Data Driven Services | Fact Sheet by eClinical Solutions

ARE YOU READY TO TAKE CONTROL?

For more than a decade, eClinical Solutions has been providing centralized data services for biopharma companies and CROs, allowing them to focus on clinical research. More than that, our powerful elluminate platform provides ready access to all your data, ®

REGAIN CONTROL With eClinical Solutions Data Services Driven by the elluminate® Platform

yielding rich insights that will keep your trials on track and ensure your success. Our experienced data professionals routinely help Sponsors and CROs to do much more than just meet their clinical trial objectives; they can also empower you by leveraging the elluminate® platform to provide centralized control and full transparency into your trials

and research programs. The platform gives you dozens of out-of-the-box analytics and visualizations for clinical data, clinical operations and risk-based approaches to trial conduct — right at your fingertips. You can also perform ad-hoc analysis quickly and easily with a few mouse clicks, and our data teams are there to support you whenever you need them.

eClinical Solutions Empower Program The Empower Program has enabled many sponsors and CROs to implement a robust data empowerment strategy that truly puts them in the driver’s seat for their clinical research programs. The benefits of the Empower Program include: Increased control over all their data streams and easy access to data, any time, anywhere Significant reduction in study start-up times Increasing compliance with FDA data requirements and industry standards

EXPERT DATA SERVICES AND POWERFUL TECHNOLOGY THAT PUT YOU IN THE DRIVER’S SEAT

Improved quality of eClinical study performance Simplified vendor management and expert support of a trusted partner Centralized control of one of your greatest assets – your clinical data.

Let us show you the power of elluminate® coupled with our expertise Schedule a demo at eClinicalSol.com. UNITED STATES

INDIA

508.337.4230 603 West Street Mansfield, MA 02048

508.594.8075 1st Floor, CR1, Prestige Shanthinikethan, ITPL Road, Bangalore – 560048

ALL YOUR DATA RIGHT AT YOUR FINGERTIPS

Professional Data Services that Put You Back in Control Data, data everywhere, but can you access it? At eClinical Solutions, our mission is to put your data back in your hands. We do this by combining our proven elluminate® platform with our experienced team who are focused on and passionate about clinical research data.

D A T A S ER V I C ES

TE C HN O LO G Y

CLINICAL DATA ANALYTICS

DATA ACQUISITION

CLINICAL TRIAL OPERATIONS ANALYTICS

CLINICAL DATA MANAGEMENT

elluminate® makes data acquisition, aggregation, visualization and analysis fast and easy.

In fact, 95% of the clinical research teams who try our platform and expert data services come back again, many choosing to implement elluminate at an enterprise level. ®

RISK-BASED MONITORING

DATA CONVERSION AND STANDARDIZATION

Our data service professionals average more than 12 years working with clinical data. Our subject matter experts have deep experience in clinical data management, eClinical study building and optimization, data conversion and standardization and all aspects of biostatistical and statistical programming to make your data submission ready.

eLLUMINATE® MAPPER

BIOSTATISTICS AND STATISTICAL PROGRAMMING

DATA MANAGEMENT HUB

OVERVIEW OF PROFESSIONAL DATA SERVICES DATA ACQUISITION As a Medidata Center of Excellence, we regularly build and optimize complete eClinical studies using RAVE EDC, Coder, Balance RTSM, Patient Cloud and other Medidata tools. We ensure that you fully utilize your investment in the Medidata Clinical Cloud by leveraging and coordinating features across the entire suite.

Our expert teams use the power of the elluminate® Mapper module to rapidly aggregate and convert your data into CDISC-compliant data that is ready for viewing, analyzing and visualizing whenever you need it. Your data can then provide insights and analytics for clinical operations, risk-based monitoring and much more.

eClinical Solutions Quality Study Build Process

Database Go-Live User Acceptance Testing Internal System Testing Quality Control

Unit Testing

DATA CONVERSION / STANDARDIZATION

CLINICAL DATA MANAGEMENT

BIOSTATISTICAL SERVICES

4 WEEKS

Beginning at study start-up, we are focused on your data needs for all aspects of trial conduct through submission. Leveraging Data Science and elluminate® DM Hub, our timely data management and medical data review services proactively seek out anomalies and outliers to keep your study running smoothly and to maintain data of the highest quality.

Biostatisticians lead the way for all of your statistical needs, from authoring the Statistical Analysis Plan and preparing your Tables, Listings and Figures to providing ADaM deliverables and ISS/ISE submission packages.