Biostatistical Consulting

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.

Regulatory Strategy

Allucent biostatistical consultants assist sponsors during early stages of clinical development (or acquisition), performing due diligence reviews and contributing biostatistical 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.

Allucent biostatistical consultant design advice is guided by prior regulatory experience over multiple therapeutic areas, resulting in successful: regulatory body interactions; meeting representation; statistical explanations/justifications for novel and standard methods and designs; and approval submissions.  Our biostatistical consultants have global experience with regulators in various therapeutic divisions/areas and alternative regulatory paths such as orphan drug, breakthrough therapy, accelerated, and fast-track.

At the study level, our biostatistical consultants, having backgrounds appropriate for a specified therapeutic area and/or phase, 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 consultant services include the following:

• 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:

• 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.

Further, services may additionally 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.