The clinical research industry is a dynamic one, filled with many moving parts, complex study designs, and equally complex agreements between project stakeholders. During the course of a clinical trial, adaptability and preparedness are critical for staying on course. Even in the face of everchanging protocols, regulations, and budgets, the study must continue with minimal interruptions. This creates the need for well-thought-out processes and communication plans between all parties to ensure project continuity and overall success. Some best practices to successfully manage the clinical trial’s financial lifecycle include:
- Formal processes and arrangements that properly align and balance detail vs. speed
- At the very beginning of a project, it is critical to clearly identify parties from both the CRO and the Sponsor who have the authority to make changes to the study’s legal/financial/operational agreements. Often the Sponsor’s procurement group message can be inconsistent with their Operational Team’s message. Thus the need to define a clear chain of command.
- Email Approvals and Change Notification Forms (CNFs) that bind trial changes can be effective tools in ensuring the ongoing alignment between the CRO and Sponsor. Because these types of agreements can provide quicker solutions than formal Change Orders, they can be utilized to provide financial and operational coverage during the critical time period while formal Change Orders are developed, negotiated, and executed. Both parties must reach an agreement upon the language and detail requirements for these documents so they can avoid confusion, delays, and disagreements as the trial inevitably evolves.
- Formalized and frequent communication between the necessary parties
- Adopt recurring meetings that require key players from both the CRO and the Sponsor. Frequency is dependent upon the size and complexity of the study, but most should plan for meetings at least once per month.
Without adopting these tools and safeguards, you run the risk of study delays, contentious/protracted budget negotiations, and financial and regulatory audit risks. With proper planning and alignment on the study’s goals and expectations, Sponsors and CROs alike can help keep studies on track financially, while being adaptable to the many variables that inevitably arise during the course of a clinical trial.
Author:
Will Kiser, CPA
Chief Financial Officer - Linical