Statistical precision.
Every submission.
MMS biostatisticians embed directly into your clinical development team — delivering regulatory-ready analyses, adaptive trial designs, and simulation-powered insights that accelerate your path to approval.
500+
SAPs delivered
20+
Years experience
100%
Regulatory ready
Statistical errors don't just delay trials. They can end them.
Clinical biostatistics sits at the intersection of scientific credibility and regulatory acceptance. One miscalculation — in your SAP, your sample size, your endpoint — can trigger agency questions that cost months, or worse, compromise your entire programme.
Pharma sponsors increasingly face complex, adaptive trial designs and multi-regional submissions that demand biostatistical expertise beyond what in-house teams can provide at every stage. The gap between your data and your approval hinges on who interprets it.
Inadequate sample size calculations
Underpowered trials fail at the analysis stage. Overpowered trials waste budget and time. Getting this right from the start is foundational to trial success.
SAP deficiencies that invite agency scrutiny
Incomplete or inconsistent Statistical Analysis Plans raise red flags with FDA, EMA, and PMDA reviewers — slowing your path to approval.
Limited simulation capability for adaptive designs
Modern trials require simulation-based decision support. Without it, sponsors are flying blind through complex adaptive protocols.
Disconnected biostatistics and clinical teams
When biostatisticians operate in silos from clinical, medical writing, and data management, the risk of inconsistency compounds across deliverables.
Data-driven biostatistics.
Built for approval.
Our biostatisticians are industry-educated, clinically fluent, and experienced across every phase of drug development — embedded in your team, speaking your language from Day 1.
Regulatory-first methodology
Every analysis, every plan, every output is designed to withstand the scrutiny of FDA, EMA, and global health authority review. We know what reviewers look for — because we've seen what fails.
Embedded team model
We don't just deliver documents. Our biostatisticians integrate with your clinical, medical writing, and data management teams — ensuring consistency and coherence across every deliverable.
Simulation-powered design
Powered by KeryxCloud from Exploristics, we bring advanced simulation capabilities to study design — enabling you to evaluate scenarios, quantify risk, and make confident decisions before trial starts.
End-to-end lifecycle support
From protocol development through to ISS/ISE and NDA/BLA submission, MMS biostatisticians are present at every critical milestone — not just the deliverable moments.
True partnership accountability
When you engage MMS, you're not getting a vendor. You're getting a partner who takes ownership of outcomes — responsive, adaptable, and invested in your success the way you are.
Global regulatory coverage
With deep experience across US, EU, Japan, and emerging markets, our biostatistics team ensures your analyses meet multi-regional standards for complex global submissions.
Biostatistics support across the full development lifecycle
Every engagement is tailored to your compound, your timeline, and your team's capabilities — from first-in-human through post-marketing.
Sample Size & Power Calculations
Rigorous sample size determination for Phase I-IV trials across all endpoints — primary, key secondary, and exploratory — with full scenario sensitivity analyses and regulatory justification documentation.
Statistical Analysis Plans (SAP)
FDA/EMA-compliant SAPs developed in close collaboration with your clinical and medical writing teams. We build SAPs that are complete, pre-specified, and defensible at submission — minimising agency questions.
Statistical Analysis & Programming
Full TFL (Tables, Figures, Listings) production in SAS and R, including CDISC SDTM/ADaM derivations. Our programmers work in lockstep with our statisticians to ensure analytical consistency from plan to output.
Randomisation & IWRS Strategy
Study randomisation schedule generation, stratification strategy development, and IWRS/IXRS collaboration. Covering simple, block, minimisation, and adaptive randomisation schemes.
DSMB & Interim Analysis Support
Independent DSMB statistical support including unblinded interim analyses, safety data reviews, stopping rule implementation (O'Brien-Fleming, Lan-DeMets), and closed-session reporting packages.
Regulatory Submission & ISS/ISE
Integrated Summary of Safety and Efficacy development for NDA, BLA, MAA, and 510(k) submissions. Including benefit-risk frameworks, meta-analysis, and pooled analysis across your entire clinical programme.
Advanced simulation through our platform
In 2025, MMS expanded its biostatistics and data science expertise through the acquisition of Exploristics — bringing KerusCloud, a leading cloud-based simulation platform, to every client engagement.
KerusCloud enables MMS biostatisticians to run thousands of trial simulations before a single patient is enrolled — quantifying risk, accelerating design decisions, and building the evidence base for regulatory interactions.
