Back on Track With IVD Feasibility in Less Than 5 Days: A Case Study

The challenge

Our client (a Sponsor, leader in IVD technologies) is in its feasibility and startup stage for a new clinical trial in the IVD space. The challenge they were up against is that IVD clinical trials are under slightly different regulations than other trials and the sites they need are usually labs that are not necessarily involved with traditional clinical trials as such. 

They contracted one of the top 5 CROs because of their global scope and experience in medical devices research. Yet, the CRO could not identify any experienced sites within their database. On top of that, the start-up team was challenged with the specific IVD requirements in some of the countries they had selected. 

The approach

1. We partnered up with the sponsor and the CRO to identify all available sites in the TrialHub database and match them to the CRO’s database. This way we identified sites that were missing in their lists. After the CRO start-up team contacted them it turned out that they were a network of labs that have a solid experience in running trials in IVD and were a great fit for the study. Execution timeline: 15 mins for extracting a list of relevant sites and 1 hour for matching them to the CROs list of sites. 
2. The sponsor decided to use TrialHub’s Local Experts Network to find out more about the start-up timelines in Denmark. The advisor that matched best to their requirements and needs was able to provide a full report of the start-up procedure in Denmark together with timelines and recommendations that the CRO was able to use in order to speed up the process in the country but also identify patterns with other countries. Execution timeline: 3 days to match with the local advisor, get and verify the information and provide it in a summarized report ready to be shared. 

The results

Both the sponsor and the CRO were working on tight deadlines which were not feasible once they faced this challenge. After TrialHub’s input with data and expertise, they were able in less than 5 days in total to get back on track with their feasibility and continue with the start-up process.