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Statistical Programming

Maximizing study potential with deep programming expertise and proven processes
92% of our statistical programming team holds a Master’s degree or higher, bringing advanced technical knowledge and industry-specific insight to every project.
We seamlessly adapt to your internal data structures while ensuring full compliance with all global regulatory standards, including CDISC, FDA, and EMA requirements.
From Phase I trials through post-marketing studies, we deliver full-spectrum programming support across all major therapeutic areas.

As a leading Biometrics CRO, Intego Clinical delivers unmatched statistical programming solutions that help clients achieve their clinical goals faster. Through a unique academic partnership and world-class professional development program, our statistical programmers are equipped to manage complex projects with creativity and efficiency. We provide comprehensive, end-to-end services from Phase I through post-marketing across all major therapeutic areas, while ensuring full compliance with global regulatory standards.

With nearly 20 years of experience, Intego Clinical is a trusted Biometrics CRO and a leading provider of statistical programming talent across Ukraine, Poland, Costa Rica, and Central Florida. Through our partnerships with local universities, we’ve built one of the most highly educated and experienced statistical programming teams in the world. Today, 85% of our team members bring more than five years of experience, and our remarkably low turnover rate of just 4% allows us to deliver consistent, long-term solutions from our strategically located global delivery centers.

As a specialized Biometrics CRO, we invest in rigorous in-house training during onboarding to ensure each new team member is fully aligned with client expectations and project requirements—making project kickoffs smooth, seamless, and immediately productive.

What We Offer

Intego Clinical delivers comprehensive, end-to-end statistical programming support from Phase I through post-marketing. As a trusted Biometrics CRO, our team brings deep expertise across a wide range of therapeutic areas, including ophthalmology, oncology, neurology, virology, and more. We provide flexible, high-quality solutions tailored to your data needs, helping you accelerate timelines and meet your clinical goals with confidence.

Services include the following:

  • Creation and validation of statistical tables, listings, and figures (TLFs)
  • Mapping from different data formats to SDTM
  • Validation of previously mapped CDISC datasets
  • Creation of ADaM and SDTM datasets
  • CRF annotations
  • Define.xml development
  • Interim Analysis Support
  • Legacy study data conversion
  • Integrated Summaries of Safety (ISS) and Efficacy (ISE)
  • Data Monitoring Committee (DMC) submission
  • Randomization schedule
  • Validation for eSub compliant programs

Building the Future of Biostatistics Talent

Founded in 2013, the Center for Biostatistical Programming is a unique partnership between Intego Group and Karazin National University, one of Ukraine’s top institutions for science and mathematics. This initiative was created to develop a strong pipeline of clinical programming talent to support the growing needs of the life science industry.

Through this collaboration, Master’s students are trained by leading faculty and experts from Intego Clinical, with a curriculum focused on hands-on experience with best-in-class software and real-world applications. For more than 10 years, this initiative has helped prepare graduates for successful careers in biostatistical programming and provided the foundation for expanding our university relationships and training programs to our offices in the US, Costa Rica, and Poland.

Seamless Integration
Consistent Results

We understand the complexity of global clinical trials, and we know how to deliver. As your trusted Biometrics CRO, we embed deeply within your team and processes to provide programming support that’s efficient, collaborative, and aligned with your success metrics.

Here’s how we ensure every project runs smoothly:

  • Provide programming support across multiple global Phase I‑IV studies with scalable, experienced resources
  • Align with your governance structure for seamless integration into internal teams
  • Consistently meet defined timelines and quality benchmarks
  • Implement and adhere to your standards and SOPs with precision
  • Maintain regular, transparent communication to keep projects moving forward

Built to surpass your goals

GLOBAL REACH

Our programmers are strategically located across Eastern and Central Europe, Central America, and the U.S., enabling around-the-clock support and seamless collaboration with global teams.

COST EFFECTIVE

With delivery centers in cost-competitive regions, we provide high-quality, responsive outsourcing solutions that deliver real value to clients in the U.S., LATAM, and Europe.

HIGH QUALITY SUPPORT

More than 65% of our programmers hold a Master’s degree in Mathematics or Statistics, and 85% have more than five years of experience, bringing expert-level support on every project.

FLEXIBLE ENGAGEMENT

From Functional Service Provider (FSP) partnerships to unit-based project work, we offer engagement models that adapt to your unique needs and goals.

Ready to see what we can do for you?
Let’s talk!

Intego Insights