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.
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.
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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?
“Uncontrolled variation is the enemy of quality.”
-- William Edwards Deming
The concept of standards is not new.
People throughout time, in all eras, geographies, and industries have looked to create standards as a way to improve efficiency and reduce variance of outcomes.
For instance, King Henry I of England standardized measurement in 1120 AD by instituting the ell, which was equivalent to the length of his arm. Another example is that the Egyptians were the first to develop the 365-day calendar and are often credited with logging 4236 BC as the first year in recorded history. In 2009, a cross-section of life science companies, contract research organizations, technical vendors, industry groups and others established the Trial Master File (TMF) Reference Model to develop a standardized taxonomy and nomenclature for organization of TMF content.
From Burden to Opportunity
Remote monitoring technology initiated by sponsors often inflicts additional burden on sites, requiring them to not only print and file their regulatory documents, but scan and upload them to multiple sponsor portals, too. However, sites are beginning to identify more efficient ways to enable remote monitoring. Empowered sites are taking control and initiating technology from their side to enhance collaboration with sponsors and streamline processes, ultimately lifting their day-to-day burden.
In summer months you can look down from one of the bridges spanning the Cuyahoga River here in Cleveland, Ohio to see rowing teams seated in slender rowing shells, slicing through the murky water. In each shell team members pull on their oars, propelling the sleek craft with remarkable speed and efficiency. Of course, that speed is possible only when everyone rows in cadence, and in the same direction.
That same level of coordination and integration is absolutely essential for the technologies on which clinical research organizations rely to manage regulatory and other essential trial information. Without that integration organizations can’t move forward, facing unnecessary duplication of effort, interrupted communication flow, and other costly, time-consuming obstacles.