only regarding the capabilities of the organization itself, but also of the individuals who will be involved in the project. What is their experience in clinical development? Do they hold expertise in specific therapeutic areas, or knowledge of complex regulatory environments? How well do they communicate?
Managing clinical trials requires communication, cooperation, and commitment. The more time the Sponsor and CRO invest in getting to know each other up front, the more productive they will be when it is time to begin work on a project.
Process Optimization in Clinical Study Management
Project management in clinical trials holds the key to operational success or failure. It is up to both parties to clarify roles and responsibilities, prevent duplication of efforts, and ensure that study protocols are carried out according to plan.
Working together, the Sponsor and CRO must establish processes and communication schedules that fit the unique needs of the project. Defining these approaches to project management for clinical trials will combat common hindrances to study success.
Ideal Business Outcomes of Partnering with Contract Research Organizations
While strategic partnerships take considerable time and effort to build, the end goal is simple: mutually advantageous business outcomes, compounded throughout the life of the relationship. When one party succeeds, so does the other. That happens naturally when parties take ownership of shared goals (and the risks that come with them).
As a CRO managing clinical trials in Russia for 15 years, the team at OCT Clinical has extensive experience navigating the complexities of the Sponsor-CRO relationship. By helping trials run efficiently in conjunction with Sponsors, we build strong, fruitful relationships that flourish with time.