Racha E.

Main missions in Clinical Trials Digitalization & CSV

🔹 Digitalization of procedures – e-signature, e-consent, remote monitoring.

🔹 Decentralized trials – deployment outside traditional sites (teleconsultations, home-based follow-up).

🔹 CSV (Computer System Validation) – validation of CleanWeb (Telemedicine, GxP software) with quality, cybersecurity & CSV teams. Coordination, validation process, testing, documentation.

🔹 Data Management – eCRF design, database documentation (CRF annotations, DMP, DVP), validation of CLINICAL (Biokortex) for Cerba Research.

🔹 Regulatory compliance – Privacy Impact Assessment (MR001) to ensure patient data protection.

💡 Value added: improved project quality, ensured regulatory compliance, facilitated the adoption of digital tools in clinical trials.

• Support the global team in any activity related to the COA & eCOA (submission, training, translation, shipment)

• Coordinate, facilitate and conduct training

• Develop eCOA/COA planning and follow-up closely licensing agreements

• Manage COA printings and resupply

• Review booklet/CRF pages related to eCOA/COA and verify content including the copyright statement

• Verify accuracy of the contract proposals

• Vendor coordination by ensuring a completion of the activities within the agreed timelines (Project Desgin Specifications, UAT, translations, review of documents ... ) . Identify and communicate lessons learned/CAPAs related to eCOA/COA activities. Animate lessons learned presentations.

• Verify the completeness of EC submission package

• Mentor other eCOA CTOMs

• Support of Clinical Trial Manager of eTMF activities

• Implementation of eTMF system

• Quality control of documents in order to be "inspection ready" and indexing