Statistical Programming

Statistical Programming

With a global team of statistical programming experts and capabilities that cover your entire data life cycle, Ephicacy is ready to provide steady support in a constantly evolving environment. We combine deep real-world and clinical trial data analysis expertise with flexible delivery and a collaborative partnership model. 21 CFR-Part 11 compliant systems and well documented SOPs are the backbone for project implementation, and our focus on automation and process optimization makes us a trusted programming partner.

Comprehensive Programming Services

Our statistical programming services include:

  • Annotated Case Report Form (aCRF) development and trial design domains development
  • Creation of mock shells based on statistical analysis plans
  • CDISC-compliant dataset programming (SDTM, ADaM)
  • Dataset specification development, programming, validation, and quality checks for SDTM and ADaM
  • Production and independent validation of Tables, Listings, and Figures (TLFs)
  • Submission-ready SAS and R programming for clinical trials, tailored to global regulatory agency requirements
  • Integrated Summary of Safety/Efficacy (ISS/ISE) Programming
  • Statistical programming for PKPD, ePRO
  • eSUB Package Preparation (Define.xml, reviewer guides, Pinnacle 21 validation)
  • Patient Profiles and Safety Narratives

End-to-End Data Support

We support every step of your process, with services spanning from data management to data analysis. Because we understand the full continuum of your data needs, we can provide statistical programming support that truly adds value, adapts to your stage, and brings you closer to successful regulatory submission. 

Scalable & Cost-Effective Delivery Models

Whether you need FTEs through an FSP model or to fill internal gaps with project-based services, Ephicacy offers a range of delivery options that scale with your trials. We use resources where they provide the greatest value, saving you time and money while ensuring excellence in statistical programming. Additionally, through extensive R programming expertise, we can help our clients unlock long-term value.

Global Regulatory Expertise

Ephicacy has a global presence, as well as far-reaching experience with regulatory bodies worldwide. We’ve successfully supported FDA and other global approvals across therapeutic areas. This gives us the insight to ensure your data analytics are in line with your end goal and in compliance every step of the way.

Analytics to Accelerate Clinical Milestones

We provide statistical programming for CSRs, interim analyses, integrated analysis (ISS/ISE), DMCs, PSUR, DSURs, BDR/DTR, Bioresearch Monitoring (BIMO), advisory committees, rapid responses, manuscripts, IBs, and conference publications.

Leverage Our Data Expertise

Reach out to learn how Ephicacy’s statistical programming team can provide the quality, transparency, and efficiency your trials deserve.

Connect With Us

Hear From Our Clients

“I just wanted to recognize the significant contributions from Ephicacy team, which helped us to deliver multiple deliverables on time (which did have rather tight timelines). The deliverables were created using latest TLG automation system and in each case we had need for programmatic validation of the input ADaM data and the system produced outputs. The team was able to complete their assigned validation work well within the required timelines, allowing for us to get the two sets of deliverables out on time. Another deliverable, which included the validation of efficacy supporting endpoints and the validation of an efficacy table and plot, was particularly challenging and I was impressed by their ability to handle independently.”

Manager, Statistical Programming, Large Pharma

“I wanted to send a thank you for your partnership. We are grateful for your support and dedication, and we sincerely recognize your staff’s hard work and commitment to the success of our Statistical Programming organization. We also appreciate everything you have done to continue building a strong partnership.”

Executive Director, Statistical Programming, Large Pharma

“Thank you for your exceptional work on statistical programming deliverables. Your attention to details and timely contributions were crucial to our successful deliverables. Your efforts have been invaluable to our team’s success. I feel fortunate to have your amazing support and help!”

Therapeutic Area Asset Lead, Large Biopharma

Experience the EPHICACY EFFECT

See firsthand how our clinical biometrics solutions can 
deliver speed, efficiency, and reliability for all your data 
needs. Submit your information.

A focused woman wearing glasses looks at data and mathematical equations projected in front of her, symbolizing technology, analytics, and innovation, with warm orange and cool blue lighting effects surrounding her.