MMS

MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach.

MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for three consecutive years.

02/20/2026

What does it actually look like when statistical strategy plays a pivotal role in a successful expedited approval?

This question came up during our webinar on expedited regulatory pathways, and it gets to the heart of how evidence, design choices, and analysis plans shape regulatory confidence under accelerated timelines.

👉 If you want to see how statistical strategy supports real-world expedited approvals, the full discussion is worth your time: https://hubs.li/Q043ktlW0

Global regulatory submissions succeed when planning and collaboration are aligned early and carried through with the pro...
02/19/2026

Global regulatory submissions succeed when planning and collaboration are aligned early and carried through with the proper discipline! This article explores how sponsors can strengthen submission readiness by bringing regulatory strategy, biometrics, operations, and data together from the start, rather than at the finish line.

Read this recent Perspectives article to get a practical look at how coordinated planning improves clarity, reduces rework, and supports confident interactions with health authorities across regions.

See and share it here: https://hubs.li/Q043kq1t0

Part 2 of our conversation with MMS Founder and CEO Uma Sharma, PhD looks at what has sustained MMS over 20 years of gro...
02/18/2026

Part 2 of our conversation with MMS Founder and CEO Uma Sharma, PhD looks at what has sustained MMS over 20 years of growth and impact.

In this installment, Dr. Sharma reflects on how MMS defines innovation beyond technology, why judgment and scientific clarity matter most when there is no established pathway, and how culture directly influences the quality of evidence delivered to regulators. She also shares why trust from both large pharma and emerging biotech continues to shape MMS’s role in high-stakes programs, and what excites her about the future of drug development.

Plus, see why she says “innovation isn’t a tool. It’s judgment.”

Read Part Two to explore how people, purpose, and disciplined decision-making continue to drive MMS forward: https://hubs.li/Q043kjvj0

02/17/2026

Can questions about surrogate endpoints really be answered using real-world data, or do they always require traditional trial endpoints? That exact question is unpacked in this short clip from our webinar on expedited regulatory pathways.

It highlights where real-world evidence can strengthen decision making and where sponsors still need to proceed carefully. Watch the clip, then dive deeper by watching the full webinar to hear how regulatory, statistical, and data strategy come together in practice.

👉 See the full discussion here: https://hubs.li/Q043k4KM0

This week, the RAPS San Francisco Bay Area Chapter brings together regulatory and clinical development professionals, al...
02/16/2026

This week, the RAPS San Francisco Bay Area Chapter brings together regulatory and clinical development professionals, along with April, Ben, And Aiden from MMS, to join in an in-depth discussion on innovative trial designs and regulatory strategies.

As programs become more complex, the ability to align trial design with regulatory expectations early has a direct impact on speed, quality, and confidence at submission. This event offers a timely forum to exchange perspectives on adaptive designs, evolving regulatory pathways, and evidence strategies that support successful development.

Gain more details and reserve a seat now: https://hubs.li/Q0438T3h0

We are thrilled to announce our participation at the ISCR event! Join us on February 14, 2026, from 09:30 AM to 11:00 AM...
02/13/2026

We are thrilled to announce our participation at the ISCR event! Join us on February 14, 2026, from 09:30 AM to 11:00 AM for an insightful talk by Seema Kaveeshwar, Associate Manager of Regulatory and Medical Writing, during Session 6. Seema will be discussing "Medical Writing for Adaptive Trials in India: Framework and Future" in Track 3 - Medical Writing.

We are excited to be part of the program and look forward to engaging with industry peers. Don't miss it!
We’re also pleased to share that Priya Roy, Manager, Clinical Trial Disclosure and Ashok Kumar, Principal Biostatistician, will be attending the event and are happy to connect with fellow attendees. We look forward to engaging with industry peers - don’t miss it!

Our recent article, “Making Clinical Trial Technology Work in Practice” explores what it takes to turn tools into outcom...
02/12/2026

Our recent article, “Making Clinical Trial Technology Work in Practice” explores what it takes to turn tools into outcomes across modern clinical development. As data volumes grow and trial designs become more complex, success depends on aligning technology with scientific judgment, operational reality, and regulatory expectations.

Read how and where technology adds real value, where it can introduce risk, and how sponsors can use it to support better decisions across trial design, ex*****on, and submission.

Understand the full perspective at https://hubs.li/Q042Pvl_0.

February 11 marks the International Day of Women and Girls in Science. At MMS, we believe that science moves forward whe...
02/11/2026

February 11 marks the International Day of Women and Girls in Science. At MMS, we believe that science moves forward when a variety of voices lead the work. From biostatistics and data science to regulatory strategy, medical writing, and safety, women across MMS drive decisions that shape clinical development and advance patient care.

We are proud to support a culture where curiosity, leadership, and scientific judgment are valued and where women and girls are encouraged to build lasting careers in science. Progress depends on talent, opportunity, and the confidence to lead when the work matters most.

Learn more about our culture: https://hubs.li/Q042F3Ss0

02/10/2026

What are you most looking forward to at OCT West Coast?
MMS' Associate Director, Regulatory Strategy, April Nguyen shares what she’s excited to discuss at this year’s event — from AI and technology transformation, to data and regulatory strategy, innovative trial design, and how MMS partners with sponsors to move their programs forward.

If you’re attending OCT West Coast, we’d love to connect.
📍 Meet the MMS team at Booth 54 to discuss what’s next on your clinical development roadmap, and how expert data, technology, and regulatory insight can make the difference.

02/09/2026

How do sponsors know, or when do sponsors know, if they may be eligible for expedited programs? That question comes up often, and it is at the centre of this short clip from our recent webinar on expedited regulatory pathways.

Understanding eligibility, timing, and evidence expectations can shape development strategy far earlier than many teams expect.

👉 Watch the clip for a focused perspective, and then explore the full webinar for a deeper discussion: https://hubs.li/Q0426jj-0

This month, speakers from MMS, along with other regulatory and clinical development leaders, will gather in the Bay Area...
02/09/2026

This month, speakers from MMS, along with other regulatory and clinical development leaders, will gather in the Bay Area to explore how innovative trial designs are shaping the future of clinical development.

The RAPS San Francisco Bay Area Chapter event, “Innovative Trial Designs and Regulatory Strategies to Advance Clinical Development,” will focus on how sponsors can use smarter design approaches, stronger evidence strategies, and regulatory alignment to move programs forward with confidence.

Events like this are critical as trial complexity increases and expectations around data, adaptability, and regulatory readiness continue to rise.

REGISTER NOW to engage in practical, forward-looking discussions with peers across the regulatory and clinical landscape: https://hubs.li/Q0426k1d0

As MMS marks 20 years, our founder and CEO Uma Sharma, PhD reflects on how a people-first, data-led philosophy shaped th...
02/06/2026

As MMS marks 20 years, our founder and CEO Uma Sharma, PhD reflects on how a people-first, data-led philosophy shaped the company from day one.

In Part 1 of this two-part interview series, Dr. Sharma shares the story behind MMS’s founding, the role of scientific judgement in drug development, and why treating data as a strategic asset continues to matter in complex regulatory decisions. The conversation explores how listening to evidence, challenging assumptions, and partnering closely with sponsors can change outcomes for programs and patients alike.

Plus, see why she says “effective drug development starts with listening.”

Read Part 1 to understand the principles that continue to guide MMS after two decades of impact: https://hubs.li/Q041XYMj0

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Our Story

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards.