Product Overview
Designed by and for Clinical Operations professionals, SureISF™ is a cloud-based regulatory content management application for Electronic Investigator Site Files (EISF). With FDA Part 11 compliance validation, SureISF automates the capture, digital completion, signing, classification and tagging of content. Designed to enable clinical sites to collaboratively view, share, digitally esign, comment on and manage site-specific content, SureISF is an easy to use solution for all your sites.
Simplify and streamline site content management tasks with SureISF.
- Sites can streamline reviews and approvals to speed study activation with SureISF.
- SureISF is provided with out of the box 21 CFR Part 11, EC Annex 11 and HIPAA compliance validation certification.
- Have confidence that your site solution is FDA and EC-compliant and get to the business of enrolling patients and starting your study sooner.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
SureISF is based on and is interoperable with SureETMF, SureClinical’s flagship cloud eTMF management solution. Major global CRO’s, Sponsors and research sites have standardized on SureETMF.
SureISF can be used for all clinical trials globally, with support for all popular Microsoft Office file formats, trusted Adobe Digital Certificate eSigning, with connectivity to popular cloud applications. With its HIPAA-compliant DICOM medical image support, SureISF and SureETMF provide clinical trial stakeholders with a value unavailable in any other iSF solution.
About the company
SterlingBio is a leading provider of cloud-native Eclinical Applications that are open, connected, smart and easy to use. Life science companies in Biotech, Pharma, Clinical Research, Medical Devices and Medical Research choose SureClinical to accelerate, streamline, and automate clinical trial and quality management processes everywhere. Our Eclinical Ecosystem empowers internal and external teams to break free from vendor lock-in by connecting applications, data and intelligence on our collaborative and compliant Eclinical Platform.
