Data Science & Analytics: Combining A Phase I Study with an On-Going Observational Arm

This case study looks at a sponsor biopharma’s challenge of wanting to align the data structures from both an ongoing observational study and their first Phase I study.

Aixial Group’s experienced team of data and analytics experts quickly came up with an innovative technical solution for the transfer of data and that stood up to regulatory scrutiny and minimized efforts of busy site staff.

Situation

A Biopharmaceutical company had an ongoing observational study with 120 patients in 5 sites. As they 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 they decided this was not going to be the best platform for them going forward and wanted to adopt encapsia (Aixial’s proprietary EDC and analytics platform) to take advantage of its advanced analytic functionality.

Challenge

Aixial 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 data from new patients

Solution

Aixial specializes in innovative technical solutions for clients.

Applying previous experience of rescue approaches for clinical data

Built an encapsia database to meet needs for prospective data
Worked closely with the client to appropriately map existing data to encapsia, and agreed 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

Aixial provided:

An efficient transfer of data, just days between data being extracted from OpenClinica and available in encapsia
A user-friendly solution which minimised the impact on busy site staff, avoided re-entering data and allowed easy prospective data collection
An accurate and validated transfer of data which the client knew would stand up to regulatory scrutiny

Reach out to us at info@aixial.com