Simulate alternative study designs including novel and complex adaptive protocols to predict outcomes and mitigate risk
Integrate real-world data into simulations for more robust, evidence-based study planning
Streamline the trial design process, saving sponsor time and resource costs
Accelerate timelines and cut pre-trial costs before a study begins
Deliver regulatory-ready simulation outputs to support IND, Scientific Advice, and pre-Phase III meetings
Study Design Simulator
Phase III Adaptive design - interim at 50% enrollment
94%
POWER ACHIEVED
-18
SAMPLE SIZE REDUCTION
10k+
SIMULATIONS RUN
3.2mo
TIMELINE SAVED
A methodology built for your programme — not a template
From initial scoping to final regulatory submission, our integrated biostatistics process ensures nothing is left to chance.
Programme Discovery
We immerse in your compound, indication, and regulatory landscape before a single recommendation is made.
Design & Simulation
KerusCloud-powered simulation of study designs, sample sizes, and adaptive decision rules across multiple scenarios.
SAP & Estimands
Development of ICH-E9(R1)-aligned SAPs with full estimand framework, sensitivity analyses, and regulatory positioning.
Analysis & TFLs
End-to-end statistical analysis delivery in SAS/R with CDISC-compliant ADaM datasets and complete TFL packages.
Submission Ready
ISS/ISE and regulatory dossier integration, agency response support, and on-call biostatistical advisory through approval.
500+
Statistical Analysis Plans delivered across Phase I-IV
90%
Of trials completed to timeline with MMS biostatistics
20+
Therapeutic areas supported globally
2006
Founded. Nearly two decades of regulatory trust
What differentiates MMS from
other CROs?
We built a different model — one that serves sponsors who can't afford
biostatistical failure.
Responsive
MMS takes responsibility for the success of every project — with consistent staff and proactive solutions that exceed what a standard CRO partner delivers.
Adaptable
Your satisfaction and outcomes depend on our ability to remain nimble — making smart decisions based on scientifically sound data and real-world sponsor needs.
Focused
As a data-specialist CRO, biostatistics is not a supporting function — it is our core. We have the processes, talent, and technology that accelerate approval and de-risk development.
During a Pharma Acquisition: A Proactive Approach by MMS
When a sponsor faced a complex acquisition mid-trial, MMS biostatisticians provided primary endpoint analysis, interim DSMB support, and data review profiles — ensuring programme continuity through a period of significant organisational uncertainty.
Our team delivered a complete statistical package within compressed timelines, navigating a database lock, interim analysis, and regulatory query response — simultaneously.
100%
On-time delivery of SAP and TFLs
0
FDA queries on statistical methodology
3
DSMB sessions supported without delays
-6wk
Timeline recovery vs. original projection
Parallel workstream delivery across 8-week sprint
All deliverables aligned with EMA/FDA ISS/ISE guidance. Zero statistical queries received.
The MMS biostatistics team are all superstars. You have delivered to timelines throughout, and we really appreciate it. Thank you.
Common questions about biostatistics CRO services
Can't find what you need? Talk directly to one of our lead biostatisticians — no sales process, just answers.
Ask a BiostatisticianA biostatistics CRO (Contract Research Organisation) provides specialist statistical support for clinical trials and drug development programmes. Services include sample size calculations, statistical analysis plan (SAP) development, statistical programming (TFLs), interim analysis support, DSMB statistical services, and regulatory submission support including ISS/ISE development. MMS provides all of these services with a team of industry-educated biostatisticians experienced across Phase I through Phase IV trials globally.
Unlike full-service CROs where biostatistics is one of many departments, MMS is a data-specialist CRO where biostatistics is a core capability. This means deeper expertise, more senior biostatistician allocation, greater responsiveness, and a more embedded model with your internal team. We also bring KerysCloud simulation technology — a capability few full-service CROs can match.
An ICH E9(R1)-compliant SAP includes: the estimand framework (treatment regimen, population, variable, intercurrent events, population-level summary), primary and secondary analysis methods, handling of missing data, sensitivity analyses, subgroup analyses, multiplicity adjustment strategies, and analysis dataset specifications. MMS SAPs are written to minimise agency queries and align with current FDA and EMA statistical guidance.
Adaptive trial designs allow pre-specified modifications to a trial in progress — such as sample size re-estimation, arm dropping, or dose selection — based on accumulating data. KerysCloud simulation enables sponsors to evaluate thousands of scenarios before a trial starts, quantifying the operating characteristics of adaptive rules (type I error, power, expected sample size) and producing regulatory-ready simulation reports to accompany IND/CTA submissions.
Yes. MMS can engage at any point in the clinical development lifecycle — including providing targeted support for a specific deliverable such as a sample size calculation, SAP QC review, ISS/ISE development, or agency response support. We are structured to be flexible partners, not full-programme lock-ins. Contact us to discuss your specific needs.
All MMS statistical deliverables follow current ICH, FDA, and EMA statistical guidance including ICH E9(R1) estimands, FDA adaptive design guidance, and EMA statistical methodology guidance. Our quality assurance process includes independent statistical QC review and structured review against agency-specific expectations. We track agency feedback across our portfolio and update our methodology standards accordingly.
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