Exploring Data Management Best Practices
Clinical trials are evolving. Whether it’s technology trends, changing regulations, or external factors. The pace of change is only increasing – along with
the complexity of ensuring your trial data is secure and compliant.
This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.
In this webinar, we will cover:
• How we are handling trials with COVID
• How technology is impacting trials now and what it means for the future
• How to get ahead of the changing regulatory environment (FDA, GDPR, CCPA, etc.)
Learn from industry veterans on how to future-proof your clinical trials.
Presented by
Alok Tayi, PhD,
Vice President of Life Sciences, Egnyte
Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company’s strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management practices for this domain. Before joining Egnyte, Alok was a Y Combinator-backed entrepreneur and started two vertical software-as-a-service companies. Prior to his career in software, Alok spent over 15 years as a scientist: he took part in postdoctoral work at Harvard University with George Whitesides, and has published papers in Nature and Nature Chemistry. Alok holds a PhD from Northwestern University and BS from Cornell University.
Heather Wolff,
Vice President, Clinical Development Operations, Decibel Therapeutics
Heather Wolff joined Decibel in February 2018 as the head of clinical development operations for Decibel Therapeutics. Heather is responsible for Decibel’s clinical operations, regulatory operations, medical writing and data management functions, providing leadership around the company’s development programs. She has a long track record in clinical development, with a focus on building and leading data management groups. Widely recognized as a leader in the space, she has been a key member of both large and small companies including Infinity Pharmaceuticals, Millennium Pharmaceuticals (Takeda), Accenture (ACE), Synta Pharmaceuticals and Genetics Institute (Wyeth). She played a role in successfully gaining FDA approval for Wyeth’s rhBMP-2 in the U.S. and E.U., and also facilitated the acquisition of sNDAs for Millennium’s Velcade product. Heather graduated from Skidmore College with a B.A. in English.
Key Learning Objectives
- How best to handle clinical trial data today
- How technology is impacting trials
- How to keep up with the changing regulatory environment
- Best practices and guidance for conducting clinical trials in the future
Audience
- Scientist
- Researcher
- Program Manager
- Scientific Leader
- Clinical Trial Operations
- Clinical Trial Management
- Data Scientist
- IT Director
- CIO
- CISO
- CTO
- Regulatory Affairs
- Quality Assurance
- Compliance Officer