Biometrics
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:
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
Explore our Biometrics Offerings:
Our comprehensive clinical trial services and solutions provide flexible, scalable guidance designed to optimize outcomes: