In the world of Trial Master File, path to fully electronic Trial Master File still seems far away for many companies. This presentation discusses how this was accomplished within a Global Pharma company for Clinical Data Management. It walks through from inception of the idea as a company’s strategic move, stake holders involved, requirements session, configuration considerations, overall picture of how the ultimate processes would be. It compares what the process was before and after eTMF implementation along with business gains associated with the change.
This will also cover Business adoption, strategies involved in making better business adoption of change. Various strategies involved in getting inspection ready eTMF and how to build quality into processes at many levels. Benefits of having clear business processes with the business adoption are also discussed. This provides insight for audience into implementing cutting edge technology, with good business processes to lead to better Trial Master File for the companies involved.
By attending this webinar, attendees will learn:
- eTMF (electronic Trial Master File) implementation within major Pharma Company Clinical Data Management
- Best Practices, usage of eTMF reference model, tool used and limitations encountered
- Global implementation considerations
- Efficiencies gained, business process development considerations
- Obtain an ultimate vision of the project from a business perspective
Who should attend
This webinar is tailored for Clinical Data Managers, ITs, Essential Document Management Staff and intermediate users with knowledge of basic Document Management Principles.
Meet the Instructor
Ajitha Gadangi, Associate Director
Ajitha Gadangi is Associate Director at Merck. She has a Masters in Computer Sciences, and has over 20 years of System and Software Validation experience. She has been working in the Pharma industry for 13 years with increasing responsibilities. She has expertise with Data Management, Document Management, Quality Control, Quality Assurance, Process Management, Project Management.
She was a member of the core team that has been worked on implementing eTMF for Clinical Data Management at Merck and has acted as Zone Lead for Data management within TMF Reference Model group.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.