RegDocs365 offers a suite of solutions for regulated content and collaboration, specifically streamlined for life sciences. All of our products are built on our audit-ready, compliant-cloud (ARCC).
How It Started
RegDocs365 came about as a result of the collaboration between Court Square Group hosting a submission processing environment for eSubmissionSolutions. The founders, Keith Parent from Court Square Group and Antoinette Azevedo from eSubmissionSolutions had been working together for a number of years. Recognizing the significance of the environment that Antoinette was using for her client base we decided that this would be a great offering for small to mid-size companies looking to do their own Regulatory filings. By replicating the environment for other Regulatory customers we were able to have our first regulatory offerings featuring the DIA EDM and eTMF reference model.
Along the way another customer wanted to use the Qualified and validated RegDoc365 environment for gathering clinical trial data specifically from a unique trial that gathered voice recordings using commercial grade products. Our engineers designed a way to put a 21 CFR Part 11 wrapper around a number of commodity products to allow us to focus on the regulatory requirements and use proven technology solutions for data gathering. Since SharePoint is a great collaboration tool it provided a content management solution with an easy to use collaboration environment for CROs, Sponsors and Clinical Sites. We now have ways of collecting Voice, Video, Fax and regular documents into our clinical repositories. By incorporating other tools to facilitate content analysis we have allowed our customers to actually pull data out of their documents and aggregate that data for summary reports.
Along the way other customers have asked us to add extensions into the RegDocs365 environment so we extended it with tools such as Adlib’s Enterprise Engine for PDF Rendering solutions and FormPipe’s SOP, Quality and Training management solutions. We continue to work with our client base to make this the most functional environment while maintaining the regulatory compliance the our customers require.
Our Mission
Provide a Validated Content and Collaboration environment to enable our Life Science clients to concentrate on their Science while we concentrate on their clinical and regulatory needs. We want you to save the world while we save your data!!!
Life Science Start-up?
Learn more about LS Basic and LS Launch Pad, our fully compliant, audit-ready IT infrastructure solutions specifically made for start-ups of any size and in any round of funding.
CRO or Life Science Consultant?
Enable collaboration and content management for your clinical sites, Sponsors or CRO partners. Enable efficient collaboration and content sharing while maintaining regulatory compliance.
Regulatory Group?
Use our pre-configured DIA EDM or eTMF reference models and our templates to provide that out of the box capability that you would only see in more costly solutions.
