Smart, Audit-Ready Data Management

BUSINESS CHALLENGE

To improve its data management services—and facilitate audits—ProTrials Research, Inc. sought to replace its existing electronic data capture (EDC) system and paper-based reporting processes.

TRANSFORMATION

A contract research organization (CRO) focused on quality, ProTrials needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. Now, with a cloud-based, unified IBM® Clinical Development platform, the CRO can quickly create accurate digital records of every action taken, including granting users access and updating study protocols.

RESULTS

30 minutes to perform a minor study change to in-progress studies, complete with the customer’s digital approval form

Around-the-clock activation and training with novel safeguards created using the IBM platform’s integrated workflows

Improved the company’s audit readiness and competitive advantage with newly digitized processes and documents