Statistical Consulting

Optimize your clinical development—from study design to submission and beyond—with our innovative statistical strategies

Reduce costs and timeline of your clinical trial

Our dedicated, in-house experts use the most innovative methods to support the development of study designs across a wide range of therapeutic areas and phases for both medical devices and drugs.

We’ll work closely with you to support regulatory interactions and oversight implementation.

No matter how complex your project, get tailored, comprehensive support, including:

Statistical strategy for clinical development plans
Study design and protocol development
Power and Sample size calculation
Implementation of complex statistical methodologies
Support for interim analyses
Support for Data Monitoring Committees / Data Safety Monitoring Boards
Support for regulatory interactions

Our offering includes

Study Design

We can build study designs in collaboration with clinical teams to best suits the scientific and medical environment and ensure regulatory or post-submission requirements are met. In particular, our team has a breadth of experience in adaptive and sequential designs and can run simulations to evaluate and optimize design options.

DMC / Interim Analyses

Our expert consultants can act as independent statisticians in a number of external study committees like DMCs or safety committees. They bring their statistical expertise in supporting DMCs with implementation and review of data analyses to assist with recommendations and decision-making process while ensuring integrity of the trial. We can offer a comprehensive package to support planning and logistics of blinded and unblinded teams that fits your needs.

Regulatory Interactions

Our experience in interacting with regulators, including FDA and EMA, across all types of meetings allows us to provide strategic insights in your interactions. We can support you by attending meetings to represent statistics or in defending statistical methodologies and answering questions related to statistics.

Complex Statistical Methods

We can support your team in implementing and interpreting complex statistical methodologies by writing sections of protocols or analysis plans or help with the programming and review of analyses.

Why choose Alira Health?

Alira Health biometrics team has provided expert statistical guidance for over 500 projects. As our partner, you’ll benefit from:

Working with the subject matter experts and statistical consultants with over 20 years of clinical development experience
Strategic input on clinical development plans and protocols
Strong know-how in the latest statistical methods
Direct access to an in-house team of regulatory experts