Canton, Mich. (March 5, 2024) –MMS Holdings Inc, a distinguished global Clinical Research Organization (CRO), stands at the forefront of supporting pharmaceutical and biotech companies, along with numerous smaller enterprises, across a comprehensive range of services. With an impressive track record of successfully completing over 50 submissions for drug approval in the past five years, MMS has solidified its position as the preferred choice for sponsors seeking innovation and unwavering quality from their CRO partners.
Dr. Uma Sharma, CEO of MMS Holdings Inc spoke exclusively to CIO Bulletin about how she and her team of experts are empowering clients in the development and marketing of life-changing therapies, ultimately making a positive impact on patients’ lives on a global scale.
Interview Highlights
What was the motivation behind starting MMS Holdings Inc? How has the company evolved since its founding? How has MMS transformed from a one-person consultancy into a global, data focused CRO since its inception?Interview Highlights
MMS Holdings Inc was founded with the visionary goal of revolutionizing clinical research and infusing a Sense of Urgency and Leadership (SOUL) into drug development. MMS set out to proficiently manage complex clinical trial and health data, with a particular focus on pharmaceutical and biotech entities. This aspiration stemmed from recognizing that the most critical aspect of a clinical program lies in “the data.” MMS aimed to redefine industry standards by emphasizing quality deliverables, strategic pivots, and operational agility as cornerstones of successful drug development.
Since inception, MMS Holdings has undergone remarkable growth, transforming from a single-person consultancy into a globally recognized Clinical Research Organization (CRO). This evolution is characterized by expanding service offerings, significant advancements in AI-driven technology, and cultivating a robust scientific SOUL with over 1000 dedicated professionals. MMS’s global strategic leadership, efficiency-driving innovations, and unwavering commitment to staying abreast of regulatory guidelines and client needs have positioned it as a leader in the data space.
Furthermore, we have excelled in delivering strategies and operational elements to large, mid-size, and emerging biotech companies across established and niche indications, including rare diseases and psychedelics. Consistent innovation has propelled organic growth, solidifying MMS’s status as a global, data-focused CRO. This growth is a testament to MMS’s adaptability, visionary leadership, strong company culture, and unwavering pursuit of excellence.
As a global, data-focused CRO, our company continues to exhibit adaptability, visionary leadership, a strong company culture, and an unwavering pursuit of excellence. The company strategically positions itself as an effective partner for drug development, catering to large pharma, small and mid-size, and emerging biotech companies by expanding its capabilities to meet evolving market demands. This transformative journey underscores MMS’s commitment to its founding mission and solidifies its role as a pioneer in bringing new therapies to market.
Can you outline the primary products and services offered by MMS Holdings Inc. in the regulatory compliance and data services domain?
MMS Holdings Inc. stands as a premier “data center of excellence,” offering comprehensive services to its pharma and biotech sponsors. From global regulatory strategy to study design and execution of all data elements in a clinical development program, MMS provides a one-stop solution. Our extensive biometrics services encompass Statistics, Data management, and Clinical programming, complemented by top-tier medical/regulatory writing. Safety services, including traditional case processing, PV surveillance, signal detection, DSMB, and REMS expertise, ensure a holistic approach.
Starting from Phase 2 data and progressing through marketing applications (NDA/BLA), MMS holds a reputable track record with global regulatory agencies, particularly excelling in securing approvals for new indications. As active participants in industry standards through consortiums like PHUSE and CDISC, MMS’s biometrics services stay current with regulatory requirements. Our leaders contribute to forums, applying advanced statistical techniques and programming skills to derive meaningful insights from complex data, including real-world data (RWD/RWE).
Renowned for clarity, compliance, and comprehensiveness, our medical writing services seamlessly integrate various deliverables for a robust regulatory submission. Rigorous quality assurance processes ensure the highest standards of accuracy and reliability. Constant innovation is a hallmark at MMS, introducing proprietary technology solutions like PVantage™, REMMSurvey™, and Datacise® for added efficiencies and rigor. Embracing technological advancements, our pharmacovigilance services leverage AI to enhance safety reporting and signal detection, emphasizing our commitment to cutting-edge technology for improved drug safety monitoring.
In essence, our commitment to technological innovation is integral, propelling us to provide state-of-the-art solutions in regulatory compliance and data-centric applications, setting new standards for optimized clinical development.
Are there any specific features or methodologies within your offerings that you believe distinguish MMS from other service providers?
MMS Holdings excels in the CRO industry with our innovative Data Acceleration Model, uniquely integrating clinical operations and data services for a comprehensive solution to complex clinical research challenges. Designed to speed up drug development, it ensures efficient clinical trial execution while maintaining our Data center of excellence.
Our strength lies in offering customizable solutions tailored to specific client needs, combining flexibility with advanced technology, positioning us at the forefront of CRO solutions. Our team’s profound understanding of global regulatory requirements, averaging 8-10 new drug applications annually, further distinguishes MMS.
The SOUL philosophy is integral to our ethos, driving global operations with emphasis on urgency, proactive risk management, and a solutions-oriented approach at every level. This mindset empowers teams to be solution-focused, addressing current challenges and anticipating future needs.
In conclusion, MMS Holdings stands out in the CRO industry with our Data Acceleration Model, customizable solutions, AI-led technological advancements, global regulatory insights, and the SOUL philosophy. These factors contribute to high colleague retention rates and customer satisfaction scores, distinguishing us in the industry. Our proprietary Service Management Framework ensures Operational Excellence in service delivery, reinforcing our commitment to maintaining the highest standards.
