Steps to Paperless Clinical Trials: Certified Copies and More
Complion Free Educational Webinar
Presented by: Betsy Fallen, Global Head of Program and Business Development, SAFE-BioPharma Association
The drug development stakeholders at Sponsors, CROs, Vendors and Clinical Sites are transitioning to adopt technology solutions for efficiency and enhanced compliance. With that objective in mind, the requirement or need to retain the paper version of the Essential Documents becomes burdensome and an obstacle to progress. With incremental changes, this progression can move forward.
Learn three critical steps to moving to a paperless process while remaining compliant:
- Printing and Scanning - Many documents today are scanned images. If a born-digital document would remain digital, the need to print and manage a paper copy would be eliminated. We’ll share tips on how to go about adopting this concept.
- Certified Copies - For those paper documents that continue to exist as scanned images, especially wet signed documents, many organizations continue to require the retention of the paper. There are some that have developed processes for designating ‘certified copies’ and destroying the original paper. We will review opportunities to develop these processes to eliminate the need to retain paper.
- Digital Signatures - In the regulated environment of drug development, there are many requirements for approvals by designated experts or decision owners to ensure alignment with regulations and guidelines. These approvals, in a paper world, were typically accomplished with a wet signature. We will review the requirements for signatures recognized by clinical research and alternatives including digital signatures and technology solutions to replace wet signatures as a means of approval.
Come join us to learn how you and your organization and partners can assess and adopt processes and technology solutions to leap toward a paperless trial.
About Betsy Fallen - Ms. Fallen is an authority on the business processes and associated use of information technology in drug development. A passionate advocate for moving life sciences business on-line, Betsy is an expert on IT in regulatory and clinical operations, data management, and ancillary supply chain, among other areas.
Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.
Trained as an RN, Betsy is dedicated to ensuring the voice of the patient is heard as the drug development process continues the progression towards innovation and efficiency.