In 2019, ExperTrials was contacted by an American biotech to take over an ongoing rare diseases clinical trial in Europe.
In late 2019 a mid-size American biotech got in touch with ExperTrials about a multinational clinical trial regarding an investigational drug for a rare disease in the USA and Europe. They needed their study to be rescued. Do you know what a rescue study is? It is a clinical trial that was run by one or more CROs over time, but is contracted to continue with a different CRO due to one or several mishaps.
Some of the reasons a study needs to be rescued
In this case, the sponsor had multiple reasons to be unsatisfied:
- The recruitment process was not going as planned
- The monitoring support was insufficient
- The quality of the services were overall unsatisfactory due to a lack of responsiveness and commitment from the global CRO, in addition to a high staff turnover rate
How ExperTrials came to the rescue
ExperTrials was happy to take on the challenge and “rescue” the trial.
One of the obstacles our team faced had to do with the handover process: “We had to get in touch with the previous CRO to obtain the data related to the study and had to be quite persistent to get all the information we needed”, explains Christoph Wachter, appointed Project Manager for that study and also Head of Clinical Operations at ExperTrials. After overcoming that challenge, our CRO took over regulatory responsibilities, monitoring, and site surveillance for the active study sites.
Within two months, under ExperTrials’ leadership, a total of six subjects were enrolled in the trial. We also assumed the role of European legal representative for our US client. The study is now reaching close-out phase.
The key factors that made the study a success eventually
What are the key factors that turned this rescue study into a success?
The sponsor could rely on ExperTrials’ experienced and dedicated team and its staff continuity, a far-cry from what they had been used to previously. They were in touch with the same Project Manager throughout the entire trial. The horizontal management used in our CRO contributed to the trial going smoothly as well: our team uses streamlined communication and agile project management to provide our clients with tailor-made solutions.