Biostatistical consulting for confident clinical decisions

From early protocol design to final regulatory submission, our senior biostatisticians help you choose the right methods, defend them to regulators, and turn complex data into clear answers. Twenty-plus PhD-level statisticians across phases I–IV and every major therapeutic area.

Explore capabilities Talk to an expert

Regulatory expertise

A reliable, long-term partner for statistical and regulatory needs.

Metronomia provides biostatistical consulting to pharma and biotech sponsors across every phase — from study design through regulatory submission. Our senior statisticians sit in the same rooms as your clinical and regulatory leads, and the methodology we recommend is the methodology we will defend to the agency.

Over the past five years we have supported 50+ regulatory interactions with FDA, EMA, MHRA, BfArM, and PEI — including scientific advice, pre-submission meetings, Type B / C briefing books, and inspection-readiness work. For active authority Q&A, our team has a proven record of delivering data and analyses on a 24-hour turnaround.

When the question goes outside our day-to-day expertise, we also have a curated network of independent KOLs we bring in for second opinions — including on novel oncology designs and Project Optimus-aligned dose optimisation.

What we do

End-to-end biostatistical expertise

We embed with your team early — shaping study design, defining endpoints, and writing the SAP — and stay through database lock, analysis, reporting, and post-submission queries.

Dose escalation & finding

Adaptive Bayesian designs

Selection and implementation of BOIN and CRM dose-escalation designs — plus classic 3+3 where it remains the right call.

Dose finding (MCP-Mod)

Single, two-, or multi-stage Phase II designs and head-to-head comparisons. MCP-Mod for dose-response in line with current EMA / FDA expectations.

Project Optimus alignment

Oncology dose-optimisation work that anticipates FDA Project Optimus expectations — selecting registration doses regulators will accept.

Study design & analysis strategy

Protocol input & review

Trial design strategy, endpoint selection, randomisation, and statistical sections — from FIH through pivotal phase III.

Sample size & power

Power calculations and sample-size justification for superiority, non-inferiority, equivalence, and group-sequential designs.

Synthetic & external controls

Synthetic, external, or historical control arms — including propensity-score matching for hybrid designs.

Adaptive & interim analyses

Seamless adaptive Phase 2/3

Seamless phase II/III designs, sample-size re-estimation, and other adaptive features — planning, simulation, and execution.

Blinded / unblinded interims

Planning, simulation, and execution of blinded and unblinded interim analyses for sponsor decision-making.

SAP & estimand framework

SAP development with full mock TFLs, ICH E9(R1) estimand framework, and CDISC alignment from day one.

Submission & integrated reporting

Integrated summaries (ISS/ISE)

Pooled safety and efficacy analyses across studies — full traceability for marketing applications.

Interim analyses & DMC

Independent unblinded biostatistician services, charter writing, charter review, and interim reporting.

Scientific advice & briefings

Authoring statistical sections of FDA Type B/C and EMA scientific-advice briefing books, plus live support through agency Q&A.

How we work

A consulting partnership, not a hand-off

Every engagement starts with a senior statistician sitting alongside your clinical and regulatory leads — and stays there until the data is locked, the report is signed, and the submission is filed.

01
Discover

We start with your scientific question, regulatory pathway, and programme-level constraints — not a template.
02
Design

Protocol-stage statistical strategy, endpoint definition, sample size, and SAP — written to be defended.
03
Analyse

Blinded reviews, interim analyses, DMC outputs, and final analyses — fully traceable and reproducible.
04
Deliver

CSR statistical sections, ISS/ISE, briefing-book input, and live support through regulator queries.

Why sponsors choose us

Senior statisticians, low turnover, no surprises.

50+ regulatory interactions in 5 years

24-hr turnaround for authority requests

30 active stats consulting projects

800+ studies delivered

75% repeat business

I–IV all clinical phases

Frequently asked

Questions sponsors actually ask

Are you big enough for a pivotal phase III?

Yes. We routinely lead pivotal studies and have supported 800+ trials across all phases. Our 95% staff retention means the team you sign on is the team you finish with.

How much regulatory-interaction experience do you have?

Over the past five years we have supported 50+ regulatory interactions with FDA, EMA, MHRA, BfArM, and PEI — including scientific advice, pre-submission meetings, and inspection-readiness work. For active authority Q&A, we routinely deliver data and analyses on a 24-hour turnaround.

How do you align with ICH E9(R1) on estimands?

Every SAP follows the estimand framework end-to-end: target population, treatment, endpoint, intercurrent event handling, and population-level summary. We document each choice with regulatory rationale.

What is your inspection track record?

We have completed multiple sponsor-triggered FDA, EMA, and Swiss Medic inspections covering CDM, biostatistics, CSV, and CSR — with no critical or major findings to date.

Can you embed biostatisticians on an FSP basis?

Yes. We offer fully embedded biostatisticians under FSP, supplemental staffing for peak demand, and full project-based delivery — including transition between models.