New York, NY (February 2, 2010) – Clinilabs is pleased to announce the release of Clinical InSite™, a document management solution for clinical trials that significantly reduces the cost of information management, and that provides novel workflow options that cut the cost of clinical monitoring and auditing.
Keeping track of all the clinical trial documents required by the US Food and Drug Administration (FDA) can be a challenging, time consuming, and costly endeavor for industry. Due to the volume of documents involved in regulatory submissions, most pharma companies now employ electronic systems to help them manage workflow. These systems must be compliant with Part 11 of Title 21 of the US Code of Federal Regulations (21 CFR Part 11). Federal regulations address matters such as validation requirements for computer systems, audit trails, electronic signatures, and system access authorization. While today’s electronic systems have delivered compliant solutions to pharma, these solutions are large, expensive, and difficult to maintain.
Clinical InSite™, developed on Microsoft Office SharePoint Server 2007, is a compliant document management application that enables us to capture electronic files of any kind, store them in a central-location in customized file formats, and make them accessible to remote users in real time. Our ASP model enables pharma clients to deploy the system with little start-up time, at a cost that is a fraction of systems with similar features. Users store all study documents (e.g., protocols, amendments, meeting minutes, lab results, tables, figures, etc…) in one filing system that can be remotely accessed by all members of a study team, with change control, audit trail, polling, and electronic signature features – all for a few dollars per day.
One important feature of Clinical InSite™ is the “fax or scan” data entry feature that allows users to fax or scan paper documents into the system. These documents become electronic images that are stored in customized file structures. Once stored, they can be accessed in real time by remote users. A novel use of this feature involves faxing or scanning patient source documents into the system, where they are placed in folders according to investigator site, patient number, and visit number. This allows a clinical monitor to open visit-specific files and compare source documents against case report form (CRF) data from a remote location. In studies performed to date, this workflow model has reduced the need for on-site monitoring visits by approximately 50%, and has substantially lowered the cost of clinical monitoring.
According to Dr. Amy McCoy, Associate Director of Data Services at Clinilabs, “We have deployed Clinical InSite™ for use in multicenter trials sponsored by big pharma companies, and the response has been tremendous. Applications that improve workflow simply enable study teams to work more efficiently, and that is the kind of time and money saving advantage we offer.”
“By leveraging Microsoft technologies as the foundation for new document management solutions like Clinical InSite™, contract research organizations can deliver more streamlined workflows and enable more efficient clinical trial processes, thereby playing a critical role in reducing the time and cost of drug development,” said Michael Naimoli, director of life sciences industry solutions, Microsoft.
To schedule a Web-based demonstration of Clinical InSite™, please e-mail us at info@clinilabs.com.
About Clinilabs Inc.
Clinilabs is a contract research organization (CRO) that provides early phase and specialty clinical drug development services to industry. Our organization offers clients a turn-key solution for single center and multicenter Phase I and II clinical trials. We also offer specialty drug development services in a variety of therapeutic areas. For more information, please visit www.clinilabs.com.
