Imagine this scenario: It’s Monday morning, you roll into your office, log on to your computer and waiting for you in the reminder window of your email in big letters. “Start preparing for governance meeting in two weeks. As a project manager, project/program director it can be challenging to add one more meeting to your already busy schedule, but… take a deep breath. Project Governance matters. Indeed at Linical, we treat project governance as an essential function the overall clinical trial.
Clinical trials are more complex and expensive than ever in the clinical research landscape today, with individualized treatments and decentralized models as examples. Effective governance between sponsors and Contract Research Organizations (CROs) such as Linical is no longer simply an optional exercise, it is a strategic necessity. With sponsors outsourcing trial execution activities to CROs, the success of clinical trials and overall programs hinges on strong, transparent, and well-structured communication models to ensure objectives are met, quality is upheld, and performance measured and driven. Without effective project governance, the risk increases of poor communication, misaligned expectations and cost overruns due to delays and/or rework.
A well-designed governance structure can and should include:
From a regulatory perspective, sponsors ultimately are responsible for the quality and compliance of a study, even if it is fully outsourced to Linical. The implementation of ICH-GCP R3 has made this even more explicit. A strong governance model will ensure that the sponsor can demonstrate to regulatory bodies such as the FDA and EMA that they are maintaining oversight of the study as well as ensuring compliance with ICH-GCP. From both a sponsor and a Linical point of view, governance will ensure that responsibilities are clearly defined and a pathway for issue escalation is clear.
Every clinical trial has its own unique set of risks. From a risk management perspective, strong governance will allow for timely identification of risks from the inception of the study and will allow for systematic classification and escalation. This will set the foundation for proactively managing issues that occur in the study rather than reactive, which often results in finger pointing and is counterproductive. From a risk management perspective, Linical begins the process at the proposal stage, identifying potential risks from a multifunctional approach and propose actions to mitigate. A risk that that identified from draft protocol synopsis may ultimately save both financial costs and just as important time cost over the course of the study..
From an execution standpoint, governance is critical. Linical and other CROs ultimately are measured on their efficiency from a timeline and financial standpoint as well as their overall deliverables. Governance ensures that performance can be measured, and any issues are identified early so that they may be remediated. Typically, any strong governance structure will include multifunctional KPIs and metrics to demonstrate performance as well as to provide opportunity to improve a process when the metrics are less than ideal. KPIs can run the full spectrum from ones that are standard (site activation timelines, Query Rate, etc.) to being very specific for the execution of the study. Of utmost importance is that the KPIs are mutually agreed and that the CRO is being honest about what they can execute and what the sponsor can realistically expect the CRO to deliver. At Linical we begin work on identifying these KPIs immediately after contract execution for discussion at the kickoff meeting.
While the sponsors and CROs may have different incentives, a strong governance structure can help to tie these together, creating alignment on shared objectives and fostering a forum where decisions can be made jointly as well as setting that is collaborative in nature and not one that is simply transactional. By setting an agreed collaborative structure, both the sponsor and the CRO can ensure that whole team marches in the same direction and meet shared objectives that are favorable for all parties.
At Linical, our philosophy is that the sponsor - CRO relationship is built upon mutual respect and trust, open transparent communication and shared accountability and desire to achieve goals. Culture and collaboration are just as important as excellent metrics in a high performing relationship. We strive to create an atmosphere with our partners that encourages transparency throughout the inevitable ups and downs of a clinical trial.
Linical treats governance as critical enabler of clinical trial success. It ensures quality, drives performance, mitigates risk, and fosters strategic alignment between organizations. In an environment where clinical development is more complex than ever, effective governance transforms our client relationships from transactional engagements into true partnerships, ultimately accelerating the delivery of safe and effective therapies to patients. Linical believes that organizations that invest in robust governance frameworks will not only reduce risk and improve efficiency but also gain a competitive advantage in bringing new treatments to market.
So let’s go back to the original scenario. Whether you are affiliated with a CRO or the Sponsor, take heart in knowing that the effort you are putting into overall project governance is fostering collaboration, increasing communication and ultimately accelerating treatment to patients that need it. Embrace the opportunity!
Author:
Doug Schallon
Project Director