(Recorded on March 20, 2013)

Summary:

As the use of digital signatures in eClincal and GCP applications has grown, so has the confusion about digital signature standards, compliance requirements, the role of SAFE BioPharma, and proper use of digital signatures in life science enterprises and collaborative cloud applications.

Join us as we clarify the important considerations for implementing digital signatures in eClinical. We’ll discuss the requirements set forth by the FDA and other regulatory authorities; legislation in the US, Canada and EU; deployment and adoption of digital signatures within the enterprise; and key considerations pertaining to cloud services (SaaS).

Key topics will include:

• How digital signatures eliminate costs, enhance collaboration, enable shorter site initiation times, and ensure timely automated reporting by project managers, CRAs, and site personnel
• How some of the largest biopharmaceutical companies and CROs use digital signatures to ensure document security and compliance, and to efficiently support FDA audits
• How eClinical portals can be enhanced with digital signatures used for signing regulatory packet (eTMF) documents

Speakers:

Rodd Schlerf
FDA Markets Manager
ARX

With over 25 years of experience in electronic signatures for FDA-regulated markets, Rodd Schlerf has led ARX to be the largest supplier of digital signatures in the FDA regulated industry. As a result, clinical operations organizations around the world are benefiting from reduced costs, faster operations, regulatory compliance, secure document exchange and electronic submission to the FDA.