24.Jul.2012

OCT is awarded the first rescue data management project

The project of clinical study was ongoing at that moment with more than 100 patients enrolled by OCT-Clinical Trials in Central and Eastern Europe.

OCT is experienced in rescuing stalled clinical projects and restoring clinical trials back on track as soon as possible. Though this is the first time when one of our clients reached out to us asking to perform Clinical Data Management rescue action. The project was ongoing at that moment with more than 100 patients enrolled by OCT-Clinical Trials in Central and Eastern Europe. Electronic Data Capture (EDC) system being created, and managed by another vendor was not working correctly which required urgent actions. Different type of issues can develop during the data management process which might raise the possibility of timeline delays. Inadequate vendor performance, lack of resources, or different internal and external factors can set back the entire clinical data management process or the whole study program.

Our client, a small biotech company from the US needed Data Management rescue assistance, and the EDC system used in the trial altered the data. It was decided that paper Case Report Forms (CRFs) should be used this time which requires all the study data to be entered into CRFs manually. More than 400 patient visits were performed and all the patient data needed to be entered into paper CRFs without any loss and checked for errors in a short time frame. After the data is transferred, OCT Clinical Data Management System is planned to be used till the end of the trial.

OCT-Clinical Trials in CEE Data Management group developed the study-specific CRF template and database design in a 10 days’ timeline. OCT monitors performed CRF trainings for all investigators and site team members. All investigators are now set to start entering data into a new CRF. It was decided that additional monitoring visits will be performed in order to rapidly check CRFs, collect the missed data and put the data management part of the trial back on track.

OCT provides customized clinical data management assistance to pharmaceutical companies, biotech and contract research organizations to meet crucial timelines.

We offer the following Data management rescue services:

  • Fast Data Entry
  • CRF Tracking
  • Query generation, Tracking and resolution, etc.
  • Collection and Archiving of CRFs from Investigator's sites
  • SAE Reconciliation
  • 100% Quality control of data