E-REGULATORY

Cloud based, compliant, electronic regulatory and document management

Complion’s cloud based platform is the accepted standard for regulatory and document management. Specifically built for research sites, Complion increases efficiency, saves time, and provides more compliance than traditional, paper based systems. 
21 CFR Part 11 Compliant

Fewer trips and hours

 Remotely accessing site research files improves the monitoring process and reduces the time necessary to be on site.

Compliant, productive sites

Complion enables sites to meet the FDA and GCP requirements of owning, controlling and validating their own file system. Your sites can now manage everything electronically within one system without any original paper copies or wet-ink signatures.

21 CFR Part 11 Compliant

Complion is 100% Part 11 compliant and meets ICH GCP. Unlike a shared drive, CTMS or sponsor portal, it allows you to control and maintain your documentation entirely electronically.

Ready for an inspection

  • Organize your documents and search files easier

  • Standardize "binders" template or create folders on the fly

  • Track all documents and user actions in an automatic audit trail

Connected to site files

Both the sites and the sponsor can view archived documents on the platform and export the documents as needed so that they can be provided to trial master file teams.

CLINICAL RESEARCH

For Yourself  |  For Future Generations

COVID-19

Due to COVID-19 outbreak - learn more about what we are doing to help

Our Story

Optimed Research was founded by Donald McNeil, MD in 1999 as a stand alone research site focused on Allergy and Immunology. Overtime, we have grown to a network of affiliated sites all over the country. Our focus now is helping, often naive, physicians conduct research. We use advanced cloud-based technology to help manage every aspect of a trial. This strategic relationship allows the Investigator to focus on providing the clinical oversight, while we in turn can focus on the administrative and regulatory responsibilities. Together we are able to provide better oversight while reducing the cost and burden research can have on a practice.  

8080 RAVINES EDGE COURT STE 200  COLUMBUS, OHIO 43235 |  
P: 614.430.3030  |  F: 614.430.8025  |  RESEARCH@OPTIMED.US.COM