Solutions

Strategic Consulting

Building Confidence Through Strategy, Data, and Regulatory Insight

We were particularly impressed with the efficiency and dedication of the MMS team and pleasantly surprised to see deliverables for review ahead of agreed upon deadlines in several instances.

Director, Clinical Data

Midsize Pharma

MMS Strategic Consulting brings together regulatory strategy, statistical consulting, and data expertise to support critical decisions across the drug development lifecycle. These consulting services combine regulatory strategy, statistical consulting and data expertise to help Sponsors make confident, evidence-based decisions that reduce risk and improve outcomes.

MMS strategic consultants collaborate across regulatory, clinical, statistical and biometrics functions to ensure that study designs are scientifically sound, operationally feasible and aligned with the expectations of regulators, investors and internal teams. Every engagement is focused on designing thoughtful trials, creating strong development strategies, and building plans that help move programs forward.

Integrated Support That Aligns Science With Strategy

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.

Statistical Consulting That Drives Stronger Trials

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 RWD integration
Development plan optimization and investor decision support

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

Regulatory Strategy That Supports Sound Decision-Making

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 FDA, EMA, MHRA and other global agencies.

Our depth of support includes:

IND, NDA, BLA and 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.

Continuity From Strategy to Execution

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.

Get to know our values.