Clinical Ink SureSource(R) Platform Expansion Uniquely Combines Central Monitoring and Data Management Capabilities

WINSTON-SALEM, NC and PHILADELPHIA, PA--(Marketwired - June 27, 2016) - Clinical Ink®, the leading provider of eSource, RBM, and patient engagement technologies for clinical trials, today announced the availability of a number of innovations to the SureSource platform. This latest release focuses on data management and centralized monitoring functionality and builds upon the unique capabilities of eSource to provide a better clinical trial experience for patients, sites, and sponsors.

"It is time to expect a better clinical trial experience for patients, sites, and sponsors," said Clinical Ink CEO, Ed Seguine. "The latest SureSource release markedly improves the experience for sponsors by explicitly linking data management review and centralized monitoring into a single platform with access to both documents and data. No other system provides such robust insight into what is actually happening at a site or with a patient because they aren't used at the critical moment when the data is initially captured. With SureSource, protocol violations are reduced, data is clean when entered and available immediately, and the time lag for monitoring and data management is measured in hours not months."

The SureSource platform eliminates the need for separate EDC, eCOA, and RBM technologies reducing the complexity, cost, and time required to implement and manage these processes. Capturing both documents and data at the source provides sponsors with insights into data quality, protocol execution, and compliance that would be impossible with legacy EDC/eCOA/ePRO systems and current monitoring practices.

The new capabilities introduced in the latest SureSource release include the following:

• Data Review: Review data domains with advanced filtering and display options; Create query groupings; Explicit linkage to original source documents
• Central Monitoring: Configure multiple review types (Safety, Medical, Rater); Compare multiple document types simultaneously (e.g. Medical History and linked ConMeds); Improved workflow and navigation
• eCOA Subject Mode: Permit site users and patients to share the same device for eCOA assessments; Role-based form permissions track site and patient activity
• Integrated Training: Single cross-study, cross-sponsor portal for all platform training; Automatically trigger training based on new functionality and 'refresh' timing

"The SureSource platform accelerates the convergence of the traditionally discrete functions of monitoring and data management," said Jonathan Andrus, Chief Data & Privacy Officer at Clinical Ink. "As important as the raw data is, it doesn't necessarily tell the whole story. The availability of the original source documents, which serve to guide the site in executing the protocol, provides an anchor point for both central monitoring and data review and enables unique insights to be gleaned."

Clinical Ink will present in the DIA Innovation Theater with DBMS Consulting on Monday, June 27 at 10:00am on the topic of "Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes", and on Wednesday, June 29 at 3:25pm about "Safety Data Delay is a Risk - Enhance Signal Detection with Customized MedDRA and Drug Grouping Queries".

Visit us at DIA Booth #1004 to see how SureSource is transforming the clinical trial experience! Share your challenges with existing EDC, eCOA, and ePRO technology integrations and multi-vendor service providers and register to win a Microsoft Surface Pro.

About Clinical Ink

Founded in 2007, Clinical Ink® is transforming clinical development with innovative technologies that make clinical research easier for sites, sponsors and patients. Clinical Ink's SureSource® platform directly captures eSource data and documents and improves patient engagement while streamlining clinical development. Clinical Ink maintains offices in Cambridge, MA, Winston-Salem, NC, and Philadelphia, PA. Find more at www.clinicalink.com.