Improve Communication and Collaboration Between Sites, Monitors and Sponsors
The NextDocs Clinical Documents Module, built on Microsoft SharePoint, provides an out-of-the-box solution for collaboration and document sharing between sponsors, investigators, site monitors and other parties.
Unlike traditional software systems that add layers of complexity to clinical processes, the NextDocs Clinical Documents Module is preconfigured for managing the entire set of typical clinical study documents and processes. That makes setting up each study both easier and faster. And with SharePoint’s familiar user interface and seamless integration with Microsoft Office, users readily adapt to the system.
The NextDocs Clinical Documents Module is part of the NextDocs Document Management System, which extends Microsoft SharePoint with a set of integrated features that fully address all the requirements of regulations such as 21 CFR Part 11. The result is a clinical document management solution that delivers better collaboration, more efficient collection of study data and lower costs.
The NextDocs Clinical Documents Module provides:
- Management of Essential Study Documents such as:
Investigator Brochure
Study Protocol and Amendments
Informed Consent Forms
Monitoring Reports
Recruitment advertisements
Study Agreements
Regulatory Authorization
Curriculum Vitae
Screening and enrollment logs
Case Report Forms
- Scheduling and tracking of site monitor visits
- Documentation of investigational products protocols
- Collaboration between vendors, sites and sponsors
- Complete document lifecycles from creation through review and approval
- Fully configurable visual workflow creation
- Support for all 21 CFR Part 11 and related regulatory requirements, including digital signatures
