When was this picture taken?
1987?
2002?
Wrong, it was taken just a few months ago at a client’s site. You can be assured that nobody was happy with this situation.
When clinical staff try to access the binders behind the boxes, leaving aside that they need binders at all, they must move these monstrosities around. They take up office space you pay for by the square foot. They represent possible fire hazards, staff back injuries and are simply unsightly. These boxes highlight the problem that Clinial.ly can solve for you.
FDA Regulations Provide for Electronic Records
It is worthwhile to go back in time to a few decades earlier to discuss why the boxes are there in the first place. In 1997 the FDA established the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. This provision is codified in CFR 21 Part 11. Subsequently, the FDA issued more guidance in 2003. The FDA clarified that it wants you, the clinical research site, to use electronic records. Yet many in the industry are not. There are many reasons for this. Many eReg systems out there are not intuitive, forcing the employee using them to spend time hunting around the interface for the tasks they want to accomplish. These systems are cumbersome, awkward to interact with and expensive on top of everything else. They don’t do a thorough job of solving the core problem, so you’re left with a mix of paper documents and electronic records. This is what you are trying to avoid in the first place!
We’re aiming to change all of that.
How much time do you spend on document filing, looking for documents, and cataloguing? When staff turns over, do the replacements spend valuable time figuring out where important regulatory documents are and why they were catalogued a certain way? When the IRB roster changes, as it regularly does, how many studies do you need to update with the new roster? Finally, how do you handle training logs for protocol updates? These tasks distract you from seeing patients, not to mention they’re prone to error. We’re only human. Our technology solves these exact problems while eliminating human error. Never worry about another study closeout – everything is catalogued, kept updated and issues are raised in real time.
Instead of chasing down signatures, your study coordinator could see more patients per day. Seeing more patients, as you know, leads to higher revenue for the site. This is possible as you’ll require fewer SCs for the same or an even greater patient flow. Instead of hunting for documents, your business manager will focus on bringing on new studies or speak to sponsors about enrolling additional patients for current studies. Your regulatory person may have been filing documents or looking for delegation logs, updated informed consent or investigator brochures. Instead, they can provide sponsors remote access, thereby giving them transparency into your well-run regulatory procedures and documents. They’ll know you are inspection-ready , and you know that your business is an efficiency machine.
The image above is a daily reminder for us why we are passionate about our mission. We hope it will be distant memory for our clients in the near future.
https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=ef2fab3ce5d7a2b907e657e985c40702&ty=HTML&h=L&mc=true&n=pt21.1.11&r=PART
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf