Site Management Solution
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.
Speed Study Activation
Compliant Site Files
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.
SureETMF Site Solution
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.
Digital Content Capture
Improve Regulatory Efficiency
Monitors can say goodbye to chasing wet signatures. With SureISF, you can eliminate the time-consuming manual content capture processes such as printing, scanning, signing, uploading, tagging, naming, and classifying. With SureISF, Sponsors can be confident that their sites can streamline those tasks with best in class Adobe digital certificate signing, automated PDF form and document completion workflows with collaborative portals, real-time content capture with automated tagging, saving time and enhancing quality.
Understand what you have and what you need
SureISF supports required document, expired document and missing document tracking and reporting. Simple to use dashboards and notifications allow collaboration between sites, sponsors, CRO’s and clinical trial stakeholders.
Collaborative Clinical Network
Share Content, Knowledge & Insight Globally
SureISF is the only eISF solution that provides access to a global trusted clinical network.
With SureETMF and SureNetwork, you have the ability to import centrally managed documents from SureNetwork’s Person or Org profiles into your ETMF. Get automated updates for the latest licenses, CVs, financial disclosures and more with one click on a person’s profile.
The Fastest Path to Success
Customers and Users
“I absolutely love SureEsign! Now I can complete and sign documents from my Apple iPhone anywhere!”
Emily SchlegelClinical Research Associate
“SureNetwork gives me the ability to share my profile and credentials once with multiple sponsors and CROs, instead of having to email it multiple times. It is a big time saver.”
Anna Schmilsky, M.D.Radiologist
“With SureClinical, we cut our clinical trial project startup time in half. Going digital was not only a significant time saver, but it also enhanced the quality of our data.”
“With SureClinical eTMF Cloud, internal and external study stakeholders can collaboratively complete, digitally sign and share regulatory and study information in the cloud from mobile or web. This strategic capability allows us to eliminate paper at point of origin, accelerating document completion and enhancing document quality.”
Lynda ShelleyExecutive Director of Clinical Operations, Novotech
”With SureClinical, our goals of going digital have been met. We tested and sandboxed many systems before making the decision to go with SureClinical for SureETMF and SureCTMS. Our own client users are passionate about the software and it is incredibly easy to initiate, file and manage documents and trials.”