Increase quality, reduce operational costs, and fulfill oversight requirements.

The cost of site monitoring and document collection for clinical trial Sponsors and Contract Research Organizations (CROs) is rapidly increasing due to inconsistencies across site processes. The lack of visibility creates challenges for sites to adequately fulfill oversight requirements.

How To Achieve a “No Findings” FDA Inspection Utilizing Remote Site Access

Moving from established processes and protocols to remote, decentralized trials posed many challenges for CROs and Sponsors.

See how our client, Tekton Research, moved from paper to a “no findings” FDA inspection. Now that's audit-readiness!

Complion is successful at getting sites to adopt our eISF system because it's specifically built for them. Sponsors and CROs that work with sites using Complion see increased quality through accurate submissions, improved TMF quality, completeness, and timeliness. They also gain real-time access to all site files from one location with a single password.
By achieving site utilization, Sponsors and CROs achieve their goals of increased quality, cost containment, and enhanced oversight. Learn about other Sponsor and CRO benefits.
Fewer trips and hours

Remotely access research files across all sites from one location to improve the monitoring process and reduce the time necessary to be on site.

Ready for an inspection

Improve inspection readiness by providing your sites with an easy-to-use system to centrally store documents to prove collection and ensure completeness.

Compliant and productive sites

Sites meet FDA and GCP requirements of owning, controlling, and validating their own file system. Everything is managed electronically within one system without original paper copies or wet-ink signatures.

Connected to site files

Sponsors, CROs, and Sites can view archived documents and export them when they're needed for trial master file teams. Multi-site access allows documents filed at one site to be instantly accessible at another site.

What Customers Say

“I wish that I had the power to choose your services [Complion] for my sites. I am a sponsor monitor. I was discussing your services with another CRA and we were singing your praises, especially during this crisis [COVID-19 pandemic]. I wish more of my sites used Complion!”Anonymous CRA
“I love that you can filter for dates and search document names! A lot of eReg Files provided to me do not have these features and are not in alphabetical order, so typically take twice the time to review. Complion is a GREAT tool and I wish more institutions used this eReg system."Anonymous CRA

Let's explore the opportunities together.

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