eClinical Solutions Unveils Innovative Clinical Data Repository (eGrex) to Enable Life Sciences Organizations to Take Control of Their Own Data
Leading Clinical Data Solutions Company Launches Cost-Effective Software Platform for Easy Access and Analysis of Clinical Trial Data
WAKEFIELD, Mass.–(BUSINESS WIRE)–BioPharma sponsors continue to rely upon an increasing number of contract research organizations (CROs) and eClinical technologies to support the research of drugs and devices. Controlled access to clinical data throughout the course of trials has become more critical and more challenging than ever. To address these challenges and resulting demands for clinical research executives to view data from all trials – at any time, in one format and in one place, eClinical Solutions released version 4.0 of its Clinical Data Repository (CDR) solution, eGrex.
In any given clinical trial, sponsors share data with multiple CROs and manage data from several sources, in diverse formats (i.e. ePRO, Labs, EDC, IXRS, legacy data, etc). At the same time, shrinking pipelines, growing financial and investor pressures and increasing regulatory demands make visibility and analysis of clinical data even more vital; therefore, clinical development and operations teams are in need of more “self-serve” tools that put data at their fingertips.
“With sponsors under increasing pressure from the FDA to standardize submissions for new drug or device approval, they need an easy and cost-effective way to collect, store, access and report on clinical data,” said Jeff Rogers, executive vice president, eClinical Solutions. “Fueled by the proliferation of clinical research technologies used in any given trial, as well as the growing acceptance of CDISC standards, eGrex will serve as the central core of clinical data coming from any source, enabling sponsors to take a holistic view of their pipeline, proactively identify potential challenges and better prepare for FDA submission.”
Other software solutions aim to serve as a “hub” of clinical data and are costly and cumbersome to both implement and sustain. eClinical Solutions designed its Web-based CDR, eGrex, to be deployed in as little as three months and is available at a fraction of the cost of these other systems.
eClinical Solutions beta tested eGrex with its customers, who found the key modules and features to be:
- Data Uploader – allows the extract, transformation, loading of (ETL) data from different systems and disparate formats; easily inputs information from any other eClinical technology and formats it for access/review in the CDR
- Data Downloader – delivers standardized data to multiple systems in different formats
- Reporter – generates reports within a trial and across trials
- Metadata Repository – manages and utilizes metadata from the entire clinical data lifecycle
- Business Intelligence – provides data analysis, visualization and ad-hoc reporting; JReview as a back-end platform enables sponsors to pull the CDR into dashboards and view the data in the same format as it will be submitted to the FDA for approval
- Administration and Security – enables sponsors to control access to various parts of any trial, and confirm authorized internal and external users including investors
- Running reviewable activity log – tracks data coming in and out of the system by user with timestamps and audit trails
“We’ve worked with multiple sponsors who are as passionate as we are about taking a strategic approach to planning, understanding and evaluating their data, but without easy, consistent and ongoing access to that information, their hands – and ours – often would be tied,” said Susan Bornstein, executive vice president, eClinical Solutions. “Based on feedback from our customers, we designed the CDR as the technology that will not only offer an alternative to those sponsors challenged by the ability to easily access and store data, but also will power our continued commitment to the strategic management of data.”
About eClinical Solutions
eClinical Solutions, a division of Eliassen Group, is a leading provider of clinical data solutions that has established a strategic approach by leveraging the latest technology for collecting, standardizing and managing clinical trial data. Our most recently launched version of our Clinical Data Repository, eGrex, is paving the way for life sciences organizations to apply CDISC standards, as well as aggregate and leverage data in various formats from multiple sources using a self-service approach. Additional services include reporting, training, data mapping, data integrations and Rave EDC study builds.
