Hello, my name is Tom Koch. I help bio/pharma companies meet regulatory challenges in GxP and data protection/data privacy.

Can you demonstrate how the integrity of your clinical data is maintained? Are your audit trails secure and periodically reviewed?
Are your electronic records Attributable? Legible? Original? Accurate? Complete?
Have you updated your operations and procedures to meet ICH E6(R2)?
Are your data flow diagrams accurate, up-to-date, and complete?
How is your provider helping you maintain the integrity of your clinical data?
How will the GDPR affect your clinical trial data collection and processing?
Are you inspection ready? Are your vendors?

About Tom Koch

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.

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Check out some of my latest Blog Posts

I stay on top of regulatory changes and compliance issues. Come back often to stay up to date on the latest changes.

 

I live in Fabulous New York

but my clients are global in scope.