Datatrial Ltd. :: Information Center

Case Studies

Partnership between Datatrial and CROfessionals Ensures a Rescue Study Meets Critical Timelines

After losing confidence in their current EDC provider, AnGesMG, Inc. a global biopharmaceutical company headquartered in Osaka, Japan, engaged Datatrial and CROfessionals to take over an important Phase II study. The principal challenge was to bring this study back on target given the aggressive timelines required. The synchronized efforts of
Datatrial and CROfessionals facilitated a very rapid and smooth recovery to ensure key timelines were met.

The critical factors for choosing Datatrial’s EDC solution were our quick study start-up, ease of use for the site users and CRAs, and the responsiveness from the study team. Another deciding factor for selecting Datatrial was the fact that the project manager running the
study was a clinical data manager who could understand the protocol and critical endpoints to the study. The project manager provided the EDC training to the sites, Sponsor, and CRAs as well.

“We decided to change data management companies because the existing EDC system was proving difficult to use and the training left us with more unanswered questions. We were not getting customer-focused service, nor value for the money being spent as out of out-of-scope
charges increased. Datatrial was willing to listen to our concerns and designed the EDC system so that it was easy to use and much more cost-effective. Training included answers to protocol-related questions as well as instruction on using nowEDC™. The system is easy to
navigate and the ability to pull up reports on any data points on my own is a big asset. Their ongoing flexibility and attentiveness are what keeps me satisfied with their service.” said Corinne Boettger, Project Manager at CROfessionals.

In addition to the aggressive timelines for the study, there was the added challenge of building a large Case Report Form (CRF). The CRF was complex with 28 unique pages, 133 repeat pages and over 600 edit checks that needed to be programmed. Because Datatrial’s study build process is so streamlined, studies can be built and deployed quickly.
The build for this study began in February 2006 and the system went live in March 2006. The study design and testing took six weeks from the study build to UAT to deployment live.

By partnering together, Datatrial and CROfessionals were able to turn the study around and meet the critical timelines needed. This study was conducted primarily from Datatrial’s US headquarters; however CROfessionals and AnGesMG, Inc. benefited from the Datatrial’s global presence and experience. By working globally, the workday was extended through support from both the UK and US offices.