Harnessing technology and cross-functional alignment to enable successful statistical partnerships
Blog
Cross-functional alignment across the data life cycle enhances quality
With decades of experience and exposure to a range of study types, we provide proactive statistical input across the entire data lifecycle and deliver high quality outcomes, efficiently.
Adept at handling trial complexity and growing external data
Our team has extensive experience supporting the statistical requirements for complex trials including adaptive designs, master protocols, and basket trials, with particular expertise in oncology and rare disease indications.
Efficiency and standardization empowered by technology
Our biometrics team has adopted the elluminate Clinical Data Cloud®, including its Statistical Computing environment. The technology infrastructure enhances data access and speed of analysis while optimizing standardization and traceability.
Simplified clinical data standardization and conversion
We streamline conversion of both ongoing and legacy data to sponsor-specific standards in compliance with CDISC standards for clinical trials, from CDASH to submission using SDTM and analysis using ADaM.
Biostatistics and Programming Services:
- Input on study objectives, endpoints, sample size, stratification and randomization
- Development of statistical analysis plans (SAP) and analysis, development of tables, listings, and figures (TLFs)
- 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)
- Development of CDISC compliant datasets (STDM, ADaM)
- Submission-ready data services (STDM, ADaM, OpenCDISC, Define.xml)
See Other Services
Clinical Data Management
Integrated data strategy and real-time insights
Clinical Data Aquisition
Streamlined data capture solutions for complex trials
Functional Service Provider
Agile functional service outsourcing to navigate data complexity
FAQs
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. We generate SDTM-annotated CRFs compliant with CDISC guidance and FDA requirements, as well as SDTM and ADaM Reviewer’s Guides accompanying submissions. Our team leverages the elluminate Clinical Data Cloud and elluminate SCE to increase efficiency and traceability.
What expertise do you have in supporting complex and innovative trials?
Reflecting the research interests of trial sponsors, eClinical Solutions project teams have extensive experience supporting the clinical data requirements for complex trials including adaptive designs, master protocols, basket trials, and umbrella trials. Leveraging elluminate, artificial intelligence and machine learning, and applying external data best practices and risk-based strategies, enables the biometrics team to successfully navigate trial and data complexity.
What therapeutic areas do you have experience in?
eClinical Solutions is experienced across a wide range of therapeutic areas including but not limited to oncology, rare diseases, cardiovascular, dermatology, gastroenterology, gene therapy, hematology, immunology, infectious diseases, respiratory, vaccines, musculo-skeletal and central nervous system.