Clinical Development in Europe

Early development decisions can create significant downstream regulatory and operational risk if statistical strategy is introduced too late. MMS provides statistical advisory services supporting sponsors with study design and protocol development, estimand strategy, adaptive trial design, Bayesian methods, simulation-based planning, and statistical analysis plan authorship. Statisticians are involved from early development through to submission, to ensure continuity.

For European programs, this includes alignment with ICH E9(R1) estimand guidance as implemented by EMA, and familiarity with EMA Scientific Advice processes for statistical design questions.

https://mmsholdings.com/services/statistical-consulting-services/

Data sits at the center of clinical development decision-making. MMS brings biostatistics, statistical programming, data management, and data science together within a single integrated biometrics model designed to improve data quality, reduce operational friction, and provide clearer oversight across the study lifecycle. Datacise® by MMS further supports near real-time data review,  and faster identification of emerging study risks and trends.

https://mmsholdings.com/solutions/full-service-biometrics/

European biotech companies are increasingly balancing regional development requirements with global approval ambitions. Coordinating submissions across EMA, FDA, MHRA, and other agencies can create delays and downstream review risk if evidence, sequencing, and transparency requirements are not aligned early.

MMS provides regulatory strategy and submission leadership across EMA, FDA, MHRA, and Swissmedic interactions, helping sponsors align evidence generation, submission sequencing, and regulatory positioning for parallel or multi-region development programs. This includes MAAs, CTAs, FDA submissions and meetings, Scientific Advice preparation, RMP development, and EU-CTR/CTIS transparency management.

https://mmsholdings.com/services/regulatory-strategy-consulting/

KerusCloud® is a clinical trial simulation platform that allows teams to model virtual trial scenarios before a study begins testing endpoint strategies, sample size assumptions, adaptive design parameters, and recruitment plans in silico. It is built to align with ICH E9(R1) estimand guidance and has been used in programs with EMA regulatory oversight. For indications where per-patient trial costs are high, simulation-based design review is a practical tool for reducing design risk early.

https://mmsholdings.com/ai-technology/keruscloud-clinical-trial-simulation/

Datacise® is a cloud-based clinical data platform that aggregates, curates, and visualises trial data in real time. It supports Data Monitoring Committee (DMC) operations, interim analyses, and ongoing safety review through three integrated applications: Curate, Analyze, and Explore. Real-time data access reduces the latency between data availability and decision-making at critical trial milestones.

https://mmsholdings.com/ai-technology/datacise/

An integrated team covering biostatistics, statistical programming, data management, and data science, operating under a single project structure. Suitable for sponsors who want a single accountable partner for all biometric deliverables across a program or submission.

Defined scope engagements a simulation study using KerusCloud, a statistical analysis plan for a specific trial, an EMA submission package for a single indication. Project-based work is useful for sponsors with specific gaps or for organizations evaluating a partner before a longer engagement.

For programs where a transition between CRO partners is required whether planned or unplanned, MMS has experience managing handover processes, data audits, and rapid mobilisation to keep development timelines on track.

MMS partners with sponsors through an advisory engagement that aligns regulatory strategy and statistical planning from pre‑IND/CTA through submission, reducing avoidable programme risk. We help map expedited pathway options and precedent, then sequence evidence to support key milestones aligning trial design, endpoints and briefing packages for Scientific Advice and downstream submission questions.

MMS supports sponsors with a coordinated FDA and EMA strategy, aligning regulatory and statistical planning from the outset to meet the expectations of both agencies. We help map parallel pathway options and align trial design, endpoints, and evidence generation to support interactions across FDA and EMA, reducing duplication and strengthening consistency. This approach enables more efficient scientific advice, clearer development positioning, and smoother, more synchronised submissions across regions.

A Risk Management Plan (RMP) is an EMA requirement for medicines seeking authorization in the European Union. It is a structured document covering safety specification, the pharmacovigilance plan, and risk minimisation measures, and is subject to ongoing review and update throughout the product lifecycle. A Risk Evaluation and Mitigation Strategy (REMS) is a US FDA mechanism with different structure, scope, and procedural requirements. The two systems address similar objectives but are not equivalent, and development of one does not automatically satisfy the other.

MMS has supported MAAs to EMA, Clinical Trial Applications (CTAs) in EU member states, and MHRA submissions for UK programs. Our regulatory consultants work with European agency guidance as a primary reference, including EMA Scientific Advice processes and MHRA post-authorization requirements.

Parallel development for FDA and EMA is a common program structure. It requires careful coordination of statistical analysis plans, data standards, and submission timelines to account for the different requirements and review cycles of each agency. MMS has experience structuring biometrics and regulatory deliverables for multi-agency programs.

KerusCloud is MMS’s clinical trial simulation platform. It allows teams to model trial scenarios in silico, testing design assumptions, sample size calculations, adaptive decision rules, and recruitment projections before a real study begins. The platform is built to align with ICH E9(R1) estimand guidance, which EMA has adopted as part of its expectations for statistical analysis planning. Simulation-based justification for adaptive designs is an approach EMA is receptive to when the methodology is appropriately documented.

MMS has worked across oncology, rare disease, cell and gene therapy, central nervous system disorders, immunology, pulmonary disease, and others. Specific experience in a given indication or endpoint type is best discussed directly we would rather give you an honest picture of where our depth is strongest than a broad claim that does not reflect the specifics of your program

CTIS is the EU-wide platform through which clinical trial applications, amendments, and results must be submitted for trials conducted in the European Union. It replaced the patchwork of national submission processes that existed previously. Sponsors are responsible for the initial application, for maintaining trial information throughout its conduct, and for submitting results within the required timeframe after trial completion. The process has its own administrative requirements, and organizations managing EU trials for the first time or transitioning from national system experience often benefit from support in setting up and managing CTIS workflows.