fda-inspections-need-not-be-stressful

Overcoming regulatory issues to expedite site activation

Complion CROs, Document Management, Research Trials, Sponsors, Uncategorized

fda-inspections-need-not-be-stressfulIf you’re a Sponsor or CRO, capturing and accessing the required regulatory information for an activation or ongoing study execution can be quite challenging.

The sites need to manage and maintain from a regulatory or ISF perspective what’s necessary to be reviewed by the sponsor. The information can be stored in multiple places, emails and portals. So, often the information gets lost, is hard to know if it’s the right version or if it’s even the right information.

In the case of master trials, these issues are further compounded. There are multiple sub studies that require rolling the information into the master trial review at the same centers and possibly as many as 10 different pharma partners at once. This is when the complexity of the regulatory process is even more apparent.

In master trials, there are multiple versions of key documents that need to exist — protocols, manuals, archives – and the site staff need to be trained and credentialed on that information. Ultimately, there’s a process that is being reviewed and ensured that everything is accurate and that the site has the right staff following the protocol effectively.

From a sponsor perspective, it’s essential to have insight into what’s actually happening. This isn’t just a collection problem to get access to these documents. There are real challenges in terms of study delays and additional costs when the information is incorrect; when the sites are running off of the wrong versions of documents; and when staff are not appropriately trained and credentialed to really be running on this study, especially within the master trial context.

It’s even more challenging as sites can be running any number of additional protocols to be able to enable them to start effectively and to make sure these issues aren’t coming up throughout the study as well.

Taking advantage of efficiencies

The solution: Not only ensure the site regulatory ISF information is reviewed and accurate, but also take advantage of efficiencies.

With master trials, the same site is used. That site is given multiple sub-study opportunities for the patients where there’s some matching algorithm centrally based on the front-line diagnosis. Why not want simply replicate all the startup regulatory information which cuts across all the sub studies except for the protocol?

The concept: Using an eRegualtory document system like Complion to file all the startup information to the trial master files, automatically organizing where that information lands and how it lands. Just do it once, then let the automation carry it through the study and across the program.

Complion’s platform not only improves study execution but also helps provide complete oversight and accelerate site regulatory activation. In addition, our customers are pleased with the simplicity of having to only set up once, and re-use across all their studies.

The best part is sites do not need to do anything differently. Complion works across the entire ecosystem of all systems including improving metrics with multiple eTMFs and providing RBM/CTMS missing data.

In an episode of PharmaTalk Radio, Complion CEO Rick Arlow and Dr. Len Rosenberg of the Leukemia & Lymphoma Society (LLS), discuss their collaboration on a LLS master trial. Listen to learn how adopting Complion’s platform drastically improved site startup speed, reduced delays and optimized CRA productivity for LLS.

Be sure to download our Executive Summary to learn more about the cost containment and quality benefits of Complion.

Connect with a member of the Complion team to learn how we can help manage your complex master trials.