Regulatory Submissions, Information, and Document Management Forum
Session 9 Track 3: From Sites to Health Authorities – Lessons Learned on Document Preparation and Exchange
Karen McCarthy Schau
- Director, Global Clinical Operations
- Vertex Pharmaceuticals, United States
An electronic document exchange system between clinical sites and a sponsor or CRO eTMF system has many benefits. There are also many challenges with regard to procedures, communications, training and user onboarding. The decision to deploy this technology to sites requires a long term commitment to building and maintaining integrations, streamlining user onboarding/offboarding and user support. The technology for electronic document exchange with clinical sites continues to evolve, but is still not widely adapted. A sponsor company will describe their strategy and experience with electronic document exchange technologies with eTMF.
Regulatory submissions are one of the most critical milestones for Life Sciences organizations and can consist of thousands of documents. Submitting on time & in full compliance with regulatory agencies' requirements, remains a challenge due to the process of authoring, reviewing, updating & formatting in tools like MS Word to strict guidelines before conversion for inclusion in dossiers. Life Sciences organizations adopt cutting-edge technology, but the technology alone doesn't guarantee compliance & that timelines are met. Efficient processes combined with technology does.
Regardless of the vendor and technology selected, you will learn about the challenges, benefits and the commitment to organizational change management that is required to achieve a successful deployment of both streamlined document preparation processes and document exchange.
Learning Objective :
- Identify the business drivers for selecting and using a clinical site electronic document exchange system
- Describe the benefits for using a system for electronic document exchange with the eTMF system
- Walk away with practical tips on how rendering technology can help streamline regulatory submission process
Electronic Document Exchange With Clinical Sites: Lessons Learned
Michael Agard, MS, RPh
- Managing Consultant
- NNIT, United States
- VP Life Sciences
- DocShifter, Belgium
- eClinical Manager eTMF and Collaboration
- CSL Behring, United States