Strategic Consulting

MMS supports clients through the following:

• Clinical development and trial design planning
• End-to-end regulatory strategy and submission preparation
• Advanced statistical modeling and risk assessment
• Cross-functional gap analyses and implementation planning
• Global regulatory pathway evaluation and health authority engagement

View our webinar on innovative trial design and regulatory strategy.

MMS statisticians work closely with regulatory experts to ensure that trial designs are ready to answer key questions and stand up to regulatory review. Through platforms like KerusCloud, MMS provides simulation-guided insight to test different trial scenarios, reduce uncertainty and improve planning.

Our depth of support includes:

• Study design evaluation and protocol development
• Estimand strategy and endpoint planning
• Bayesian modeling and complex statistical methods
• Synthetic control arms and Real-World Data (RWD) integration
• Development plan optimization and investor decision support

Learn how data-focused outsourcing strategies are driving better trial outcomes for sponsors.

MMS provides regulatory guidance starting with early-stage trials through to global marketing applications. The team applies knowledge of precedent and current standards to help Sponsors shape development plans that are clear and aligned with agency expectations. MMS has supported successful submissions to United States Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and other global agencies.

Our depth of support includes:

• Investigational New Drug (IND), New Drug Application (NDA), Biologics License Application (BLA), and Marketing Authorisation Application (MAA) strategy and planning
• Clinical trial application support
• Health authority meeting preparation and representation
• Regulatory gap assessments and roadmap creation
• Strategic content development across modules

Explore insights from our experts on efficiencies for multi-agency submissions.

The same MMS statisticians, regulatory leads, and writers who support planning stay engaged through execution. This continuity helps avoid disconnects, keeps messaging consistent, and strengthens final submissions.

Sponsors choose MMS because they value responsive service, strong scientific support, and a true partnership approach. The MMS team is focused and ready to help you plan and deliver with confidence.

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