How does Ephicacy ensure quality and accuracy in its statistical programming deliverables?

Quality is built into every stage of Ephicacy’s statistical programming process through a combination of validated systems, rigorous documentation, and independent validation practices. All project implementation is backed by 21 CFR Part 11-compliant systems and well-documented SOPs. For key deliverables like SDTM and ADaM datasets and TLFs, Ephicacy conducts independent programming and validation to catch discrepancies before they reach submission. Automation and process optimization further reduce manual error and improve consistency across projects. The result is a quality framework designed to hold up under the scrutiny of the FDA and other global regulatory agencies.

What are the advantages of using R instead of or alongside SAS for clinical trial statistical programming?

R offers several advantages that are driving its growing adoption in clinical trial programming: Cost efficiency: R is open-source, which can reduce long-term licensing costs compared to SAS Flexibility and innovation: R’s ecosystem of packages supports advanced analytics, custom visualizations, and interactive Shiny dashboards that go beyond traditional TLF outputs Modern workflows: R enables end-to-end statistical programming pipelines that integrate well with contemporary data environments and automation practices Complementary to SAS: Many sponsors adopt R gradually alongside SAS, preserving existing validated workflows while modernizing where it adds the most value

Does Ephicacy provide end-to-end support from data management through to analysis and submission-ready outputs?

Yes. Ephicacy supports every step of the clinical data continuum, from data management through to submission-ready programming deliverables. This includes: Trial design: aCRF development and trial design domain development Standardization: CDISC-compliant SDTM and ADaM dataset specification, programming, and validation; 100% of our programmers have CDISC experience Analysis outputs: Production and independent validation of TLFs Submission support: define.xml, reviewer guides, and Pinnacle 21 validation Specialized analyses: ISS/ISE, interim analyses, PKPD, ePRO, DMC support, and more

Statistical Programming

What Statistical Programming Services Does Ephicacy Provide?

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

Ephicacy offers flexible statistical programming delivery, including:

Scalable coverage via an FSP model
Milestone-based support with project-based services
Using resources where they provide the greatest value, saving you time and money
Extensive R programming expertise to 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
Conference publications

Frequently Asked Questions

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

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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