Service Description

Full set up and project management of a Phase III registration trial in a rare cancer indication. This was a global study with ~130 patients across 10 countries and 44 centers. Quintiles were provided with the study design and were then responsible for the study from writing a study protocol through to a clinical study report. Therefore, Quintiles had responsibility for regulatory and ethics submissions, database set up, investigator identification, stuffy feasibility, other vendor service providers and outsourcing, running and management of the trial itself, reporting of data and production of the final clinical study report.

What Went Well

Positive examples of working with Quintiles: They provide a dedicated project manager for the clinical study who is responsible for all aspects of the service provided by Quintiles and other vendors. In our case the project manager we were provided had excellent communication skills and managed the set up and the trial very well. They listened to us as customers. For example, for study feasibility and set up we challenged some of their assumptions which they were quite open to which led to a better study set up. They were and are professional at all times. For example, running investigator meetings they provided and professional service and utilized us in the best way for the benefit of the trial and not themselves.

What Could Be Improved

Examples of improvements needed: Management of costs - it was very difficult to finalize the budget with Quintiles as costs seemed to change on a weekly basis and made it difficult to agree a final figure. Improvement of how they estimate costs and the tolerances they provide is necessary. Recognizing their lack of experience. As we were all working in a rare cancer type we are all still learning, however, Quintiles were at times adamant of their knowledge despite this being the first time they had done this type of trial. They need to improve how they portray themselves and recognizing a lack if knowledge in certain areas is no bad thing.

Lessons Learned from the Experience

I do not think Quintiles thought outside the box however, they did and still do provide an excellent project management service of a pivotal study. I have learnt that communication is key to making the collaboration with the CRO work, i.e. we did not just handover the study design specification and 'leave them to it', it has been about working closely with them throughout the lifetime of the study and the service they provide. I have also learnt that finalizing the budget is key to smooth start to the study and if costs continue to risk it is difficult to focus on delivery, particularly if there is lack of clarity on both sides.