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        Expert biometrics services accelerated by people and technology

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        • Clinical Data Acquisition – Design and implementation for innovative trials
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        • Urovant Integrated Summary of Safety (ISS) Case Study – Urovant streamlines ISS submission prep and planning with eClinical Solutions’ biostatistics and statistical programming services and elluminate
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Clinical Data Acquisition

eClinical clinical data acquisition services combine powerful technology with experienced EDC developers and data managers who know clinical trials

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Design and implementation for your most innovative trials

Data capture – it’s not just about EDC anymore. With the majority of today’s data volume coming from outside traditional EDC, you need data services resources who know innovative and integrated study design, including ePRO/eCOA, IVR, eSource, etc. Our approach combines technology and clinical development expertise to guide life science companies through the optimal design, implementation, and use of all your data capture systems.

Clinical Data Acquisition Approach

You don’t need to be an expert in every system  – eCS clinical data acquisition teams design data capture systems across functional perspectives to ensure it works for the end user. Studies are prepped for faster submission by designing with the end in mind. Gain unrivaled support from start to finish—from full design, build and implementation to incorporating data standards and building global libraries.

  • Systems configuration and study builds leveraging the entire Rave suite
  • All studies built to conform with CDASH and SDTM standards
  • Quality approach incorporates early input from expert data managers and biostaticians

Medidata Rave Fanatics

An 11+ year Medidata partner, eClinical Solutions supports life sciences organizations with trusted expertise in the industry leading Medidata Rave Clinical Cloud™ platform. eCS clinical data acquisition teams are uniquely qualified to configure Rave data collection designs, standards and libraries.

  • 11+ Year Accredited Medidata Service Partner
  • Industry experts in leveraging Rave products for data collection
  • Experience delivering over 500 Medidata technology projects

Proactive Partnership for Study Builds

eClinical Solutions delivers its Clinical Data Acquisition services through study-based and functional service provider (FSP) models. Applying unparalleled knowledge of the Medidata Clinical Cloud, through the Study Build FSP, our experts seamlessly handle the design and execution of electronic data capture (EDC) implementation across your clinical trial portfolio.  Efficiency gains include up to 60% timeline savings against the industry average for study start-up after multiple builds.

Learn more about the Study Build FSP

95%

repeat business rate

30%

time and cost efficiencies on subsequent trials

10

eCS Data Mgrs average years of experience

11+ Yr

Accredited Medidata Partner

9+

Medidata certifications

500+

Medidata projects delivered

FAQs

What are Tech-enabled Biometrics Services?

eClinical’s biometrics services teams accelerate your timelines and help you produce the highest quality data through expert use of technologies including the eClinical Solutions core platform, the elluminate® Clinical Data Cloud, and Medidata’s Rave Clinical Cloud™.

What type of Biostatistics and Statistical Programming Services do you offer?

eClinical Solutions biostatisticians and statistical programmers 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. Services include developing mapping methodologies, organizing content into a structure aligned to submission requirements, and facilitating incorporation into the submission, mapping data into clinical data repositories. eClinical Solutions statistical programmers bring CDISC standards expertise and in-depth knowledge and experience in producing FDA compliant datasets and TLFs towards submission. Generate SDTM-annotated CRFs compliant with CDISC guidance and FDA requirements, as well as SDTM and ADaM Reviewer’s Guides accompanying submissions. 

What is the benefit of working with a data-focused Services Provider vs. a full service CRO?

Our philosophy and model is for sponsors to identify the best in breed CROs to meet the specific needs of each trial. Clinical data management should be the consistent cornerstone of the development program to ensure efficiencies are realized (both time and money) from trial to trial. Our entire focus is on sponsor data with our mission to make clinical data acquisition and analysis easy and intelligent to help bring new treatments to patients faster. This focus and commitment to your clinical data allows us to be efficient, have proven expertise and provide a consultative approach to ensure your data meets your development requirements.

