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‌Deep Dive: Case Study – R&D Clinical Operations

Updated: Jan 12

Problem Statement: Using legacy CTMS technology that was not adaptive to today’s clinical trials, lack real time visibility and was difficult to integrate with other clinical systems, an eTMF system which exists yet is not Inspection ready and missing key functionalities together lead the business operations team using spreadsheets and emails for tracking and reporting, increasing inefficiencies, duplicating data entry, and providing limited visibility across clinical trials.

Transformation towards Unified Clinical Vault Operations

Vault eTMF:

  • ‌Transform the legacy eTMF system with Next generation Veeva Vault eTMF.

  • Migrate the TMF documents from ongoing, closed & archived studies.

  • Build interim CTMS -> eTMF inbound integration for basic study data and transfer monitoring visit report TMFs.

  • Build outbound transfer from eTMF to Submission applications.

  • Finally decommission the legacy eTMF system.

Vault CTMS:

  • ‌Followed by the transformation of the legacy CTMS system which manages the clinical trial data and processes to the same vault application that manages eTMF and adopt all the core CTMS functionalities.

  • including a complex migration of legacy clinical trial data to the Vault system successfully.

  • Build multiple inbound / outbound integrations for clinical trial data.

  • Finally decommission the legacy CTMS system.

Vault Study Startup:

  • Build & Establish Study Startup capabilities to accelerate time to site activation by bringing together start-up content and data,

  • Incorporate country-specific intelligence in study start-up workflows.

Key Implementation by our Experts: (not limited to the below)

  • Setup Robust custom User security and enhance/optimize/maintain for different user types from Internal Business, Contractors, external CROs, Site Users, Inspectors etc., consuming CTMS, SSU and eTMF with Global, Study, Study Country and Study Site level accesses, hybrid accesses, treatment revealing information access controls - Blinded and Unblinded, integration data / tmf's security etc.,

  • Adopt Milestones <-> Expected Document Lists based on the functional areas - eTMF (Inspection Readiness) and SSU (Country Intelligence) and CTMS are configured to-be auto-created based on the study lifecycle progression and any further maintenance towards the Milestones & EDLs.

  • Adopt Veeva Standard Archival features in the customer unified vault and have one solution fit for Archival, Un-Archival, Re-Archival of study related data's and tmf's with required archival security established for users, archivists and administrators.

  • Enhancements & Customizations in the CTMS space as per the specific customer business process in the functional areas: Subjects, Metrics & Recruitment planning, Monitoring Event & Trip Report Administration, Issue management, Global Directory management etc.,

  • Configure and Implement Risk Based Study Management to allow users to apply risk-based practices to study management aligning with Veeva standards and customizing to the required extent of the internal customer business process.

  • Adopt CTMS Yuzu functionalities for the business running clinical trials in Japan and configured the ability to generate and submit Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA).

  • Configure Checklists to eliminate forms outside the system and design forms which enable users to respond to series of questions in form-filling UI and perform review / approval inside the system.

  • Configure Site Activation Progress view on Study Start up to view document completeness across sites at a glance.

  • Adopt & Customize "Quality Issue" in the eTMF space to create and assign issues and quality checks, track who is responsible for fixing specific issues, and report on the number of open issues etc.,

  • Implement changes related with TMF Index management as per the customer business index team requirements and adopt the Veeva standard TMF Index Management module to govern the TMF index inside the vault and eliminate manual work and process outside the system.

  • Implement custom document workflows (single/multi document) with eTMF space: Paper Copy Certification workflow, TMF Authoring & Review workflow, TMF Approval workflow with eSignatures, TMF Quality Issue workflow, TMF Soft deletion workflow, TMF Distribution to Sites etc.,

  • Adopt TMF BOT and train the model to auto-classify the tmf's from the users inbox.

  • Adopt standard mobility / desktop applications and make the most of the product benefits to customer: Implement Veeva Snap App (Apple iOS app to capture and upload tmf's and certify from devices), Vault Mobile adoption (both android and iOS). Vault File Manager to efficiently edit, check-out/in the tmf's.

  • Configure Simple TMF Transfer for seamless transfer of study data and tmf's from CRO to Sponsor eliminating migration efforts or projects.

  • Last yet not the least - using Veeva Vault java SDK framework - customized complex specific business process requirements which could not be fulfilled with the configuration capabilities in the system and deployed.

‌‌Benefits: Unified system to manage clinical trial data and trial master files and to support the study startup capabilities which not only ease the user experience and increased efficiency in the clinical trial process and accelerate trial execution and deliver real-time visibility.

"Lifescience IT Consulting" "Veeva Vault IT Services" "Veeva Vault Development" "Veeva Vault Migrations" "Veeva Vault Integrations"

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