Life Sciences

What To Do When An Outsourced Clinical Trial Hits A Roadblock

clinical-trial-rescue-studies

 

Let’s face it: Keeping clinical trials on schedule is not easy to do. Whether a sponsor runs into issues with quality, timeline, personnel, or myriad other things with an outsourced partner, it’s crucial to address the problems as soon as they’re identified.

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There are a few routes a sponsor can take when a study hits a roadblock. One option is to have a third-party step in, assess the situation, and oversee the original partner until study close-out. Another option is to have a third-party rescue the study in its entirety.

As you decide which option is best for your company, consider the following:

  • How soon does database lock need to occur? If the DB Lock date is a ways out, it might be best to have a third party come to the rescue. But, if there are only a couple of weeks remaining, transferring the study is probably not feasible, as it could push timelines out even further and potentially increase costs. In this case, the best solution might be to keep the study where it is, but have a third party step in and take the wheel.
  • Who has possession of the database? If your database is sitting with the organization that was originally contracted to conduct your study, moving it to another company could pose a significant challenge, as that alone requires more time and money. However, if your system is already being hosted by a company that also provides study setup and rescue services, handing it over to them is often the quickest solution with the least impact.

Far too often, a sponsor chooses a partner based on price and then the partner fails to deliver as promised. Over the years of implementing clinical data management and EDC systems, as well as managing studies for CROs, I’ve learned two key lessons about outsourcing: (1) pay extra attention to the data quality produced by the partner, and (2) never accept promises that seem too good to be true. If you keep these two things top of mind when selecting your outsource partners, you’ll have a better chance of avoiding roadblocks all together.

If you’re currently in a pinch with a clinical study and need a third party assessment or rescue, let us know.

About the Author

Tammy Dutkin is a seasoned professional with more than 20 years of experience in clinical research and data management. As director of clinical data management and EDC in Perficient's dedicated life sciences practice, she is responsible for the overall development and management of the department's clients and projects. Her core competencies include operational excellence, training, process and technology development/implementation, and quality management. Prior to joining Perficient via the acquisition of BioPharm Systems, Tammy was the senior vice president of operations at DSP Clinical Research and the vice president at Advanced Clinical.

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