Bridging sponsors and sites: The changing role of the CRA

With a focus on prioritizing patient and investigator needs, the traditional sponsor-CRO relationship is evolving to include sites as part of the partnership matrix. This, combined with the increasing adoption of Functional Service Provider (FSP) delivery models, has made determining the right balance of control and accountability for each party a critical factor in successful outsourcing partnerships.?

Outsourcing strategies are adapting to better support sponsors’ commitment to strengthening their relationships with investigators. However, depending on the type of outsourcing model, the possibility of overlap (too many contacts) or gaps (unclear accountability and oversight) should be carefully considered. In parallel, effective partnerships between the sponsor, site and CRO typically lead to improved enrollment, better patient compliance, and opportunities to improve operational productivity and efficiency.?

But what is the right allocation of responsibilities between CRO and sponsor? What are the critical aspects of a trial that a sponsor should maintain as part of their remit?

A shift in paradigm

The traditional model of clinical research outsourcing has long relied on Clinical Research Associates (CRAs) to manage both data review and site relationships. However, as clinical trials become increasingly complex, there's a growing need for specialized roles that can address specific aspects of trial management more effectively.

One area of interest that is rapidly growing is ownership of the investigator site relationship and the creation of a new site relationship manager (SRM) role. The SRM is quickly becoming a crucial player in the industry's push for more agile and resilient outsourcing strategies and is transforming the way companies interact with investigative sites.

This new position is the result of splitting the CRA role into two distinct functions: one focused on data review and the other on nurturing site relationships. The SRM serves as a direct point of contact for investigative sites, concentrating on clinical trial delivery and execution.? To implement the SRM role across different studies and CRO partners efficiently, many biopharma companies are turning to the Functional Service Provider (FSP) delivery model. This approach offers greater flexibility for sponsors, allowing them to maintain control and oversight while delegating specific functions to specialized teams.

Early success and positive feedback

The implementation of SRMs has been met with overwhelmingly positive feedback. Investigators appreciate the direct line of communication with sponsors, leading to notable improvements in key areas such as:

• Enrollment rates
• Protocol compliance
• Data quality

These early successes have been observed in large-scale operations, with SRMs managing thousands of active sites across multiple countries.

Career development opportunities

The introduction of the SRM role opens exciting new career paths for clinical research professionals. It provides an alternative route for senior CRAs looking to grow beyond traditional study management roles. The position demands strong leadership qualities and the ability to lead without formal authority, as SRMs essentially act as ambassadors for sponsor companies.

Cultural fit and alignment

One of the critical factors in the success of the SRM role is the cultural fit between the SRM and the organization. These professionals must align closely with the sponsor's goals and prioritize relationship-building. This alignment has been identified as a major contributor to the successful implementation of the SRM role across various organizations.

Enhancing clinical trial execution

The SRM is not only the direct contact for the sites but is also a member of the core study team. They provide a new perspective to study teams, contributing to overall improvements in study management across functions and ultimately, clinical trial execution and delivery. Their focused approach to site relationships allows for more efficient communication and problem-solving, potentially leading to faster and more effective trials.

Conclusion: A new era in clinical research outsourcing

As the biopharmaceutical industry continues to adapt to changing market pressures and increasing complexities, innovations like the SRM role demonstrate the importance of evolving operational models and outsourcing strategies. ?

By striking the right balance between control and delegation, these new approaches have the potential to significantly improve the efficiency and effectiveness of clinical trials, ultimately benefiting patients and advancing medical science.

At Parexel, we collaborate With Heart? to help speed your life-changing medicines to patients who need them. That means grounding ourselves in the patient perspective, elevating our impact through operational excellence, and delivering integrated solutions and expertise you need across any or all phases of clinical development. Whether an emerging biotech or a large biopharmaceutical company, our commitment to first-time quality makes achieving your unique objectives easier. We're always available for a conversation >