SOURCE: Clinical Ink

Clinical Ink

July 09, 2015 13:30 ET

Clinical Ink Unveils SureSource® 5.9 for Remote Monitoring

SureSource 5.9 Establishes a New Standard for eSource and Risk-Based Monitoring by Simplifying the Remote Monitoring of Both DOCUMENTS and DATA

PHILADELPHIA, PA and CAMBRIDGE, MA and WINSTON-SALEM, NC--(Marketwired - Jul 9, 2015) - Clinical Ink, the pioneering provider of purpose-built eSource and patient engagement solutions for clinical development, today announced SureSource 5.9 and the immediate availability of new enhancements and functionality that dramatically improves the ability for sponsors and sites to effectively collaborate to remotely monitoring eSource Documents and Data. Among the key enhancements provided by SureSource 5.9 are a refreshed user interface to simplify navigation, dynamic user-defined reporting, dual-document comparison features, and intuitive access to eSource documents and data.

"We're constantly improving the SureSource platform to more fully realize the potential of eSource as a truly paper-less model for conducting clinical trials," said Ed Seguine, CEO, Clinical Ink. "SureSource 5.9 is a direct reflection of this commitment as we've incorporated feedback from hundreds of users to redesign our portal to dramatically improve remote monitoring in a way that reduces the burden for both sponsors, CROs and sites."

In contrast to EDC which focuses only on case-report form data entered days or weeks after the patient visit, Clinical Ink's SureSource 5.9 web portal is designed to permit real-time monitoring of both DOCUMENTS and DATA -- a critical necessity to ensure the integrity of the study. Every new feature is intended to enhance remote monitoring by making documents more accessible, data changes more transparent, and system metrics and reporting more relevant and dynamic. Key enhancements include:

  • Customizable Dashboards: Metrics dashboards can be configured to display over 50 user-defined data types. Data can be filtered and searched by multiple criteria to specifically identify trends, changes, and activity.
  • Document Comparisons: Compare any two eSource documents in a subject chart side-by-side to identify data discrepancies and review handwritten notes/comments. Multiple versions of the same form can be viewed simultaneously to identify what's changed between versions.
  • Changed Data: View all changed data at both the form and subject level for a more complete audit trail; easily identify what's changed since the last monitoring review; identify "new" data as it's entered. System activity is tracked separately and can be used to identify specific actions/events by subject, user, activity type, and date range.
  • Form Review: Form review comments are saved and easily visible to other monitors. "Jump-to" page functionality makes it easy to identify queries and open validations directly in the forms.
  • Standard/Custom Reporting: Convenient, direct access to standard and study-specific custom reports directly via the SureSource web portal.

Clinical Ink's SureSource platform captures eSource documents electronically via tablets used during the patient visit. Capturing data during the patient visit eliminates the need to perform source data verification (SDV) and permits real-time, remote access to source documents and data via the SureSource web portal. The U.S. Food and Drug Administration promotes and encourages eSource data capture and risk-based monitoring to improve the safety and efficiency of clinical trials.

About Clinical Ink
Founded in 2007, Clinical Ink is dedicated to transforming clinical development -- from Start to Submit™ -- by creating a completely paperless clinical trial platform for sites and patients. Clinical Ink's SureSource platform is purpose-built to capture source data and documents electronically at the site, while the CentrosHealth patient engagement platform provides patients with a variety of configurable apps to keep them informed, involved and compliant through the duration of a clinical trial. Clinical Ink maintains offices in Winston-Salem, NC; Philadelphia, PA and Cambridge, MA. Additional information is available at www.clinicalink.com or via 1-800-301-5033.

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