Case Study : Rare diseases clinical trial in Europe

ExperTrials was contacted by a mid-size American biotech towards to the end of 2019 to take over an ongoing rare diseases clinical trial in Europe

They had started a multi-national clinical trial with an investigational drug for a rare disease in the USA and Europe, but were very unhappy with the recruitment progress, monitoring support, cost, and the quality of services provided by the CRO contracted for the European sites.

This CRO was amongst to Top 5 international big CROs, however our client and clinical sites did not feel adequately serviced and complained about lack of responsiveness and commitment from the global CRO, in addition to a high staff turnover rate.

ExperTrials accepted this challenge of a “rescue trial”, and not only took over regulatory responsibilities, monitoring and site surveillance for the active study sites, but also assumed the role of European legal representative for our US client. The handover process was a difficult phase, as could be expected, but within short time all European regulatory and site surveillance tasks and responsibilities were successfully taken over by ExperTrials.

Within 2 months, under ExperTrials’ leadership, a total of 6 subjects could by enrolled in this trial, whereas under the previous management by the former CRO not a single patient could be included for over a year.