Implementing a Paperless Trial for Phase 3: A Biotech's Lessons Learned
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
423
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
Location:
252AB
CHAIR
:
Mary R. Flack, (SCHNON), Vice President, Clinical Research, NanoBio Corporation, United States
Dr. Flack has nearly 20 yrs of clinical rsrch experience at NIH and pharma. She was Clinical Dir of Endocrinology and Women’s Health Care at Pfizer where she was responsible for clinical dev of pharma products for osteoporosis, hormone replacement therapy, fertility and contraception.
SPEAKER
(S):
Evonne Roberts, (SPKNON), Director, Business Development, assisTek, United States
Evonne is the Director of Business Development at assisTek. Her career began as an engineer in the semiconductor sector, specifically in mobile power management and connectivity. Her interest in technology was a perfect fit for transitioning into mobile data collection for clinical trials.
Dr. Manasco has conducted clinical research for over 30 years at the NIH and as an executive at GSK. For the past 5 years, as Co-founder of PharmaVigilant, she has been delivering technology to make the entire clinical development process faster, more efficient, and cost effective.
Description
This session will discuss how a small biotech implemented a paperless trial for a phase 3 trial using electronic source, eTMF, IVR, and a reporting tool to "integrate" all the data.