Case Study: Clinical Research Organization achieves FDA-compliant, accurate document rendering with Adlib Software

Rendering Research with Compliance at Stake

Clinical Research Organization faced the challenge of converting complex research documents and FDA submissions to PDF while maintaining archive copies in industry‑compliant formats. The CRO needed to demonstrate FDA compliance, produce multipart research reports and submissions, manage documents with both short‑ and long‑term lifecycles, and ensure absolute accuracy. They engaged Adlib Software and its Advanced Rendering technology (Adlib PDF Enterprise) to address these requirements.

Adlib Software implemented its Advanced Rendering/Adlib PDF Enterprise solution integrated with the CRO’s ECM (SharePoint) to automate high‑volume, accurate document‑to‑PDF conversion across capture, manage, archive and deliver stages. The result was a complete FDA‑compliant workflow with accurately rendered documents, a streamlined conversion process that increased efficiency, and a flexible system for handling documents of varying durations—enabling the Clinical Research Organization to meet regulatory requirements and improve operational throughput.