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        • Mapper – Map and standardize without programming
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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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Biostatistics and Statistical Programming

Strategic statistical input and programming to optimize your clinical development and ensure regulatory compliance

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Redefining the standards for data excellence

Comprehensive biostatistics and statistical programming services from eClinical Solutions offer expert analysis and customized data programs to fit your goals from study start to finish. Experienced professionals offer technical support for your most innovative and complex trials, working closely with clinical data management. End to end services and collaboration guarantee the efficiency and accuracy of your study.

Skilled Biostatisticians to Support Your Trial

eClinical biostatisticians provide strategic statistical input to your clinical trial protocols with respect to study design, ensuring optimized clinical development plans. In addition, you can rely on the eClinical expert biostatistics team to confirm adherence to industry standards and regulatory requirements.

  • Input on study objectives, endpoints, sample size, stratification and randomization
  • Development of statistical analysis plans (SAP) and analysis, development of tables, listings, and figures
  • eCRF design and review and statistical review of Clinical Study Reports (CSR)
  • Data and Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) support
  • Interim and final reporting, Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)

Experts to Address All Your Statistical Data Analysis and Programming Needs

The SAS programmers at eClinical Solutions have experience programming data listings, tables, and figures across all phases of clinical studies and therapeutic areas. eClinical employs robust internal processes to ensure industry best practices are implemented to support all levels of service. Quality control is achieved via automated checks and independent review according to dataset specifications or the SAP. QC steps are followed to ensure the highest level of quality in every phase of programming and data reporting.

  • Development of CDISC compliant datasets (STDM, ADaM)
  • TLF production and validation
  • Development of integrated ADaM datasets for ISS/ISE analyses
  • Submission-ready data services (STDM, ADaM, OpenCDISC, Define.xml)

FAQs

What are Technology 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. eCS 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. eCS 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. eCS 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 services 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 Biometrics Services

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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 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 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

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David Evans | Assoc. Director, Data Management

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Biostatistics and Statistical Programming

Strategic statistical input and programming to optimize your clinical development and ensure regulatory compliance

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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