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.

03/13/2026

PHUSE US Connect is happening this month! MMS experts will be an integral part of the conversation, as the team is presenting three sessions focused on strengthening collaboration and expanding how data science supports clinical development.

The sessions include:

✅ Building Cross-Functional Regulatory and Programming Alignment for Successful Submissions

✅ Estimand-Aligned Multiple Imputation Strategies in CNS Trials with Complex Intercurrent Events

✅ What Pharma Can Learn from Data Science Outside the Industry

These sessions will be presented by Ben Kaspar, Stephine Keeton, Kris Wenzel, Ian Lees and Veera Thota in an effort to explore how stronger collaboration between regulatory and programming teams improves submission readiness and how lessons from data science outside pharma can expand analytical thinking in clinical development.

View the agenda to plan your day: https://hubs.li/Q046Mp180

Request a meeting or visit the MMS booth onsite: https://hubs.li/Q046MlRW0

03/12/2026

There are just 2 weeks left until we dive deep into early oncology data interpretation! With experts speaking from PAQ Therapeutics, Friends of Cancer Research, and MMS, this session will explore how sponsors can move beyond surface-level outputs and build stronger clinical narratives through disciplined statistical thinking and cross-functional alignment.

Early oncology programs demand clarity around endpoints, interim reads, and totality of evidence. The discussion will focus on how thoughtful interpretation shapes regulatory conversations long before submission.

If you are working in oncology development and want sharper insight into how data drives decisions, REGISTER NOW: https://hubs.li/Q046vSm50

03/11/2026

Twenty years ago, MMS began with a clear belief that data makes the difference and quality should anchor every decision.

Today, we celebrate 20 years of supporting sponsors across regulatory affairs, biometrics, safety, medical writing, and much more. What started as a focused vision has grown into a global team trusted with some of the most complex programs, expedited pathways, and high-stakes submissions globally.

To our colleagues, clients, and partners around the world, thank you for being part of the journey! The next chapter is already in motion.

03/10/2026

What does global submission planning really require? Alignment.

Our latest blog, “Behind the Scenes of Global Regulatory Submission Planning is a Symphony of Collaboration,” explores how regulatory, biometrics, safety, medical writing, and publishing teams work in lockstep to prepare high-quality submissions across regions.

Strong submissions are shaped early through coordinated endpoint strategy, integrated statistical planning, and clear communication across functions. If you are preparing for a global filing, this piece offers a practical look at what it takes for the most seamless submission.

Read more here: https://hubs.li/Q0467TG-0

03/09/2026

We’re proud to share that two MMS leaders will be speaking at ACDM 2026 this year in Berlin!

1️⃣ On March 16, Doreen Van Huyssteen will present “Risk Based Data Management Success Factors and Associated Risks.,” and her session will explore how RBQM continues to shift data oversight from uniform review models to more targeted, risk-informed approaches, and what organizations must consider to implement it effectively.

2️⃣Later that day, Minya Engelbrecht will lead a session on “Clinical Data Management Soft Skill Utilization; Translating Neuro-Linguistic Programming into Higher Customer Satisfaction,” and her talk will examine how communication, mindset, and behavioral insight influence sponsor relationships and operational outcomes.

ACDM 2026 continues to bring together leaders shaping the future of clinical data management, and we look forward to the discussions ahead! If you’re attending, message our team to connect onsite: https://hubs.li/Q045_TJ60

View the entire agenda here: https://hubs.li/Q045_Swp0

03/06/2026

MMS will be attending the RIC Annual Meeting 2026 next week in Arlington, Virginia.
Hosted by the REMS Industry Consortium, the RIC Annual Meeting brings together REMS professionals, regulators, sponsors, and industry partners to collaborate on best practices, standardisation, and innovation across REMS programmes all with a shared focus on advancing patient safety and appropriate access to medicines.

Our team will be on site on 11–12 March at the Westin Arlington, taking part in discussions around REMS modernisation, regulatory expectations, and the evolving risk management landscape.

If you’re attending RIC 2026, feel free to connect with:
Somya Dunn, Senior Medical Director, Safety Risk Management
Mark Bernath, Director, Business Development
Christine Manley, Director, REMS & Pharmacovigilance

We’re looking forward to engaging conversations and connecting with peers across the REMS community!

