Protocol Design

We provide expert protocol design services, ensuring study objectives are met, data is captured accurately and efficiently, and risks and benefits are balanced.

Study Design and Sample Size Calculation

Our team can help design and plan clinical trials by providing sample size calculations, power calculations, and statistical design recommendations.

SAP and Statistical Report

Our team of statisticians provides Statistical Analysis Plans (SAP) and Statistical Reports, including interim analyses, to ensure that clinical trials are conducted with the highest statistical rigor.

Randomization Services

We offer randomization services to support clinical trials, ensuring unbiased treatment allocation and minimizing the risk of bias in study results.

SDTM Mapping

We provide SDTM (Standard Data Tabulation Model) mapping services, ensuring that clinical data is mapped accurately and consistently, enabling seamless integration of clinical data from different sources.

ADaM and TFL Programming

Our team of programmers provides ADaM and TFL programming, ensuring that the data is analyzed, and results are reported accurately and efficiently. We use advanced visualization tools and techniques to create interactive and dynamic TFLs.


We offer regulatory submission support, including Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports, and data submission expertise to support regulatory compliance.

Regulatory Submission Support

We specialize in guiding your IND, NDA, and BLA submissions with the FDA, while also providing assistance for submissions to the EMA, PMDA, and other regulatory agencies worldwide.

Rescue Work

We provide rescue work services to clients who are dissatisfied with their current CRO, ensuring continuity of the clinical trial and rescuing it from failure.

Speciality Project Support

One Stop For All Your Requirements

Our Specialty Project service offering in the Biostatistics and Statistical Programming, Data Analytics space includes a range of services to support clinical trial data analysis and reporting. We specialize in helping our clients efficiently navigate the complex landscape of clinical trial reporting requirements and ensuring compliance with regulatory standards.

  • BIMO dataset and listings support

  • DSUR and safety reporting needs

  • CDISC compliance support

  • Ad Comm support

  • Automation services for data mapping, analysis, and reporting

  • Results posting in CT.gov

  • Publications support

  • Consulting on Statistical Computing Environment set-up and configuration

  • Training and support


Enhance Efficiency in Data Analysis

Our automation services help streamline the data analysis and reporting process, allowing for faster turnaround times and more efficient resource utilization. Our consulting services help ensure that our clients have the necessary computing infrastructure in place to effectively support their data analysis and reporting needs. Whether you need assistance with specific project needs or ongoing support for your clinical trial reporting requirements, our Specialty Project service offering provides flexible and customizable solutions to meet your needs. Contact us to learn more about how we can help support your clinical trial reporting needs.

Got Questions? We've Got Answers

How does Clymb differentiate between an FSP vs. an Outsourcing model?

In the FSP model, you gain customized control over data, timelines, and processes through an insourced approach. This allows your team to shift its focus from day-to-day project work to strategic decision-making. The emphasis is on dedicated project resources, guided by Clymb's Project Manager, making it adaptable for pharmaceutical companies of any size.

While the Outsourcing model with Clymb concentrates on specific data functions, departing from the conventional CRO "Data 2nd" model. It offers competitive pricing achieved through Clymb's automation and low-cost and mid-cost centers, resulting in significant cost savings. Leveraging automation ensures expedited timelines for quicker access to data, making it highly effective for niche projects and specialized tasks that require dedicated attention.

What software and tools are in place at Clymb Clinical to facilitate our outsourcing services?

We harness the capabilities of validated SAS and R statistical software packages, readily accessible to our team via Microsoft Azure cloud environments. In tandem with these robust platforms, we employ our proprietary tools such as SDTM Mapper and TFL Designer, alongside open source solutions, to create a seamlessly integrated approach that enhances efficiency and reliability, ultimately benefiting our clients. For more detailed insights into the tools and solutions our team utilizes, please visit our Solutions page.

What is your experience in statistical analysis of clinical trials, including specific therapeutic areas and clinical development phase?

At Clymb Clinical, we bring extensive experience to the statistical analysis of clinical trials across a wide range of therapeutic areas and clinical development phases. Our team of seasoned Biometrics and Medical Writing experts has successfully contributed to numerous clinical trials, spanning from early-phase research to late-phase trials and post-marketing studies. Our experience encompasses therapeutic areas such as oncology, immunology, cardiology, infectious diseases, rare diseases, neuroscience, and many others.

What is the pricing structure for Clymb Clinical's outsourcing services?

The pricing model for outsourcing services at Clymb Clinical may vary depending on the specific nature of the project and the preferences of our clients. We offer both Time and Materials (T&M) and Fixed Unit-based pricing options to accommodate different needs and project requirements.

For detailed information about the pricing structure for a specific project or service, we encourage potential clients to contact us directly. Our team will collaborate with you to determine the most suitable pricing model for your outsourcing needs.


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Accelerating Clinical Trials With Data-Driven Insights