In previous e-feasibility-focused blog posts titled Maximizing Efficiencies in Site Enrollment I and II, we discussed how technology provides the opportunity to overcome specific site feasibility challenges. Web-based survey tools can be extremely beneficial to pharmaceutical companies and CROs for reducing site selection cycle time as well as operational costs (not to mention the opportunity costs). But what sets site feasibility, and other clinical forms, apart from other nonclinical survey types?
Before we answer that question, a quick anecdote: Once, when I was plagued with an ear infection, my primary care physician insisted I see an ENT specialist. While a longer drive and higher co-pay weren’t helping his case, he persisted, so I gave in and got the care necessary to manage my health. Better sense prevailed!
The point of that anecdotal detour is that, much like seeing the properly specialized medical professional, the health of your clinical processes are impacted by choosing the right specialized solutions. In the case of clinical trials, “health” can amount to costs of millions of dollars.
With a market full of well-known survey tools, why do clinical trials need something else? Here are five compelling reasons:
Confidentiality Disclosure Agreements (CDAs)
CDAs are an integral part of the site selection process. Sponsors need to maintain the confidentiality of protocols being shared with the sites. More often than not, they want the CDAs duly executed and accepted before sharing any details with sites. Millions, even billions, of investment dollars are at stake. What complicates the process is the different workflows and steps for executing these CDAs. Off-the-shelf online survey tools fall short of this specific requirement.
Surprisingly, a lot of sponsors and CROs are still using the traditional methods of sending out surveys: paper formats or email attachments. Often the sites respond with corrections to be made to their initial responses. It is not uncommon for sites to print out surveys and respond over mail. The sponsors and CROs then use these updated responses as appendixes to the initial response and file them for future reference. This gets messy if not specifically accounted for in the workflow. A site feasibility survey solution should not only maintain an audit trail for any updates to the responses, but also document the reason for such updates, while notifying the sites of any changes.
Monitoring Visit Reports
A critical activity during clinical trials is the regular monitoring visits conducted by the CRAs. The purpose of these visits is not just to collect data and essential documents, but to check process adherence. Some follow-up visits may be required, as subsequent visits are used to monitor adherence to anything actionable identified in previous visits. Eventually, a relationship is built between the CRAs and sites, which is extremely crucial for the success of the trial, as CRAs are the bridge between the sites and sponsor. It becomes extremely important for CRAs to have a dedicated portal to refer to previous visit reports and get a snapshot of the upcoming visits to better prepare.
Integration with eTMF and Regulatory Binders
Per the industry practice, all forms and surveys have to be archived for future reference. This archiving was traditionally accomplished by printing out the forms and adding them to the stacks of files. It goes without saying expectations have changed. Ideally, all site feasibility forms and monitoring visit reports should be integrated with the eTMF and regulatory binders, where these reports are automatically pushed to the specific electronic site folders. This not only makes the process extremely efficient, but also saves hundreds of hours in manually archiving and retrieving the information as required.
21 CFR Part 11, Annex 11, ERES, GxP, and GDPR Compliance
Last but not least, it is important that all processes and tools used in clinical trials are compliant with current and emerging regulations. In the event of an audit or inspection, nonclinical survey technologies fall short of meeting the required regulatory standards. It is imperative to not only meet these requirements, but also validate accordingly per FDA guidelines.
To discuss your site feasibility or e-clinical needs, contact us or visit us at https://www.trialinteractive.com/e-feasibility.