Biostatistics expertise across every clinical trial phase

Whether you are planning a first-in-human study or preparing a regulatory submission, our senior biostatisticians become an extension of your team; shaping study design, defining the statistical strategy behind it, and producing analyses that hold up under regulatory review.

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Service & methodology coverage

How our expertise underpins each area of biostatistics

Study design & statistical analysis planning

Statistical strategy defined from the start, with the right study design, endpoints and analysis approach in place before the first patient is enrolled.

Study design & protocol development Design consulting, sample-size calculations and statistical input to the protocol.
SAP development Statistical analysis plans, estimand strategy and ISS/ISE planning, written to survive review.
Randomisation Randomisation schedule development and independent randomisation services.

Programming, standards & reporting

SAS programming, CDISC standards and submission-ready reporting across the full biometric data chain.

Statistical programming SAS programming with independent validation, data integration and ad-hoc reporting.
Reporting & publications Statistical and clinical study reports, submission packages and manuscripts.

Trial oversight & monitoring

Independent study oversight, including data monitoring committees, vendor coordination and support when studies face delivery challenges.

DMC / DSMB & interim analysis Independent statistician and voting (i)DMC member, charters and interim analyses.
Vendor oversight support Subject-matter experts ensuring ICH-GCP E6(R2) oversight of outsourced work.
Rescue services Scalable support from limited scope to full operational take-over.

Specialist statistics & consulting

Senior statistical expertise for complex questions, from advanced modelling and non-clinical statistics to strategic consulting.

Statistical expert services Statistical modelling & simulation, PK/PD analysis and strategic representation.
Non-clinical statistics Design of Experiments, CMC statistics and 3R-principle in vivo models.
Biostatistical consulting A broad range of statistical consulting beyond core delivery.

Where our biometrics expertise shows up in delivery

Clearer trial decisions

Interim insight

Interim analyses, DMC outputs and blinded reviews follow clear, pre-specified rules, helping teams respond to emerging data with confidence while the trial is still ongoing.

Connected data flow

One data standard

Biostatistics, programming and data management work to the same CDISC-aligned standards, so data moves smoothly from EDC through analysis and into submission without unnecessary rework.

Submission-ready outputs

Built to defend

We produce TFLs, CSR statistical content and ISS/ISE deliverables that are traceable, reproducible and aligned with the pre-specified analysis, making the final evidence easier to review and defend.

Senior expertise built in

Continuity

The senior biostatisticians involved at protocol stage stay close to the study through database lock and regulatory follow-up, preserving context and avoiding the disruption of repeatedly re-learning the trial.

Consulting

Biostatistics consulting

Some questions are best answered before the protocol is written. Our senior biostatisticians advise on study design, statistical approach and regulatory readiness, with consulting support for the questions that need a closer look.

Explore consulting services

Endpoint & estimand strategy (ICH E9(R1))
Study design, sample size & adaptive methods
Independent statistical review
Submission-readiness & due diligence

Experience built into every study

20+ PhD biostatisticians

36 years of experience

800+ studies delivered

180+ phase II studies

120+ phase III studies

I–IV all clinical phases

Statistical computing

SAS
Submission
Primary submission environment per FDA expectation. SAS for SDTM, ADaM, TFL, and validation programmes.
R
Analysis
Graphics, exploratory analyses, and ADaM derivations where the sponsor framework supports it. Validated R packages for clinical use.
rpact
Adaptive
R package for adaptive clinical trials — group-sequential, sample-size re-estimation, and seamless Phase 2/3 designs.
PASS
Power
Power Analysis & Sample Size — sample-size justification for protocol and SAP sections.

Validation, monitoring & PK

Pinnacle 21
CDISC
CDISC validation built into every SDTM and ADaM release. Conformance reports shipped with the deliverable.
seeWISE
Review
Medical data review and visualisation — embedded into the data pipeline for cross-study safety review.
CluePoints
RBQM
Risk-based quality management with KQI/KRI dashboards and statistical monitoring across the portfolio.
Phoenix WinNonlin
PK
PK/PD analysis — compartmental, non-compartmental, and population PK modelling for FIH and beyond.

Questions we’re often asked

Do you take on adaptive designs end-to-end?

Yes — sample-size re-estimation, seamless phase II/III, BOIN/CRM/mTPI dose-finding, basket and umbrella trials. We write the adaptive sections of the protocol and the IDMC charter, and we execute the interim work.

How do you handle ICH E9(R1) estimands?

Estimand framework end-to-end: target population, treatment, endpoint, intercurrent-event strategy, and population-level summary. Standard intercurrent events are pre-specified in the SAP with regulatory rationale for each strategy choice.

Can you work on an FSP basis?

Yes — single-discipline biostatistics FSP, multi-discipline FSP (biostats + programming + CDM), and hybrid models that combine FSP with project-based surge for submissions or rescues.

Have you supported pivotal regulatory submissions?

Many times. Multiple sponsor-led FDA and EMA submissions; multiple sponsor-triggered inspections covering biostatistics, all closed with no critical or major findings. ISS/ISE work is a regular part of our portfolio.

Biostatistics expertise across every clinical trial phase

How our expertise underpins each area of biostatistics

Study design & statistical analysis planning

Programming, standards & reporting

Trial oversight & monitoring

Specialist statistics & consulting

Where our biometrics expertise shows up in delivery

Clearer trial decisions

Connected data flow

Submission-ready outputs

Senior expertise built in

Biostatistics consulting

Experience built into every study

Statistical technology matched to the study

Statistical computing

SAS

R

rpact

PASS

Validation, monitoring & PK

Pinnacle 21

seeWISE

CluePoints

Phoenix WinNonlin

Questions we’re often asked

Related services

Clinical Data Management

Statistical Programming

Medical Writing