Can you share specific case studies or success stories where MMS Holdings’ products or services made a significant impact on a client’s project or regulatory compliance process?
MMS Holdings has showcased its expertise through two notable case studies – the TOGETHER Trial and the successful New Drug Application (NDA) for a psychedelic-assisted therapy for PTSD.
In the TOGETHER Trial, MMS designed an Electronic Data Capture (EDC) system for multiple treatment arms, managing over 800,000 pages, 5.5 million data points, and 800,000 queries. This trial, addressing challenging Covid-19 treatment paradigms, earned the prestigious David Sackett Trial of the Year Award.
MMS has a history of supporting groundbreaking NDAs, including MDMA for PTSD treatment. Navigating data and regulatory complexities, our team’s success in developing a first-ever psychedelic-assisted therapy in over two decades reinforces our industry leadership.
Beyond project influence, MMS collaborates with the FDA, recently partnering at a PHUSE event to discuss data provenance in real-world evidence (RWE) studies. This ‘fingerprint’ for data helps researchers trace information in the face of increased data volume. https://advance.phuse.global/pages/viewpage.action?pageId=88703022
These examples showcase MMS’s prowess in handling challenges, offering innovative solutions, and advancing clinical research. As a pioneer in data, technology, and standards in drug development, MMS continues to make impactful contributions.
What are the upcoming goals and initiatives for MMS Holdings, considering its track record of success and industry recognition?
In the ever-evolving landscape of drug development and Pharma, challenges posed by regulators and commercial pricing pressures are escalating. The shift from a predominantly US-centric market to a global one reflects the growing demand for the latest and best treatment options worldwide. The imperative for speed and quality in achieving successful new drug approvals is paramount, with the FDA leading as the primary regulatory authority, incorporating innovative techniques like CRISPR and the utilization of Real-World Evidence (RWE).
MMS maintains its unwavering commitment to its value proposition by continually developing tech tools for services and leading the industry from a regulatory standpoint for new therapies. Our focus extends to expanding Artificial Intelligence (AI) capabilities, covering data analysis, automation processes, and overall clinical trial efficiency in both efficacy and safety realms. This encompasses automation in writing, expedited strategic regulatory insights using AI technologies, and common automation within biometrics processes. Deepening our integration of AI into operations keeps us at the forefront of innovation, optimizing drug development timelines and expediting the speed at which treatments reach the market.
Our commitment to technological advances aims to enhance efficiencies, minimize manual errors, and facilitate the integration of diverse data sources for meaningful and accurate clinical trial outcomes. Additionally, MMS maintains a focus on environmental sustainability, guided by principles such as EcoVadis, while prioritizing a global culture of excellence. Recognized as Best Places to Work across all four continents through colleague survey-led certifications, our dedication to maintaining a positive work environment remains paramount.
Aligned with our mission and SOUL philosophy to redefine industry standards, MMS is steadfast in enhancing patient outcomes through scientific rigor and technological advancements, solidifying our position as a leader in the Clinical Research Organization (CRO) industry.
Is there anything else you want us to highlight that we might have missed?
As a data-focused CRO, we bring significant value to sponsors by effectively supporting their bundled data service needs using proprietary tech tools like Datacise® (curating, analyzing, and visualizing large, unstructured data), PVantage™ (drug safety platform for processing, analyzing, and reporting adverse events), and REMSsurvey (a proprietary tool for REMS compliance), among others. Recognizing data as our clients’ most valuable asset, we leverage it effectively for maximum value.
MMS consistently supports 8-10 new drug applications annually, ensuring successful approvals for sponsors across diverse therapeutic areas, including groundbreaking efforts like psychedelic-assisted therapy for PTSD.
Our global staff retention rates and client satisfaction scores further reinforce our position as value-added partners. At the forefront of AI and tech, the efficiencies we bring to service deliverables like protocols, clinical study reports, datasets, and REMS are unparalleled in the industry. Committed to community well-being, our staff contributes company-paid volunteer hours to support local efforts, extending to pro-bono submissions for underserved patient groups with ultra-rare diseases.
Tech-enabling our services, we use highly configurable proprietary tools designed to accelerate time-to-market, bring tangible efficiencies, and maintain high-quality deliverables. This approach not only enhances our service offerings but also ensures adaptability and responsiveness to evolving client needs, solidifying our leadership in the CRO industry.
Dr. Uma Sharma | Founder & CEO
Dr. Uma Sharma, a visionary leader in drug development, leveraged her early career success as a global lead for Lyrica®, a highly successful pain blockbuster. With extensive work in 57 countries alongside global regulators and scientists, Uma’s vision at MMS aimed to extend that success to other ventures. Over the past 17 years, she has led over 80 NDAs/BLAs to successful approvals, fostering a nimble and dynamic work culture across four global regions.
Recognized as the EY Entrepreneur of the Year (‘20) and other accolades, Uma actively empowers teams to make MMS the “Best in Class for clinical data services.” Passionate about technological and scientific advances, she merges both for effective solutions in the pharmaceutical industry. Under her guidance, MMS has developed proprietary tools like Datacise®, establishing the company as a valuable CRO partner.
“Our Data Acceleration Model, coupled with a SOUL philosophy, positions MMS Holdings at the forefront of CRO solutions, driving efficiency, adaptability, and excellence in drug development.”
Media Contact
Prasad Babu
media@mmsholdings.com
