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        • Mapper – Map and standardize without programming
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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 Management

Integrated clinical trial data management services from eClinical combine technology, process and experience for maximum efficiency and agility

Download Fact Sheet

Advancing Biometrics Services with elluminate

elluminate enables complete access to all clinical data sources, from across programs down to the patient level, compiling data from all data sources in a study and creating one single point of truth. Watch this video to learn how elluminate can put your clinical trials on the path to success with Data Central.

Your Partner for Program Level Data Strategy

eClinical clinical data management services blend technology efficiencies, process best practices, and experienced personnel to provide real time insights across all your collected data. Experienced and consultative data administration professionals support you in implementing a clinical data management plan that enables stakeholders to efficiently analyze and act upon your valuable trial data.

Tech-Enabled Clinical Data Management Services

eClinical Solutions data managers accelerate your timelines and help you produce the highest quality data through expert use of technologies including the elluminate® Clinical Data Cloud and the Medidata Rave Clinical Cloud™.

  • elluminate enables complete access of all data sources, from across programs down to the patient
  • All eClinical clinical trial data management services employ elluminate Data Central and Clinical Analytics
  • Accredited Medidata partner since 2008 with 9+ Medidata certifications

Agile Data Management

eClinical Solutions applies agile principles to clinical data management services through targeted and continuous data cleaning, proactive preparations for protocol changes, and skilled cross-functional collaboration. Clients gain a continuous stream of high quality clinical data readily available for safety and medical review, faster cycle times, and increased predictability.

  • Strategic data cleaning with centralized issue reporting, in-stream review, and SAE reconciliation
  • Expert knowledge and leverage of data standards, e.g., CDISC, CDASH and SDTM
  • Ongoing process and tech standardization means reusability efficiencies for your subsequent trials

An Experienced Data Management Partner

eClinical Solutions data managers average 10 years of clinical data management experience in life sciences. As a data-focused biometrics services provider, eClinical data managers know clinical data and the clinical development process inside and out and are prepared to consult on the best strategy for your program.

  • We view clinical data management as the cornerstone of your clinical development program
  • Skilled at collaborating with your other contracted service providers to meet objectives
  • eClinical Solutions data managers function as a seamless extension of your internal and external teams
Elizabeth Thompson
“

I can look at the bigger picture

eClinical data services using elluminate help me focus more on strategy and less on the piece by piece data review, so I can look at the bigger picture. eClinical also helps build better relationships within my company because I can provide the medical group and the safety group with what they need quickly and make sure that it’s accurate.

Elizabeth Thompson
Associate Director, Clinical Data Management
Sarepta Therapeutics

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

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

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

Learn more

David Evans | Assoc. Director, Data Management

Learn more

Clinical Data Management

Integrated clinical trial data management services from eClinical combine technology, process and experience for maximum efficiency and agility

Download Fact Sheet

Clinical Data Management

Integrated clinical trial data management services from eClinical combine technology, process and experience for maximum efficiency and agility

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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