eClinical Solutions
Biostatistics and Statistical Programming Services
eClinical Solutions’ comprehensive biostatistics and statistical programming services, backed by the power of elluminate, enable sponsors of all sizes to maximize the value of their clinical data. Our experienced team of biostatisticians and statistical programmers streamline data workflows and build proactive partnerships to help you confidently navigate the increasingly complex data landscape and reduce cycle times.
Our Value
Whether delivering value to sponsors through standalone biostatistics and programming services, or as part of eClinical Solutions’ wider biometrics offering our unique value proposition includes:
Empowered by Best-In-Class Technologies
Our biometrics team has adopted the elluminate Clinical Data Cloud, including its Statistical Computing environment. The best-in-class technology infrastructure enhances data access and speed of analysis while optimizing standardization and traceability. Through continual process improvements and incorporation of advanced analytics, our biostatisticians and programmers empower sponsors to make faster, better-informed decisions.
People Focus
A focus on talent development and equipping staff for a modernized clinical development landscape leads to strong employee engagement and knowledge retention for client projects. By harnessing technology to free team members from the burden of routine tasks, we enable greater strategic focus and promote innovation.
Close Alignment Across Biometrics Functions
Statistical input across the data lifecycle enables us to focus on the critical data that matters and deliver high quality outcomes, efficiently.
Experienced Team Equipped with the Right Skills for Modern Trials
Our biostatisticians and programmers bring decades of experience and exposure to a broad range of study types and scenarios. This deep cross-therapeutic knowledge leads to a consultative experience for clients, and a proactive approach as a virtual extension of internal teams.
Adept at Handling Increasing Complexity and Growing External Data
The clinical development environment is becoming increasingly complex, with adoption of decentralized and innovative trials, and a growing volume of external data. Our team brings together the right technology, processes, and people to deliver solutions that allow sponsors navigate the challenges and maximize the opportunities of the new data environment, including a Center of Excellence for External data dedicated to enhancing standardization across data types.
Flexible Models
We work with clients using a variety of models including statistical consultancy, study-based biometrics implementation, CDISC conversion and ISS/ISE support, and functional outsourcing.
Our Biostatistics and Statistical Programming Services Include:
■ 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)
■ Development of CDISC compliant datasets (STDM, ADaM)
■ Submission-ready data services (STDM, ADaM, OpenCDISC, Define.xml)
CREDENTIALS
50% of statistical programming team have a Master’s level of education or above
90% repeat business rate
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50% of biometrics team have experience with innovative trial designs
CDISC Platinum member
Our client needed to prepare a submission package within an ambitious timeline, involving the conversion of 17 legacy studies and integration of 6 studies using a complex pooling system. To meet these goals and be prepared for submission, the sponsor sought a biostatistics partner with a proven track record of submission experience, and the ability to deliver quality results on time. They selected eClinical Solutions, and our experienced biostatistics team created an efficient and successful process to support approval for the client’s product.
Recognition for Employee Well-Being and Employee Appreciation
eClinical Solutions’ Biometrics Services team offers end-to-end data solutions, from acquisition to insight, accelerated by elluminate. To book an exploratory discussion and learn how our team can help you to optimize clinical development, ensure regulatory compliance, and empower faster, better-informed decision-making get in touch:
For more information or to request a demonstration, visit us at: eclinicalsol.com
Or email us at: info@eclinicalsol.com