Service Description

Clinical Operations (i.e. Feasibility,clinical trials site selection, Monitoring, Project Management) Data Management (incl eCRF) Statistics Medical Writing Safety Services

What Went Well

Chiltren provides a well dedicated team, which pro actively set up the trial together with us. Problems and issues were quickly addressed. Solutions were developed together. The investigators and the personnel from the clinical trial site consider Chiltern and Sponsor as one party.

What Could Be Improved

There are not many things to improve. Normally upcoming issues were resolved on a on going basis. A lessons learned meeting was held in the midst of the study, to implement improvement not only in the next but also in the running trial.

Lessons Learned from the Experience

It is important to encourage your CRO to speak up. Once achieved, some planned processes and ideas from the sponsor were cancelled or modified. It is of great value, to participate from the CRO's knowledge and experience. However, you need to build up a high level of trust, before a CRO is willing to do so and the Sponsor is ready to take advice,