MMS Holdings

Overview

MMS Holdings is a global, data-focused Clinical Research Organization (CRO) founded in 2006 by Dr. Uma Sharma. With more than 1,000 colleagues worldwide and a presence spanning four continents, MMS supports pharmaceutical, biotech, and medical device sponsors from pre-IND through marketing authorization and post-approval.

Core Services

Biometrics & Data Science

• Full-service biometrics management: CRF design, data build, CSR delivery
• Statistical consulting and biostatistics support
• Data Monitoring Committees (DMCs)
• Data management and statistical programming
• Data science and risk-based data management

Regulatory & Medical Writing

• Regulatory strategy consulting
• Regulatory affairs management
• Expedited regulatory pathways
• Global regulatory operations
• Medical writing and quality control
• Proven track record: zero refusals to file; 50+ marketing applications in past five years

Safety & Risk Management

• Comprehensive pharmacovigilance from Phase 1 through post-approval
• Drug safety and PV services
• Compliance and auditing
• REMS solutions

Therapeutic Expertise

• Specialized knowledge in rare diseases, psychedelics, oncology, radiopharmaceuticals, and CNS disorders
• Support for industry-first and well-researched indications

Technology & Innovation

• Datacise® suite: IDMC management, safety signal detection, data flow management, near real-time data status
• Automatiqc®, PVantage®, KerusCloud® platforms
• AI-driven trial design and analysis capabilities
• 2025 acquisition of Exploristics strengthened simulation-driven development and trial design

Engagement Models

• Full-Service Outsourcing (FSO) and Functional Service Provider (FSP) models available
• Flexible, scalable FSP approach for long- and short-term strategic goals
• CRO transition & rescue solutions

Recognition & Awards

• Best Specialist CRO – Scrip Awards
• Best Data-Focused CRO – GHP Global Excellence Awards
• Excellence in Client Service and Partnership – Fierce CRO Awards
• Data Science Solution of the Year – Data Breakthrough Awards (Datacise®)
• Top Workplace (US and Michigan, multiple years)
• Certified Great Place to Work (India and global regions)

Notable Engagements

• TOGETHER Trial: EDC system designed and maintained by MMS; won Society for Clinical Trial's Trial of the Year Award
• Friends of Cancer Research: Supporting development of decision frameworks for interim overall survival interpretation in oncology
• Gates Ventures / Johnson & Johnson / AD Data Initiative: Data intake, harmonization, and anonymization for 250 million protein measurements across 35,000 biosamples in neurodegenerative disease research