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        One platform for data from ingestion to insights

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        • Mapper – Map and standardize without programming
        • Data Central – Integrated data review and management
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      • Clinical Biometrics Services

        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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Functional Service Provider

Flexible and scalable solutions extend your team and support your unique functional needs

Download Fact Sheet

Functional Service Provider

Flexible and scalable solutions extend your team and support your unique functional needs

Download Fact Sheet

Reduce resourcing burdens and increase quality with an FSP for your clinical trials

The flexible eClinical Solutions Functional Service Provider (FSP) model offers an expert team of dedicated clinical data management professionals who are an extension of the sponsor — maximizing quality and scalability while reducing costs.

Your Experienced Partner for Program-Level Data Strategy

With eClinical Solutions you gain an FSP team of proven industry leaders who are experts in clinical data management and the Medidata Cloud and have a demonstrated track record of success. Our approach provides program level efficiencies, helping you implement a true data strategy that includes standardization and governance of processes and workflows.

  • Powered by elluminate and Medidata Rave Clinical Cloud to deliver best-in-class technology enabled services
  • elluminate enabled data services increase automation and quality of client deliverables 
  • Extensive experience in the design and build of client data standards, SOPs and libraries

Gain Resourcing Flexibility While Reducing Operational Costs

In addition to our dedicated experienced DM group, eCS offers flexibility for your fluctuating clinical development and resourcing needs. Our dedicated recruiting function specializes in the identification and recruitment of highly skilled life sciences resources so that we can provide your organization with true scalability. Gain security knowing that highly experienced resources will be available if your needs change suddenly.  

  • A proactive, consultative approach targets passive candidates
  • Structured interviewing and behavioral assessments ensure fit
  • Top talent is identified and project teams are built, onboarded and trained to client specifications

Strengthen biometrics capabilities from acquisition to insight

Functional Service Provider models realize value across clinical data management, biostatistics, and statistical programming activities.

Through our Study Build FSP,  eClinical Solutions’ clinical data acquisition experts apply deep knowledge of the Medidata Clinical Cloud to standardize the design and execution of electronic data capture (EDC) implementations 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

FAQs

What are Technology Enabled Clinical Biometrics Services? ​

eClinical Solutions data 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 Data Services clients?

elluminate is utilized in all data 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 data services 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 Data Services provider that is dedicated to the Medidata Rave platform with 9+ Medidata certifications and 11+ 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

View client
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

View client
bluebird bio

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

View client
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

Related content

Study Build FSP (Functional Service Provider) Fact Sheet

Learn more

Driving Quality and Speed in Clinical Data Acquisition

Learn more

Clinical Data Trends, Challenges, and Opportunities

Learn more

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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  • Clinical Data Acquisition
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  • Data Conversion and Standardization
  • Biostatistics and Statistical Programming
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