Delivering exceptional quality is our highest priority

We are your go-to experts for clinical trial reporting, equipped with a team of highly skilled biostatistical programmers who excel in managing every facet of your trial, from initial protocol creation to final regulatory filing. Our deep expertise in regulatory requirements and industry standards ensures that we deliver top-notch quality in every aspect of our work. Whether you're aiming for FDA, EMA, PMDA, or NMPA approval, we craft precise, submission-ready packages tailored to your needs. By working closely with your team and maintaining open, proactive communication, we seamlessly integrate into your project, becoming a vital partner in achieving your goals.

Programming Expertise

CDISC Compliance

DISC compliance is at the core of our operations. We possess extensive expertise in developing CDISC-compliant SDTM and ADaM datasets, along with essential supporting documentation such as SDTM-annotated CRFs, Define.XML, and Reviewer’s Guides.

Automation

Our proprietary tools, leverage AI to automate key processes for TFL and SDTM. Developed by our Operational Excellence team, these solutions ensure repeatability, adaptability, and uniformity, while maintaining the highest standards of reporting quality for your study.

Advanced Coding using SAS and R

Our statistical programming team consists of industry-leading experts in both SAS and R. We can harness the strengths of both languages to deliver FDA-compliant results while also excelling in advanced statistical modeling. With our extensive experience and technical proficiency, we are well-equipped to meet your data analysis needs with precision and insight.

Support From Full Spectrum of Drug Development

Phases I–IV and Integrated Summary of Safety/Efficacy (ISS/ISE)

Participating in
Data Monitoring
Committees (DMC) and DSUR

Developing analysis datasets and tables, listings and figures

Bioresearch
Monitoring (BIMO)
requirements

SAS and R programming

Participating in DSUR