Combining a Phase I study with an ongoing observational study

Cmed’s Data and Analytics team demonstrate their commitment to provide flexible and innovative solutions to meet the requirements of complex clinical trial situations

 

Situation

A biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As the team started to plan their first Phase I study they realised that they wanted to align the data structures from both studies.

The observational study had been initiated in Openclinica but this was not a suitable solution for the sponsor. The preference was to adopt encapsia (Cmed’s proprietary EDC and analytics platform) to take advantage of its advanced analytical capability.

Challenge

Cmed needed to provide an encapsia database to:

  • Incorporate data for existing patients from the OpenClinica database whilst minimising impact on the sites and ensuring complete data integrity.
  • Capture and manage prospective data from existing patients
  • Capture and manage all data from new patients

 

 

Solution

Cmed specializes in innovative technical solutions for sponsors.

By applying previous experience of rescue approaches for clinical data, Cmed:

  • Built an encapsia database to meet needs for all prospective data
  • Worked closely with the client to appropriately map existing data to encapsia and agree comprehensive rules for handling non-standard situations
  • Used fully validated functionality within encapsia using bespoke requirements to import data extracted from OpenClinica, initially to a test environment and then to the live database

Impact

Cmed provided:

  • An efficient transfer of data with just days between data being extracted from OpenClinica and available in encapsia
  • A user-friendly solution which minimized the impact on busy site staff, avoiding re-entry of data and allowing easy prospective data collection
  • An accurate and validated transfer of data which the sponsor knew would stand up to regulatory scrutiny
Case Study Key Facts    
Disease/indication Solid malignancies
Size of study 5 sites, 120 patients
Client type Mid-size biopharmaceutical company
Client base California
Project timeline 2019
Other background Our client selected the Cmed Data and Analytics team with encapsia for this project for our expertise and technology to integrate multiple data types from multiple sources into a single database

Tell us about your clinical trial
program and how we can help