What’s unique in Tom’s experience is that it spans GCP, Electronic Records, and Privacy Regulations across multiple clinical trial domains, including EDC, IVR, data management and CDMS, trial monitoring, document management and eTMF, investigator site assessments and audit. Based in New York City and providing consulting services globally, he is the President of WTKoch GCP QA Consulting. Tom is dedicated to helping clients solve the GCP, privacy, and electronic records / data integrity challenges facing clinical trial sponsors and eCROs today.
His focus: enabling clients to achieve and maintain full regulatory compliance while fully meeting business needs and priorities. A certified privacy professional through IAPP, Tom’s experience also includes many years dealing with US and global privacy regulations as they impact clinical research, including HIPAA, Privacy Shield, and now looking ahead to the new EU GDPR 2018 implementation.
I stay on top of regulatory changes and compliance issues. Come back often to stay up to date on the latest changes.