Clinical Trial Blogs for Early Phase CROs: Effective Supplemental Vendor Management for Phase 1 Trials—Managing Vendor Relationships
While Phase 1 trial protocols share many similarities such as overnight confinement, serial sample collection, continuous monitoring, and safety evaluations, there are some study designs which will require procedures or assessments that aren’t as common. Some examples of such procedures are: Holter monitoring, X-rays, and esoteric laboratory tests, to name a few.
When it comes to procedures like these, we believe that some aspects of trial management are better left to groups which specialize in that functional area and performs those activities frequently, rather than attempting to bring the activity in-house with staff that aren’t likely to have the same level of training or experience with the equipment or interpretation of data. Thus, we encourage outsourcing when appropriate and when it will benefit trial conduct.
In the first of two clinical trial blogs, we discussed how early phase CROs can qualify vendors when they are needed for specialty procedures or assessments in Phase 1 trials. In this article, we will focus on how ongoing relationships with vendors can be managed in a way that encourages quality performance and results across multiple studies.
After the qualification process has been completed and preparations are being made for trial conduct, it will be beneficial to understand how the relationship with the vendor will be managed during and across several studies, if applicable.
We encourage that early phase CROs ask the following questions:
- During a study, who will manage the vendor? Will it be a project manager? Internal subject matter expert or the end-user? Ultimately, assignment should be to the person who is communicating trial objectives and expectations with vendors most frequently throughout the project.
- How will vendor management change if they are involved in multiple trials, perhaps simultaneously? In this scenario, a completely different approach than the above may be warranted.
- When a project is completed, how is the vendor’s performance reviewed and are “lessons learned” applied? This may not be necessary for certain types of vendors, but if their contribution to the study was significant, then timely performance evaluation is recommended. This is especially imperative if the vendor will likely be approached again to support another protocol.
There won’t necessarily be a single correct answer to the above questions, and answers may vary between organizations. No matter what the answer, the way the relationship is managed needs to make sense for the trial and be applicable to the specific functional area being covered.
It will be important to know that the early phase CRO managing your Phase 1 trial is able to maintain long-term relationships with sub-contracted vendors and specialty providers that can act as an extension of their team. If proper steps are not taken to identify, qualify, and communicate effectively with these providers, it can result in delays, increased costs, and risks to the integrity of data generated during the trial.
In an ideal situation, your service provider will maintain frequent communication with their outsourced partners to discuss current projects, perform feasibility on upcoming projects, and review previous projects in order to address any issues that exist and correct them as early on as possible.
We hope that this pair of clinical trial blogs prove to be resources for your upcoming project. Please return to our blog in the future for more helpful articles on conducting successful Phase 1 trials.