Case Study | Life Sciences
Cutting Clinical Study Build Time by 80% for a Global Pharmaceutical Company
Fresh Gravity helped a global pharmaceutical company cut its clinical study build time from 12-15 weeks down to 3-4 weeks, using our ML- and NLP-driven Clinical Study Automation Tool (CSAT) to automate CRF design generation.
At a glance
About the client
The client is a global pharmaceutical company running clinical trials that depend on Electronic Data Capture (EDC) systems, including Medidata Rave, to manage study data. Their EDC Programming and Global Data Operations (GDO) teams are responsible for translating study protocols into CRF designs and edit specifications for each trial, a process that sits at the center of study start-up timelines.
Problem
Producing a working draft of Case Report Form (CRF) designs for a given study typically took 12-15 weeks, delaying downstream data transformation, FDA delivery, and go-to-market timelines. The existing process was manual, error-prone, and inefficient. The client needed an automated solution that could streamline study set-up while meeting strict accuracy, speed, and usability requirements for regulated clinical data.
Solution
Fresh Gravity deployed CSAT, an ML- and NLP-driven tool that ingests a study protocol and generates CRF designs and Time and Events (T&E) schedule tables within minutes. After an NDA was signed, the client's standard CRF library, edit specs, and edit program files were shared with Fresh Gravity and hosted within CSAT. The pilot study protocol was then processed through the tool to generate CRF designs and T&E schedule tables automatically. The client independently evaluated the output against defined success criteria, including accuracy of field mapping, generation speed, and compatibility with Medidata Rave imports, using manually-built studies in Medidata Rave as the ground truth benchmark.
Impact
CSAT generated high-quality CRF designs and accurately drafted edit specs and programs from the CRF and Edit libraries hosted in the MDR, with CRF designs and associated metadata matching the conventional manual approach at a rate greater than 92%. Designs were produced in approximately 5 minutes. Finalizing, reviewing, and approving a full build still takes 3-4 weeks, down from the original 12-15 weeks, a reduction of close to 80% in total build time. CSAT's ability to ingest amended protocols and report differences across versions also gives the client a comprehensive change report in minutes. The successful pilot, which scored 70%+ in the client's independent evaluation, established Fresh Gravity as the client's preferred vendor for automated study build solutions, and the engagement is now running in production.