What benefits does elluminate provide for Biometrics Services clients?

elluminate is utilized in all biometrics services projects to provide advantages such as data integration and centralized access, standardization using elluminate Mapper, and real-time data review and visualization with Data Central and Clinical Analytics. elluminate gives both our clients and Data Managers complete transparency into the data during trial conduct and beyond, without the need for time-consuming and costly programming. You and your eClinical Solutions team are empowered to make quicker critical decisions with powerful visualization and advanced analytical intelligence for all your clinical data from any source, in a standardized format.

What therapeutic areas do you have experience in?

eClinical Solutions is experienced in many therapeutic areas including Cardiovascular, Endocrine and Metabolic, Gastroenterology, Hematology & Oncology, Immunology, Infectious Diseases, Rare Disease, Respiratory, Urology and Vaccine. eClinical Solutions project teams have extensive experience conducting complex trials such as oncology, rare disease and gene therapy. 

Do you only do study builds using the Rave Clinical Cloud?

eClinical Solutions was one of Medidata’s first accredited partners to support Rave, achieving Services accreditation in 2008 and Technology accreditation in 2012. eClinical Solutions is the only Medidata partner to commit to their platform, in that we will only perform Rave study builds. eClinical could support clinical data management activities leveraging other EDC systems, but we believe in having the deep expertise and experience needed to master study database configuration.

What is unique about your relationship with Medidata?

Sponsors working with Medidata & eClinical Solutions experience increased control over their clinical data through access to all trial data including legacy Rave studies across CROs and sources via elluminate. A real-time, tightly coupled integration between Rave & elluminate provides visibility, oversight, cost savings and control. eClinical is the only biometrics provider that is dedicated to the Medidata Rave platform with 8 Medidata certifications and 15+ years of partnership. You also gain maximum reuse of optimized data collection designs, standards and libraries through URL management/ownership for sponsors. 

Clients

Learn more about our clients...

From high-growth emerging biotechs to the largest life sciences companies in the world, learn how clients are partnering with eClinical Solutions to transform clinical research and drive real measurable results.

Bristol Myers Squibb

BMS Adopts a New Clinical Data Architecture with elluminate

View client
Karyopharm

Karyopharm Achieves Clean Data Sets with eClinical's Biometrics Services

View client
Jounce Therapeutics

Jounce Enhances Clinical Operations & Oversight with elluminate

View client
Agios

Agios Produces Compliant & Submission-Worthy SDTM with elluminate

View client
Sarepta

Sarepta Accelerates Data Review for Rare Disease with eClinical's Biometrics Services

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Decibel Therapeutics

Decibel Maximizes Every Data Point with eClinical and elluminate

View client
WAVE Life Sciences

Wave Life Sciences Increases Data Visibility, Efficiency & Quality with eClinical's Biometrics Services

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bluebird bio

bluebird bio Maximizes ROI with Self-Service Data Integration and Visualizations

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TRIO

TRIO Powers Digital Transformation in Clinical Trials for Cancer

View client
Cerevel

Cerevel Designs and Implements a Modernized Data Ecosystem with elluminate

View client
Urovant Sciences

Urovant Streamlines ISS Submission Prep & Planning with eClinical and elluminate

View client

Resources

Recent content

Best Practices for Implementing New Technology and Facilitating Adoption

Learn more
PHUSE US Connect 2023

Build vs Buy for the SCE: Considerations for the Future of the Statistical Computing Environment

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David Evans | Assoc. Director, Data Management

Learn more

Clinical Data Acquisition

eClinical clinical data acquisition services combine powerful technology with experienced EDC developers and data managers who know clinical trials

Download Fact Sheet

Clinical Data Acquisition

eClinical clinical data acquisition services combine powerful technology with experienced EDC developers and data managers who know clinical trials

Download Fact Sheet

Ready to take charge of your clinical data?

Schedule a demo and/or speak to an eClinical Solutions representative to learn more.


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