ARG’s Biostatistics team of experienced professionals will work to turn your data into conclusions.Tell Us About Your Study
Gold Member of CDISC with staff who are extensively experienced in CDISC compliance.
Topline report delivered five days from database lock and full report within three weeks.
Experienced, internal staff members to prepare plans for diverse clients in multiple therapeutic areas.
Industry standard of electronic comparison process for all programmed deliverables.
Senior-level statisticians to ensure appropriate analyses are implemented for study reporting.
Plans designed to fit the systems and processes every unique sponsor uses.
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.
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.