Register Now!
ClinPage members can listen to full-length podcasts and download podcast transcripts.

Forgot your password?
Sponsored by
Guest: Anthony Costello

Clinical Data in 2017

February 14, 2008
LENGTH: 9:00

The burden of day-to-day responsibilities does not always allow for appropriate reflection on the future. The Society for Clinical Data Management is trying to address that next month in its annual Leadership Forum. Held in Durham this year, it’s for senior-level executives. Space is limited. It’s an intimate, forward-looking gathering intended to allow peers to discuss what they’re grappling with in depth.

This year’s event has been reformatted to have more access to industry thought leaders and FDA officials who will be charting the future of clinical data for the next ten years. All of the presentations at the Forum will be conducted in an intimate, free-form manner to faciitate in-depth discussions between peers. 

In this podcast, Anthony Costello, a past chair of the SCDM and a co-founder of Nextrials, discusses some of the highlights for this year’s meeting, including a peek at CDISC’s CDASH forms and an update on a promising integration of electronic health records and 21 CFR Part 11-compliant systems for clinical trials.

the agenda for the meeting.

In talking with Costello, it’s clear the SCDM wants to have this be a meeting that helps attendees be ready for the long-term future that awaits them. Here’s how Costello put it: “We don’t just mean next year. We mean the next several years. Where will data management go? Where will clinical trials go? Where especially is technology going, because it’s changing so quickly? And how can we get the best and the brightest people in the room and really think about how our industry is going to change over the next five or 10 years?”

There are several high level FDA speakers on the agenda of the meeting, including Rachel Behrman. We asked Costello about that. “Obviously, FDA created the Critical Path initiative to be a leader in this space. So it just makes sense to have the leaders from the regulatory body participating in an open forum like this with the leaders from the industry.”


May 26, 2019

Guest: Michael Ibara, Pfizer

Between A Rock And The FDA

Michael Ibara, head of pharmacovigilance information management at Pfizer, discusses the intricacies of how to manage drug safety data in an increasingly electronic age. But the context of his remarks is much larger, and involves how both industry and government may be able to convince the public that all reasonable measures are being made to keep medicines as safe as possible. 

Guest: Roy Vagelos, Merck

Merck’s Finest Hour

Roy Vagelos may be retired, but he remains a legend all the same. The former Merck leader spoke at this year’s Clinical Trials Congress. 

Guest: Landen Bain, CDISC

Eclinical, Health Record Integration

In 2009, it is easier and more feasible to connect two vast data cosmos that have long existed separately. The electronic data capture (EDC) systems for clinical research are slowly being connected to larger, more general-purpose electronic health record (EHR) systems for physicians. 

Guest: Paul Clarkson, Genentech

Podcast: Making Smart Protocols

As a trustee of the Society for Clinical Data Management (SCDM), Paul Clarkson is the archetype of the data manager who understands the largest issues affecting clinical development. As director of data management at Genentech, he’s been thinking about how data managers can help their organizations develop better protocols. 

Guest: Anthony Costello

Clinical Data in 2017

The burden of day-to-day responsibilities does not always allow for appropriate reflection on the future. The Society for Clinical Data Management is trying to address that next month in its annual Leadership Forum. 

Guest: Carol Rozwell

The Case For Standards Now

Gartner’s Carol Rozwell is one of the industry’s leading authorities on technology adoption and clinical data standards. In this illuminating interview with ClinPage editor Mark Uehling, she discusses why some organizations hesitate to use CDISC standards and how some contract research organizations (CRO) have recently begun to see data standards differently. 

© 2019 ClinPage. All Rights Reserved.