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Biostatistics & Programming

Are You Looking for Biostatistics from a CRO that Will...

Engage fully in your project, database build, and start-up tasks?
Prioritize transparency with budget and amount of work needed?
Use statistics in approval submissions and lifecycle management?

ARG’s Biostatistics team of experienced professionals will work to turn your data into conclusions.

Tell Us About Your Study

What do ARG’s Biostatistics Services Include?

Experienced CDISC Experts

Gold Member of CDISC with staff who are extensively experienced in CDISC compliance.

Delivery Promise

Topline report delivered five days from database lock and full report within three weeks.

Analysis Plan Preparation

Experienced, internal staff members to prepare plans for diverse clients in multiple therapeutic areas.

Independent Double Programming

Industry standard of electronic comparison process for all programmed deliverables.

TLF Production

Senior-level statisticians to ensure appropriate analyses are implemented for study reporting.

Randomization Schedules

Plans designed to fit the systems and processes every unique sponsor uses.

Meet an ARG Senior Biostatistician

Mark Evangelista - Biostatistics for Clinical Trials

Mark Evangelista

Senior Biostatistician

ARG biostatisticians are much closer to the data than at other CROs. Our statisticians work alongside programmers on technical programming tasks, creating a collaborative environment that ensures high quality deliverables to the sponsor.

Why Choose ARG for Your Biostatistics Needs?

Deep Regulatory Experience Experience in 15+ NDAs/MMAs and with global regulators in all phases of development.
Realistic Estimates Real-numbers-based table of contents for SDTM, ADaM, and TLFs to present the best solution.
Statistician Involvement Heavy involvement by statisticians who program datasets and TLFs for a better product.
Consistent Teams Low turnover core teams of statisticians and programmers vested in the success of every trial.
Associate Lead and Backups Assigned on-call understudy statistician and programmer for continuity and coverage.
Strategic Statisticians Experience in pharma industry and program development, endpoint exploration, and more.

Case Study: ARG Provides Strategy and Regulatory Assistance

A recent client running a dose-ranging study in oncology observed that their lowest dose was not effective.

The challenge was to find a way to amend the study design from a traditional 3+3 to a design that could potentially enroll fewer than three patients on non-effective doses.

ARG suggested applying the Bayesian Optimal Interval Design approach to the study.

The Biostatistics group worked with the client to define the hypothesized dose toxicity rates, then to produce the operating characteristics for the design.

The ARG team drafted wording for the amendment and helped on the documents submitted to regulatory agencies.

The design and amendment received favorable comments from regulatory agencies and the design is now fully implemented.

Want to chat with ARG about your specific biostatistics needs?

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