Biostatistics

Expert statistical insight to guide your study from start to submission

Flexible engagement models allow us to scale seamlessly with your project needs, whether for a single study or a global program.

Our biostatistics team is among the most experienced in the industry, with more than 85% having 5+ years of hands-on expertise.

Backed by nearly 20 years of leadership in the field, we bring deep knowledge of global regulatory and industry standards to every project.

With the right tenured expertise in clinical research and data analysis, Intego Clinical is proud to offer expert statistical consulting to our valued pharma, biotech, and life science industry partners. As a trusted Biometrics CRO, we support studies of all sizes and phases, helping clients strengthen their clinical data and maintaining full regulatory compliance simultaneously. Our team stays current with evolving global standards, including 21 CFR, ICH GCP, US-FDA, UK/NICE SI, EU CTR, and many more. Thanks to high employee retention and a strong global work ethic, Intego Clinical clients benefit from better data insights, consistent collaboration, and proven statistical strategies.

Proven expertise across all major therapeutic areas

Intego Clinical supports sponsors at every stage of the clinical development process with biostatistical expertise tailored to your study’s complexity and scale. From protocol development to submission-ready outputs, our team ensures regulatory alignment and scientifically sound analysis across therapeutic areas.

We provide strategic guidance and hands-on support for:

Protocol Design

Interim Analysis

CDISC Services

Sample Size Calculations

Topline Analysis

ISS/ISE Submission

Randomization Schedule

DMC Support

Statistical Reports

SAP Development

PK/PD Analysis

CSR Review

With nearly 20 years of experience, Intego Clinical has earned a reputation for reliability, consistency, and results. Our strong staff retention and investment in continuous professional development ensure that clients benefit from a knowledgeable, stable team. No matter the regulatory framework, we bring the insight and adaptability needed to support efficient, high-quality clinical studies from start to finish.

Unlock greater value from your clinical data

Recent advances in data science technology enable pharma companies and CROs to get more out of their clinical trial data now than ever before. Intego Clinical is a leader in this field and has developed proprietary platforms to find hidden data patterns and insights within your study data. Our team is fluent in Python, R, R Shiny, and SAS, and our clinical data mining technology incorporates state-of-the-art machine learning algorithms, statistical tools, and data visualization libraries to deliver smart, faster, and more informed decision-making across drug development.

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Global biostatistics services

Our biostatistics team integrates seamlessly into your existing operations, functioning as a true extension of your global network. With delivery centers across the US, Ukraine, Poland, and Costa Rica, Intego Clinical supports globally distributed teams with consistent communication, technical precision, and proven scalability. Grounded in industry best practices and focused on operational excellence, we deliver high-quality, submission-ready outputs that are on time and within budget to allow you to move forward with confidence.

Our services include: