SureClinical White Paper: Evaluating SharePoint-Based eTMF Apps – SterlingBio Smart CRO Services and Solutions

SureClinical White Paper: Evaluating SharePoint-Based eTMF Apps

Nearly fifteen years after its introduction, SharePoint is showing its age. User surveys and reports suggest that SharePoint 2013 is not cloud ready, is hard to use and lacks out of the box FDA 21 CFR Part 11 compliance validation when used in clinical trials.

Rancho Cordova, CA   January 27, 2014 SureClinical announced today the publication of their newest white paper, Evaluating SharePoint-based eTMF applications.  The white paper provides a comparison of Microsoft® SharePoint® based eTMF applications and collaborative cloud portals with integrated multi-organization digital signing capabilities.
Nearly fifteen years after the first introduction of Microsoft SharePoint, SharePoint user surveys and articles seem increasingly negative toward the usability and actual user adoption of SharePoint-based solutions. According to multiple publications, researchers, and online sources, SharePoint’s most cited customer complaints target its user interface, limited functionality, costly and time consuming software maintenance, support and integration issues. Microsoft itself makes no claims that SharePoint is FDA 21 CFR Part 11 compliant, in the cloud or on-premises. As a result of SharePoint’s apparent inability to meet user needs as well as a lack of published support for out of the box FDA Part 11 compliance validation, BioPharma should be fully aware of the potential usability, compliance and security issues when considering SharePoint as an eClinical application platform in pharmaceutical clinical trials.

Forrester Survey Shows Majority of Users Don’t Like SharePoint and are Not Adopting It

A Forrester Research survey report found that SharePoint is struggling to transition customers to its new cloud architecture. Despite its widespread distribution in enterprises, it appears that SharePoint users are expressing growing frustration. Noted market research firm Forrester Research conducted a SharePoint 2013 user survey and reported that an overwhelming majority of customers struggle with SharePoint’s Cloud and Mobile capabilities and 64% of organizations are not seeing the level of adoption expected, while 62% of users surveyed don’t like the SharePoint experience.

Widespread User Dissatisfaction Drives Users to Seek SharePoint Antidote

Even as a large number of articles and online comments hint that Microsoft SharePoint 2013 appears to be entering its twilight, user’s frustration with the platform may have reached a critical level.  According to Huffington Post, SharePoint users feel a ‘deep-seated disgust’ for SharePoint.  Although one could easily dismiss the Huffington Post’s comment as pure opinion, other fact-based media outlets such as ZDNet, PCWorld, CIO World, AIIM and more question SharePoint’s future, especially its ability to transition from an on-premises software application to a collaborative cloud application platform for use by organization collaboration beyond the corporate firewall.  Adding to the growing din of online user dissatisfaction comments is the claim that due to SharePoint’s frustrating user interface and lack of features, users often secretly revert back to email for file sharing and collaboration, says Nick Gamiano in a July 2013 posting at “SharePoint user surveys point to an aging architecture that no longer meets enterprise user needs,” said Zachariah Schmidt, CEO of SureClinical and author of the white paper, ‘Evaluating SharePoint-based eTMF Applications.’ “While Microsoft has some excellent office applications, as far as SharePoint goes we think it’s time for organizations to retire SharePoint as a platform for clinical trial applications and to move up to the next generation of content management for health sciences: collaborative cloud solutions that run on an easy to use, flexible, standards-based architecture that’s FDA Part 11 and HIPAA compliant.”

SureClinical eTMF Collaborative Cloud Platform with Mobile Digital Signing – The SharePoint Antidote

SureClinical eTMF is a collaborative cloud platform that provides clinical trial organizations with immediate time to value. With SureClinical’s advanced open cloud architectures, technology standards support, paperless clinical trial study enrollment, all running in a cloud-based FDA 21 CFR Part 11 solution, BioPharma organizations can streamline clinical trial operations and accelerate time to market.

SureEsign – Cloud-based Mobile Digital Signing Technology

As the only FDA compliance validated eTMF solution to provide paperless content completion in the cloud for organizations outside the corporate firewall, sponsors and CRO’s can enroll investigators in studies in seconds through a simple to use mobile-ready web portal.  Incorporating a simple to use PDF document viewer with patent-pending integrated digital signing with multi-factor authentication, SureClinical’s mobile web client with SureEsign is almost like having a pocketable digital notary. It runs on most smartphones and enables verifiable digital document signing and content completion at the point of origin, providing paperless content completion and collaboration across clinical research organizations, sponsors, investigators and clinical trial stakeholders. Per FDA Part 11 requirements, all digital signing transactions are tracked in a non-modifiable audit trail. The SureEsign solution is the only digital content signing solution for health sciences that works beyond the corporate firewall on mobile web devices, enabling clinical trial study investigator enrollment in days, not weeks.


ZDNet, “SharePoint: Can it navigate the cloud, mobile curves ahead?”, PCWorld, “Microsoft SharePoint faces a challenging future: Forrester,” Feb 2013, CiteWorld, “How did SharePoint become the poster child for bad enterprise software?,” Jan 2013 CIO Insight, “The Problems With Microsoft SharePoint,” March 2013, Forrester Research, “SharePoint Enters Its Awkward Teenage Years”, October 2013,

About SureClinical

SureClinical provides cloud-based health science applications that automate business processes and eliminate paper. SureClinical’s Certified Cloud includes integrated document completion, Esigning and archiving for networks of health science organizations that wish to share documents in an automated, regulated cloud environment. SureClinical’s applications run on Android®, Apple® iPad, Apple® IOS, and other popular smartphone platforms, as well as on all major web browsers such as Microsoft® Internet Explorer®, Google® Chrome® and others.  For more information, visit Copyright © 2014 SureClinical. All rights reserved. SureClinical, SureEsign, SureTrial, Certified Cloud, SurePortal, and the SureTrial logo are trademarks of SureClinical. Microsoft®, SharePoint® are trademarks of Microsoft.  Other names used herein may be trademarks of their respective owners.