Biostatistical Consulting
Seamless and robust statistical support across all phases of the drug development lifecycle
At Allucent, our team of biostatistical consultants are highly experienced statisticians dedicated to seamlessly supporting sponsors throughout their asset development lifecycles as part of the core clinical team.
Biostatistical Consulting – Early Phase through Marketing Application
Having backgrounds appropriate for a specified therapeutic area and/or phase, our experts provide input into development plans.
Our biostatistical consultants provide robust and efficient design recommendations, from first-in-human studies through to pivotal trials (e.g., from PIND/IND through NDA submission), while being mindful of post-marketing goals.
Biostatistics Regulatory Expertise
Our biostatistical consultants have global experience with regulators in various therapeutic divisions/areas and alternative regulatory paths such as orphan drug, breakthrough therapies, accelerated, and fast-track.
Allucent’s expert biostatistical design advice is guided by our A-Team’s prior regulatory experience over multiple therapeutic areas, resulting in successful: regulatory body interactions; health authority meeting representation; statistical explanations/justifications for novel and standard methods and designs; and approval submissions.
Biostatistics Study Design Support
Having backgrounds appropriate for a specified therapeutic area and/or phase, our experts provide input into study protocols, with a focus on statistical design and analysis features, including:
- Objectives and endpoints
- Power and sample size
- Assessment scheduling
- Interim analysis and go/no-go decisions
- Study integrity including bias and blinding
- Endpoint evaluation (i.e., inferential analysis and alpha control method)
- Estimand definitions
Allucent Biostatistical Consulting Services
- Due diligence and gap analysis
- Proof of concept study design and endpoint evaluation, including early endpoint identification
- Estimand rationale and documentation
- Study design, including novel adaptive designs/interim analysis
- Regulatory consultation (i.e., FDA, EMA, and other regulatory agencies/authorities) for statistical/study design issues
- Biostatistical input for clinical development plans
- Regulatory meeting preparation and biostatistical representation (e.g. Pre-IND/IND, SPA, Scientific Advice, EOP2, Pre-NDA/BLA, Advisory Committee)
Sponsor Proxy Statistician
Allucent biostatistical consultants act as subject-matter experts on behalf of our sponsors, providing, biostatistical support and oversight over third party vendors, where appropriate, to ensure the highest level of quality service for your projects/programs. Project-level statistical oversight duties can include vendor documentation input and deliverable review/input, as per the following examples:
Sponsor Proxy Statistician List
- IRT plans
- Randomization schedules (as appropriate)
- Data management documentation (e.g. CRFs, DMPs, edit check plans)
- Charters (SRC, DSMB, DMC, or other)
- Statistical analysis plans/interim analysis plans
- CDISC documentation
- Dry run, interim, and final tables, listings, and figures
- Inferential methods and code
- Clinical study reports
- Quality risk management plans, quality tolerance limits.
Additional services may include ongoing biostatistical vendor management with respect to deliverable timelines and directional guidance to vendors for analysis and data handling questions as they arise, with all activities performed while being mindful of, and contributing to, the advancement of sponsor program development plans.
Ad hoc Analyses
Allucent biostatistical consultants conduct ad hoc analyses and provide representation and writing support for sponsor presentations including internal management/planning meetings, investor meetings, manuscripts, abstracts, and other scientific presentations. Our biostatistical consultants think outside the box and will discuss the goals for each presentation, developing analysis plans together with sponsors to generate meaningful scientific content.
“Radiopharmaceuticals are emerging as an important cancer treatment option. It is vital to address study design features inherent to radiopharmaceutical trials to ensure that analysis results reflect estimates of endpoint improvements that are interpretable by regulators during milestone and submission reviews.”
Vanessa Beddo
VP, Global Head of Biostatistical Consulting
