Avani Amin has 18 years’ experience in TMF Management and oversight, having worked across multiple FSP TMF providers. Initially key member of the Project Management team supporting clients across the top 30 global pharmaceutical firms, Avani now co-leads the eClinical Solutions Management unit and the Study Owner unit at Trial Interactive, directing TMF Oversight across 200 keystone clients. In this capacity, she regularly oversees system implementation, provides best practice guidance, and ensures ongoing customer success for Trial Interactive premier clients.
Avani leverages her 18 years in the industry to provide accurate, clear TMF consulting for a range of customers; assisting clients with industry best practices, optimization of eTMF and CTMS systems, business process development, and SOP/TMF plan creation.
As the industry evolves with the onset of new technology, she is well placed to communicate accurately Regulatory expectations and TMF requirements to ensure clinical compliance across the CDGM space.
Gillian Gittens
Gillian Gittens is a TMF industry veteran with over 25 years’ experience, has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A key member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.
Henry Raley
Henry has been supporting clinical activity across the pharmacovigilance, CRO, and now TMF FSP space for 12 years; and has supported 50+ eTMF implementations and 30 FSP model activations in the last 18 months. Working across multiple support models, he remains a market leading expert in adaptable compliant workflows for full TMF compliance.
He works directly with sponsors, providing full TMF management, alongside CROs as a collaborative partner, and advises on appropriate technology platforms and configurations based on client need. He also sits at the forefront of the TransPerfect AI rollout, helping with AI for TMF Management, eCTD Submissions, and Medical writing.
