It has been more than 20 years since the FDA established that electronic documents and signatures were trustworthy and acceptable for use in clinical research (so long as they meet 21 CFR Part 11 requirements). In that time, many research organizations have taken the opportunity to free themselves of the struggle to manage mountains of paper and chase down doctors for signatures. But many have yet to make the transition.
Polaris Compliance Consultants was delighted to present Complion’s October 24th webinar, “What ICH E6(R2) Really Means for Research Sites!” Far more questions were submitted during the webinar than we could address during the Q&A period, so we would like to answer them here. It was interesting to see that most of the questions related to documentation and document retention. That can be a confusing area for study sites. We hope you find these responses helpful.
Complion, the industry leading eRegulatory platform for clinical research sites, will be speaking and exhibiting at the 2018 MAGI West conference, taking place in San Diego, California October 21-24, 2018.
Complion Founder & CEO, Rick Arlow, will be a panelist on the session, ISF/TMF Integration, to share insights on how sites and sponsors can work together to ensure complete and accurate records and streamline regulatory tasks.
One of the most rewarding, exciting, and humbling aspects of the work we do here at Complion is that it allows us to engage with organizations that are leading the charge to develop new therapies to treat patients suffering from a range of ailments. Some exciting recent news puts one of our clients into the spotlight.
The National Cancer Institute (NCI) has awarded the Robert H. Lurie Comprehensive Cancer Center of Northwestern University the highest possible rating on the competitive renewal of its Cancer Center Support Grant. Along with the recognition for the excellence of its research programs and patient care, the Lurie Center will nearly $31.5 million in funding, a 36% increase over the previous award.
Complion, the industry-leading eRegulatory platform for clinical research sites, will be speaking and exhibiting at the 2018 Global Site Solutions Summit, taking place in Boca Raton, Florida on October 12-14, 2018.
Complion will be kicking off the summit by inviting site members to Miznar's Monkey Bar on October 11th from 8-11PM. Upon arriving to the Boca Raton Resort, attendees can enjoy wine and artisanal foods while listening to the acoustic sounds of Johnny Champagne or enjoying an outdoor bocce ball. RSVP is requested for those planning to attend this one-of-a-kind event!
Download your at-a-glance guide to choosing an eRegulatory solution.
As a research coordinator or administrator, being buried under a mountain of paper files is something that doesn’t have to happen often before the light bulb in your head suddenly glows with the realization that there must be a better way.
Light bulbs are clicking on in similar fashion across the industry, and their accumulated illumination is shining on eRegulatory systems. The rate at which organizations are adopting eRegulatory systems makes it quite clear that it’s only a matter of time before the eRegulatory bandwagon shows up in your site’s parking lot.
As recently announced by the Association of American Cancer Institutes, an abstract created in a collaboration by the University of Cincinnati Cancer Institute and Complion has been awarded first place by the AACI CRI steering committee and selected to be presented in formal sessions at the 10th Annual AACI Clinical Research Initiative Meeting, July 11-12, in Chicago.
Selected from among a record 68 submissions, the winning entry, “Building a Strong Foundation: How Leveraging Cross Collaboration Can Improve Standardization and Adoption of an eRegulatory Solution,” was written by Trisha Wise-Draper, MD, PhD; Justin Osborne; Benjamin Quast, MBA, CCRP; Emily Werff, all from the University of Cincinnati Cancer Institute, and Michael Hurley, MBA, of Complion.
New Case Study Offers Insight into an FDA Inspection from a Research Site using eRegulatory
If you find yourself standing on a railroad track, you can expect that at some point you’ll hear the distant whistle and rumble of an oncoming train. At that moment the smart decision is to step off the track in preparation of the train’s arrival.
For clinical research sites, FDA inspections are a bit like an oncoming train. They don’t whistle or rumble, but you know they are coming. You just don’t know exactly when. The difference between getting rolled over by the inspection and surviving unscathed comes down to preparation. What are you doing to step off the tracks?