DatStat Online Seminars

Surviving an Audit – Compliance vs. Validation

held November 2013

Presenters:

David Nettleton Renee Petrie

David Nettleton
Founder & Consultant
Computer System Validation

Renee Petrie
Sr. Director, Healthcare Solutions
DatStat, Inc

Overview:

It’s time for an FDA audit. Will your site pass the test?

Clinical trial sponsors need to know that each of their sites is operating according to protocol, GCP, and FDA requirements. Likewise, sites and CROs interested in attracting new studies must demonstrate their ability to meet these requirements. Validation is the fastest, most affordable way for everyone to be assured that trials are fully-compliant.

David Nettleton, author and FDA compliance expert, detailed the 14-step process used to validate computer systems used in clinical trials and explain the roles that vendors, sites, and sponsors must play in the process. Next, Renee Petrie of DatStat discussed how the validation process supports the drive to reduce study duration and lower costs.

Key topics

  • Understanding 21 CFR Part 11 vs GCP
  • Security requirements for EDC/CDMS software
  • ROI of compliance and validation
  • Beyond software – other requirements for validation
  • Roadmap for compliance

DatStat overview

Following the session, participants were invited to participate in an overview of the validated EDC/CDMS technology and services provided by DatStat.

Who Attended?
  • Clinical research sponsors
  • Research coordinators
  • Principal investigators
  • Research assistants
  • Clinical research professionals
  • Clinical Trials Office staff
  • Shared resource and core facilities staff
  • Electronic data capture (EDC) or informatics professionals
  • Current/prospective DatStat clients
Electronic Data Capture

40% reduction
in time to lock

Our cloud-based, patient-centered eClinical platform is ideal for CROs, sponsors and investigators seeking to uniquely engage patients and streamline their clinical trial process.

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