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.

We’re attending the 21st Clinical Trials Strategic Summit (CTSS) Boston!If you’ll be there, we’d welcome the opportunity...
04/21/2026

We’re attending the 21st Clinical Trials Strategic Summit (CTSS) Boston!

If you’ll be there, we’d welcome the opportunity to connect and exchange perspectives on clinical development, trial strategy, and evidence‑driven decision‑making. Get in touch to arrange a meeting: https://hubs.li/Q04cTzWS0

04/21/2026

Celebrating MMS' 20th birthday, Amanda Beaster, Senior Director of Regulatory Strategy, discusses her 14-year career at MMS, driven by teamwork, continuous improvement, and the knowledge that patients are waiting for the therapies we help bring forward.

Learn more about MMS' people-first, data-led drug development: https://hubs.li/Q04cHzGJ0

We loved taking time to celebrate with our colleagues in India as part of MMS’s 20 year anniversary, a milestone that re...
04/21/2026

We loved taking time to celebrate with our colleagues in India as part of MMS’s 20 year anniversary, a milestone that reflects the people, partnerships, and shared values behind everything we do.

Moments like these highlight the culture, community, and global connection that underpin our team, and the diverse perspectives that continue to strengthen how we work together across regions.

As we continue marking this milestone around the world, we’re already looking forward to our next 20 year celebration in Belfast this May.

Learn more about MMS' 20 years of success: https://hubs.li/Q04cHt7W0

When essential medicines appear on the FDA drug shortage list again and again, it signals more than temporary disruption...
04/20/2026

When essential medicines appear on the FDA drug shortage list again and again, it signals more than temporary disruption.

Uma Sharma, Founder and CEO of MMS, reflects on what persistent shortages of essential medicines reveal about deeper structural weaknesses in the US drug supply chain, and why treating them as episodic misses the bigger risk.

Read the blog: https://hubs.ly/Q04cHzgZ0

04/17/2026

The FDA’s Bayesian Methods Guidance clearly signals openness to Bayesian approaches across a wide range of scenarios, while also setting expectations for how sponsors should approach them.

In this video, Jamie Inshaw explains:
- How the guidance outlines best practices to improve alignment between sponsors and regulators on Bayesian designs
- Why protocol level pre specification is essential, and requires significant upfront work
- An important caveat: following the guidance does not guarantee regulatory agreement, even when best practices are applied

Register for our next webinar to gain insider insights into FDA decision making: https://hubs.li/Q04c5XW30

A strong finish to CMO Summit 360°. Aiden Flynn, Senior Vice President of Statistical Consulting at MMS, took part in th...
04/16/2026

A strong finish to CMO Summit 360°. Aiden Flynn, Senior Vice President of Statistical Consulting at MMS, took part in the “Strategies to Accelerate Time to Inflection Point” panel, sharing practical perspectives on generating decision‑ready clinical data within real‑world constraints.

Watch Aiden’s recent webinar 'Making the Right Decisions With Incomplete Evidence in Early-Phase Oncology Trials' for further insights: https://hubs.li/Q04cj40Z0

Risk evaluation and mitigation strategies can create real regulatory challenges when they’re misunderstood or not fully ...
04/15/2026

Risk evaluation and mitigation strategies can create real regulatory challenges when they’re misunderstood or not fully aligned with development strategy. In our webinar, Inside FDA REMS Decision‑Making: A Fireside Chat for Sponsors, former FDA and MMS experts share practical insight into how REMS are reviewed, designed, and applied from an agency perspective.

Join us to better understand common REMS misconceptions and learn how to approach REMS planning with greater clarity and confidence.

Register here: https://hubs.li/Q04bVJ5b0

We’re pleased to be attending CMO Summit 360°. Aiden Flynn, Senior Vice President of Statistical Consulting at MMS, will...
04/12/2026

We’re pleased to be attending CMO Summit 360°. Aiden Flynn, Senior Vice President of Statistical Consulting at MMS, will take part in ‘Strategies to Accelerate Time to Inflection Point’, a panel discussion addressing challenges CMOs face in generating the most valuable clinical data within constrained timelines and budgets.

If you’re attending, we’d welcome the opportunity to connect at Booth 24 and discuss how sponsors are navigating complex development decisions across today’s clinical landscape.

Learn more: https://hubs.li/Q04bpsFq0

Clinical trial transparency expectations continue to change, and staying compliant is only part of the challenge.In this...
04/10/2026

Clinical trial transparency expectations continue to change, and staying compliant is only part of the challenge.

In this blog, our experts break down the latest transparency updates, why regulators are tightening requirements, and what sponsors should be thinking about now to reduce risk and maintain trust throughout the trial lifecycle.

Read the full perspective: https://hubs.li/Q04bnVqL0

In this blog, Shawn Lantz, Senior Clinical Trial Transparency Specialist at MMS, reflects on an unconventional journey i...
04/10/2026

In this blog, Shawn Lantz, Senior Clinical Trial Transparency Specialist at MMS, reflects on an unconventional journey into the field of clinical trial transparency and the four pillars that shaped their success: strong mentorship, the right technical and soft skills, staying grounded in the who and why of disclosure, and embracing opportunity as regulations and expectations evolve.

Read the full blog: https://hubs.li/Q04bl7rJ0

As AI use accelerates across clinical development, the question isn’t how fast we automate, but how we maintain control,...
04/09/2026

As AI use accelerates across clinical development, the question isn’t how fast we automate, but how we maintain control, accountability, and trust in regulated environments.

In AI Governance in Pharma: Why Human Oversight Still Matters, MMS explores why strong governance frameworks and human judgment, remain essential to responsible, regulator ready AI adoption.

Click here to read the blog: https://hubs.li/Q04b8r0P0

Risk evaluation and mitigation strategies can introduce significant regulatory risk if they’re misunderstood or poorly a...
04/08/2026

Risk evaluation and mitigation strategies can introduce significant regulatory risk if they’re misunderstood or poorly aligned with development strategy. In our upcoming webinar, Inside FDA REMS Decision‑Making: A Fireside Chat for Sponsors, former FDA and MMS experts share practical insight into how REMS are evaluated, designed, and applied from an agency perspective.

Join us to gain clarity on common REMS misconceptions and how to approach REMS planning with greater confidence.

Register here: https://hubs.li/Q049_cF-0

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6880 Commerce Boulevard
Canton, MI
48187

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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.