---
name: MMS Holdings
slug: mmsholdings
site: cro
website_domain: mmsholdings.com
summary: Data-focused CRO providing full-spectrum biometrics, regulatory submissions, safety & risk management, and therapeutic expertise across oncology, CNS, rare diseases, and psychedelics. Named Best Specialist CRO at the Scrip Awards with zero refusals to file on 50+ marketing applications in five years.
tagline: Data-focused CRO turning complex data into clear decisions for regulatory success.
founded_year: 2006
employee_count_band: 1001-5000
employee_count_label: 1,001–5,000
parent_name: 
parent_slug: 
hq_country: 
tier2_domain_verified: false
updated_at: 2026-08-28T07:04:02.107Z
services_count: 14
modalities_count: 5
indications_count: 5
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# MMS Holdings

Data-focused CRO turning complex data into clear decisions for regulatory success.

Listed on cro.directory.

## Summary

Data-focused CRO providing full-spectrum biometrics, regulatory submissions, safety & risk management, and therapeutic expertise across oncology, CNS, rare diseases, and psychedelics. Named Best Specialist CRO at the Scrip Awards with zero refusals to file on 50+ marketing applications in five years.

## At a glance

- Founded: 2006
- Employees (est.): 1,001–5,000

## Services

- Biostatistics & Statistical Programming
- Data Management & eClinical
- Clinical Operations
- Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Medical Writing
- Pharmacovigilance & Drug Safety
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy

## Modalities

- Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Vaccine
- Radiopharmaceutical

## Indications

- Oncology
- Neurology
- Rare Disease
- Psychiatry
- Infectious Disease

## Locations

- Global headquarters

## Long description

## 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

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_Profile last updated: 2026-08-28T07:04:02.107Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.