The connection between sponsors and contract research organizations (CROs) is strengthening as outsourcing continues to be a clinical trial mainstay. Making the relationship as productive as possible means acknowledging the ongoing transition away from tactical projects and toward strategic partnerships, with both stakeholders having a vested interest. This transition is taking many forms, but generally involves complexities, such as shared decision making, delivery of broad cross-study solutions, performance assessments, and shared risk and reward structures. At the core is a desire to build a collaborative long-lasting partnership, which requires open and transparent communications, fostering a foundation of trust and commitment.
Building relationships to improve clinical trial operations requires embracing centralized monitoring and study quality metrics as standard practice, and more recently, CRO oversight. Together, they form a solid basis for continuous quality management, but of these elements, CRO oversight has been gaining particular attention as sponsors sharpen their focus on how a clinical trial is progressing. One of the areas in need of greater CRO oversight is study startup, a perpetual bottleneck that continues to be handled largely by spreadsheets, shared file drives, and unsecured email, making data gathering and the timely sharing of data difficult in today’s global market. As evidence that more study startup oversight is needed, it can take an estimated eight months to move from pre-visit through site initiation. For sponsors, improving oversight of this function means real-time visibility into study startup progress, affording greater confidence in the reports they receive from the CROs involved.
Because sponsors often have multiple studies running concurrently with multiple CROs, oversight is complicated, as each CRO has its own method for study startup and for transmitting information back to the sponsor. This can result in inconsistent and outdated data, making it difficult to benchmark the status of the various studies in the portfolio based on the performance of each CRO per therapeutic area and geographic area. By transitioning to a solution used by all CROs across the portfolio, oversight improves, and sponsors can build reliable institutional knowledge about CRO performance.
As sponsors turn their attention to their core competencies, and continue to outsource, it is hardly surprising that stakeholders need a pathway to quality achievement as they build strategic relationships. Simply handing off multi-million dollar studies to CROs without carefully crafted plans for communications and reporting operational data as the study unfolds is hardly a wise move, yet what kind of oversight is needed, and how much is too much?
The issue of CRO oversight by sponsors is raised in guidance put forth by the FDA on risk-based monitoring. If a sponsor delegates monitoring responsibility to a CRO, FDA regulations require the CRO to comply with them. Also, the sponsor retains responsibility for oversight of the work completed by the CRO(s) they select. The guidance spells out oversight as the sponsor’s periodic review of monitoring reports and performance or quality metrics, as well as documented communication between the sponsor and CRO regarding monitoring progress. Importantly, both parties are to establish processes to exchange this relevant information.
Aligning with this guidance, sponsors see the size, scope, and complexity of clinical trials and their associated costs as justification for a degree of oversight that is well defined, transparent, and includes real-time reporting of study status and milestones. This approach addresses the problems inherent in gathering information from multiple CRO systems, causing lack of transparency, hard to see performance trends in study startup and other issues resulting from data compiled differently in each system. Study startup oversight is complicated further by the fact that study startup is a process with numerous steps, namely country selection, pre-study visits, site selection and initiation, regulatory document submission, budget and contract negotiations, patient recruitment initiatives, and enrolling the first patient.
The challenge for overseeing these tasks is to find the right balance, rather than taking a heavy-handed approach whereby CROs feel they are being micromanaged. The goal is for the sponsor and CRO to operate as a team with shared risk and agreed upon structures and processes. This is known as a centralized governance model, and entails gathering input from CRO(s) so they are onboard with sponsor oversight, including the training needed for stakeholders to achieve the desired level of quality performance. Research indicates that sponsors and CROs want a clear understanding of expectations at the beginning of a relationship, and as they put together the centralized governance model, issues such as trust, commitment on both sides, good communication, openness and transparency and upfront planning need to be clearly defined.
With research showing major differences in perceptions between sponsors and CROs regarding job performance, it is not surprising that these differences exist in several areas of clinical trial operations. Study startup is one function widely recognized as needing improvement and starts with selecting CROs able to provide full visibility of study progress and milestones, which facilitates sponsor oversight.
For study startup, cloud-based purpose-built technology that enables secured sharing of real-time data is gaining ground among CROs. The application acts as a single repository for in-progress documents, and information is accessed through a dashboard with a single logon, showing visualizations of study status across sites.
With this solution in place, sponsors can begin the process of CRO oversight, starting with configuring country workflows in accordance with the sponsor’s quality standards. From this point forward, the CRO(s) can start selecting sites, and sending study-related documents, while keeping sponsors apprised of study startup status. There is real-time visibility into potential bottlenecks, allowing for prompt attention.
This cloud-based approach to oversight benefits sponsors and CROs alike. For sponsors, they can receive standard, consistent reporting across all CROs and gain institutional knowledge on CRO and site performance data for future reuse. Moreover, the rework and error rate would likely decline. CROs able to offer this type of efficiencies to sponsors would offer competitive advantage in a maturing CRO marketplace and establish greater trust with the sponsor. In addition, the CRO would be able to reallocate resources to other value add tasks.
Oversight of CROs by sponsors is here to stay, but in the spirit of collaboration, oversight is most effective as a partnership in which both parties’ benefit. The goal of the partnership is to enable greater transparency and visibility into trial data. The intelligence gathered from the data can improve study startup by helping clinical project managers identify bottlenecks and take corrective action faster.
As clinical trials include sites from across the globe, cloud-based purpose-built solutions for study startup are bringing significant change by putting CROs and sponsors on equal footing. Research bears out this notion, with both sponsors and CROs acknowledging that use of new technology can facilitate adoption of intelligent methods of clinical development. Going forward, this approach can help clinical trial stakeholders realize the full potential of outsourcing arrangements.
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