Biostatistics and Programming

We Understand Your Biostatistics Challenges:

  • Does your CRO use offshore SDTM teams to create SDTM data?
  • Does your Stats team typically get involved in the database build and study start-up tasks?
  • Does your CRO underestimate the amount of work required then ask for change orders to drive profits?
  • Have your CRO Biostatisticians represented Statistics in regulatory submissions throughout the approval process and lifecycle management?
  • Is your Biostatistics team committed and engaged in your clinical studies?

Turning Data into Conclusions

ARG Biostatistics is made up of a team of industry professionals working to deliver top products and services to our clients, providing excellent consulting and guidance throughout the lifetime of our partnerships. Internally-based from beginning to end, our statistical programmers and biostatisticians and their backups are assigned for the duration of projects. This commitment results in a team of statisticians that understand and can explain your data. 

We view each study as an analytic journey, improving, optimizing and deriving solutions in order to turn your data into actionable insights. These efficiencies allow us to focus on the most important things in each study, and have built the experience we use to predict and budget the correct amount of work it will take to complete a project. The human factors of low turnover, engagement, curiosity, and integrity lead to proactive partnerships between our sponsors and ARG Biostatistics.

“It is refreshing to be somewhere where the statisticians work with the sponsor on what makes sense for their study.”
“It is great to get to remain on a project through a complete life cycle. Working on just one time point of a study can sometimes create tunnel vision. At ARG, it is really cool to see how each component plays a role in the end product.”
Cindy Dulaney, Analytical Programmer

Main Biostatistics Offerings

CDISC Experts
ARG is a Gold Member of CDISC and has staff that are extensively experienced in CDISC compliance.

Independent Double Programming
ARG Biostatistics provides the industry standard with electronic comparison process for all programmed deliverables.

Delivery Promise
We offer five days from database lock for topline, three weeks for full report.

TLF Production
ARG uses senior-level statisticians to ensure appropriate statistical analyses are implemented for study reporting.

Analysis Plans
ARG uses experienced, internal staff members to prepare plans for diverse clients in multiple therapeutic areas.

Randomization Schedules
We design plans that fit the systems and processes you are using.

The ARG Difference

Regulatory Experience

ARG Biostatisticians have experience in over 15 NDAs/MMAs, providing lead work on four and have engaged with regulators in North America and Europe in all phases of development.

End-To-End Lead Statistician and Lead Programmer Assignments

ARG assigns team members for the duration of the study. This means the work done on all components of the study are performed by the same individuals, and there are no single task teams.

Realistic Estimates for CDISC and TLF Generation

ARG will provide a table of contents for SDTM, ADaM and TLFs based on materials presented, not use arbitrary numbers to win the award. ARG statisticians will always take a critical view of the project and recommend the best solution for you, not necessarily what is best for ARG.

Assign Associate Lead

ARG emphasizes continuity, assigning an understudy Statistician and Programmer to each project (that are engaged throughout the study to provide reliable backup during absences). 

Statisticians Perform a Significant Amount of Programming

ARG understands that the knowledge statisticians gain by programming datasets and TLFs provides a better product.

Strategic Statisticians

ARG statisticians have solid experience across the pharmaceutical industry and can provide strategic solutions for program development, protocol development, endpoint exploration and evaluation.

CASE STUDY

ARG Provides

Strategy and Regulatory Assistance

The CHALLENGE

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.

The SOLUTION

ARG suggested applying a novel Bayesian approach to the study. The Bayesian Optimal Interval Design was recommended. 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.

MOVING FORWard

ARG Biostatistics and Data Informatics proved they are strategic partners on client projects. In this example, the statisticians used their experience to participate in the study design, then played roles in the ensuing regulatory interactions. ARG Biostatistics makes multiple impacts on each study, all of which directly provide value to the client.