Biostatistics – inference Inc.

Statistical Excellence: Driving Innovation in Drug Development.

At the core we are a statistical company. Our expertise is in Statistics as it is applied to all phases of drug development.

We do it deliberately, efficiently, and with passion. We focus on current regulatory frameworks, innovative designs & analytical methods.

Our expertise is in providing statistical consulting, program development, comprehensive data analysis, and clear reporting that meets our sponsor’s goals.

• Innovative Clinical Trial Design Services – Our biostatisticians work collaboratively to implement Adaptive and Bayesian methodologies to hasten a development plan carefully. Our team can discuss, answer questions, and defend the trial design to regulatory agencies. The collective goal is to design a study to address multiple objectives and capture as much information to make decisions that can be value-driven.

Adaptive designs can:

Reduce the number of subjects
External data to accelerate recruitment and inform on the treatment effectiveness
Lower costs without compromising study outcomes
High communication by working closely with our clients

• Causal Inference Expertise – Leverage advanced methods such as propensity score analysis, expert-driven Directed Acyclic Graphs (DAGs), G-estimation, IP-weighting, marginal structural models, and instrumental variables to analyze observational studies. 

• Evidence-Based Decision-Making – Integrate observational study results and insights to enhance your evidence base. 

• Prognostic Score Implementation – Strategically reduce sample sizes and speed up enrollment while minimizing costs. 

• Comprehensive Data Analysis – Experts in bioinformatics, translational research, and pharmacokinetic (PK), and Epidemiology/Evidence Synthesis to provide clear, actionable insights.

Services Include

Data Monitoring Committee (DMC)

We prepare DMCs by helping draft the Charter, recruiting the voting member statistician in the committee, and/or supporting the committee with statistical outputs. We have also participated as a voting member of the safety committees.

Regulatory Interaction

We are happy to defend the design and the statistical methodology we suggest in the protocol and the SAP to the regulatory bodies. We have had experience in preparing briefing books, providing written responses to the agencies, and also numerous interactions with the agencies in face-to-face meetings.

Our clients find us a strategic partner to reliably deliver on various tasks by our statistics group:

Consulting on development plans
Statistical input in protocols, and preparation of statistical section including sample-size detarmination
Provide expertise on statistical designs including adaptive designs
Preparation of Statistical Analysis Plans
Support safety and dose selection committees
PK data modeling