Parexel Review: Clinical study set up to final clinical study report

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195 West Street
Waltham, MA 2451
United States
(781) 487-9900

Clinical study set up to final clinical study report

Overall: 1 stars

Date: June 24, 2014

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Service Description

The CRO was contracted to take care of all services (Clinical, Project management, contract management-third party vendors stats, Datamangement, medical writing from clinical set up (including Ethics committe/Health authorities) to Trial Master File finalization

What Went Well

They set up the Multi-site studies, which went reasonably well but this depended on how experienced the CRO project manager was. Unfortuantely I cannot think of any others areas that went well as there are many of their internal services which need improvement and very quickly.

What Could Be Improved

The CRO lacked proactivity: We, the Sponsor had specific timelines to be met and Parexel always pushed back on these and needed more time to set things up. Budget estimates and contracts were always wrong; meaning a lot of our resources were required to review on numerous occassions. The stats departmental was diabolical. So many errors in the SDTM sets. So much so that we are thinking about bringing this service back into house. The sponsor's project manager's actually spent 85% of their time following up with the Paraxel team asking for updates and trying to psuh things forward. The say they have a massive data base of patients/healthy volunteers but in reality we always had difficulty with Paraxel recruiting for our studies

Lessons Learned from the Experience

We (Early Phase) began working with Parexel UK and Germany, approxiamtely two years ago as a partner. Through our experience the German unit in Berlin appears to adapt a more can do attitude than the unit in London. It is a constant struggle to work with the UK team, so much so that we are considering working with another CRO if they do not improve. We have a lessons learned twice a year and the same items appear at those lessons learned, so nothing has changed. They talk the talk (very good at that) but don't walk the walk.