IDDI Improves Collaboration, Control, and Audit-readiness in the Cloud with Veeva Vault eTMF

Before moving to Veeva Vault eTMF, IDDI was burdened with a cumbersome hybrid system of paper-based processes supplemented with electronic shared drives and e-rooms for sharing documents with its clients. Users turned to unsecured workarounds like email, and the complexity prevented effective collaboration with sponsors, independent data monitoring committees (IDMCs), and internal teams around the world. Paper documents proved too difficult to access and track, and the organization turned to shared drives to give sponsors access to content electronically. However, these shared drives were only accessible off-site by using a VPN. E-rooms were meant to provide more flexibility, but limitations in the e-room access control model created a new set of challenges and security vulnerabilities, leading to serious compliance concerns. Lacking true content management capabilities like workflow, reporting, and audit trails, these file shares functioned largely as document storage, and had to be cleared periodically to make room for new documents. Facing an impending audit, IDDI decided to print all electronic documents to create a paper-based TMF. Despite the time and effort expended to compile trial master f ile (TMF) documents from disparate sources, audit-readiness remained challenging.

International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology. IDDI optimizes the clinical development of drugs, biologics, and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston, Raleigh, and Cupertino. The organization is committed to providing the highest quality of services, exceeding customer expectations, and ensuring patient safety. IDDI's mission is to provide accurate, timely, and cost-effective services that are tailored to the specific needs of each client. The organization's team of experienced professionals is dedicated to delivering innovative solutions that meet the unique needs of each project, from early phase to post-marketing studies.