Conducting clinical trials is an intense exercise in risk management. From patient safety to regulatory scrutiny to every dollar of investment, risks are plentiful and threaten the successful delivery of potentially life-saving therapeutics. Like many business challenges, risk management comes down to an organization’s approach to oversight to provide the right mechanisms for accountability and to ensure the sponsor is aware of what’s happening across all aspects of operations. This bears repeating: Sponsors, you must have a means to access the activity taking place in your TMF, in your investigator site files, at your investigative sites…everywhere.
For part 1 of our oversight series, let’s talk vendors. Ensuring quality assessment and review processes are in place is essential. Getting all of that correct means starting out on the right foot.
Contracts and agreements do not tell the whole story, but they tell a lot about alignment. When it comes to vendor relationships, there are few things more important than alignment. Particularly as it applies to study protocol and regulations, as these supersede any internal, organization-specific processes. Vendor contracts must demonstrate this understanding by specifying your essential processes they will be responsible for, but you’ll want to be extra certain they are detailing exactly how they will respond to your regulatory requirements. When it comes to vendor collaboration, this is the real starting point for a positive engagement. Especially considering the fact that oftentimes your contractors have contractors. Do you know how they are being managed and held accountable? Ultimately, you are the one that answers for their actions. You will want a thorough account of sub-contractor relationships and oversight.
Sponsors often employ vendor assessment questionnaires to gather these important details early in the process. These questionnaires tease out information on the kinds of plans vendors are offering. Do they have a project management plan? A TMF management plan? What procedures are in place to ensure they are operating under all SOPs related to your TMF management? Do these plans include monitoring throughout the entirety of the project? Do they explain how they will measure their performance and handle escalations? To protect your research, you have to hold your vendors to a high standard.
First, please give your vendors feedback—it helps everyone win. Positive or negative, establish a rapport from the beginning where feedback flows freely and communication is open. Getting your vendor-monitoring process in place right away can help to maintain a healthy dialogue. Something as simple as routine project meetings can go a long way toward keeping everyone on the same page. Oh, and make sure they are metric based! Depending on where you are in the lifecycle of a study, information such as sites activated, sites missing documents, sites experiencing IRB approval delay, and many more milestones are examples of helpful measures of success and, for the future, trend analysis.
All of these measurements keep the current efforts in check, but they also serve as a basis for comparison for future research. Knowing things such as which sites tend to move faster/slower, where you ran into hang-ups with site files, and where you had issues in your TMF management are all practical observations that make your organization better at conducting studies with or without outsourced support. Understanding trends is an easy win you can provide to your organization for continuous improvement. These metrics should be defined early, often in collaboration with your vendors.
Along with these measurements there should also be processes for course correction. Corrective and preventive action plans (CAPAs) with clearly defined steps are essential for staying on track when something doesn’t go as intended. Oversight with no CAPAs in place just leaves you stuck and vulnerable to compliance risks.
With basic mechanisms of assessment, performance evaluation, and a plan for using your project to inform improvement, you can focus on the more granular details. One thing is certain in clinical research: There will be documents! Endless documents! No matter how many there are, sponsors have to maintain an awareness of all of it—this , of course, is why this work has been digitized. However, digital or otherwise, your vendors are going to contribute documentation in collaboration with or independently of your teams, and you have to be able to review and understand what they are doing and why. Depending on the nature of your work together, they may be responsible for monitoring visits, data management plans, statistical analysis plans, deviation logs, audit trails, site docs, and more. Picking just one of these items to serve as an example, a sponsor has to be able to discuss a deviation and make sure all related information can be found in the quality management system. No sponsor should find out suddenly that there have been five or six protocol deviations. Co-monitoring visits are an easy way to ensure CRAs are doing their due diligence and no such information creeps up on you.
Escalation plans are necessary for following through with CAPAs and holding all parties accountable. If a deviation occurs, everyone responsible must be aligned to take corrective action. While the vendor may be tasked with managing certain aspects of operations, the sponsor is responsible. Part of gaining confidence in the escalation process is understanding exactly the kind of support you should expect from your vendor by being crystal clear about what has to be delegated to them.
For more information on outsourcing TMF management or e-clinical solutions for your study, contact us at email@example.com.