03/05/2026

We are proud to announce our latest webinar with PharmaIgnite and Scrip, focusing on Making the Right Decisions with Incomplete Evidence in Early-Phase Oncology Trials! Panellists spanning statistical design, in-stream data interpretation, endpoint strategy, and decision architecture will look at how early-phase oncology teams make and justify in-study decisions at speed when evidence is incomplete, and how to distinguish signal from noise to move forward responsibly.

Moderated by Ben Dudley, Chief Commercial Officer at MMS, thought leaders on this panel include:

➡️ Andrew Krivoshik, MD, PhD, PE, Chief Medical Officer at PAQ Therapeutics
➡️ Mark Stewart, PhD, Vice President of Science Policy at Friends of Cancer Research
➡️ Aiden Flynn, PhD, Senior Vice President, Strategic Statistical Services at MMS

Join us later this month and reserve your spot now: https://hubs.li/Q045KzMz0

03/04/2026

Have you wanted to engage in Bayesian statistics? In recent pediatric work, MMS employed Bayesian dynamic borrowing and simulation-guided design to validate pediatric efficacy using adult clinical trial data.

And, we created a downloadable case study to tell you how it all worked! Read it now to understand how:

✅ Bayesian extrapolation can bridge adult + pediatric data
✅ KerusCloud® simulations assess feasibility and success probabilities
✅ Dynamic borrowing improves precision and reduces reliance on underpowered data
✅ We delivered a regulatory‑ready analysis aligned with submission timelines

Download the case study now: https://hubs.li/Q045x-Zw0

03/02/2026

Have sponsors gained traction with the Commissioner’s National Priority Voucher and what does application readiness really require? This question comes straight from our recent webinar on expedited regulatory pathways and it is one many sponsors are actively navigating right now!

This short clip offers a practical look at how readiness, evidence strategy, and timing factor into whether programs are positioned to take advantage of priority pathways.

👉 See the full discussion here: https://hubs.li/Q044-TcN0

02/28/2026

At MMS, our dedication goes beyond raising awareness, we are committed to driving treatment breakthroughs and research innovation for rare diseases. Today, on Rare Disease Day, our global teams stand with the 300 million+ people worldwide affected by rare conditions. While each disease may be rare, together they represent a significant global community, including 30 million+ Americans.

Over the past decade, MMS has supported programmes across a wide range of rare diseases, including Duchenne Muscular Dystrophy, Hereditary Angioedema, Myasthenia Gravis, and Sickle Cell Anemia. Our ongoing commitment to rare disease development is strengthened through active participation in the scientific and regulatory community, continuous learning from advances in science and guidance, and the use of real‑world evidence to help sponsors navigate complex regulatory and development challenges globally.

02/27/2026

The 4th Annual COG UK conference kicks off next week, and London will be at the centre of some timely conversations on clinical operations and delivery.

Hosted by The PBC Group, this event brings together leaders focused on how trials are executed in practice, from operational strategy to oversight and decision-making. We’re pleased that our Chief Commercial Officer Ben Dudley will be speaking, about 3 technology use cases that have advanced clinical development programs.

Request an on-site meeting with our team: https://hubs.li/Q044ZC6f0

02/25/2026

MMS is headed to the Psychedelic Therapeutics and Drug Development Conference later this week! We’re looking forward to connecting with industry peers shaping the future of psychedelic development.

Representing MMS on site:
Somya Dunn, Senior Medical Director, Safety Risk Management
Amanda Beaster, Senior Director, Regulatory Strategy
Duane Robinson, Senior Director, Business Development

We’ll also be presenting a poster focused on REMS logic modelling for psychedelic therapies, exploring how mechanism‑specific patient impairment can inform more practical, durable risk mitigation strategies.

If you’re attending and up for a great conversation, reach out to Duane Robinson to set something up. Let’s connect and move the field forward together.

Address

6880 Commerce Boulevard
Canton, MI
48187

Telephone

+17342450310

Website

http://www.mmsholdings.com/

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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.