Drug Safety &
Quality & Compliance
Helping sponsors navigate a complex regulatory environment
MMS is an award-winning, data-focused clinical research organization (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 and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
Industry experts across 4 continents are available to support your programs 24×7 with a 97 percent sponsor satisfaction rating
Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director
Dr. Allen has worked at Parke Davis, Pfizer, Adolor, AstraZeneca, Wyeth, Scirex, Premier, and Inventive/ Syneos. In recent years, he has served as Chief Medical Officer for several start-up companies, including Afferent, Centrexion and Concentric Pharmaceuticals. Read more.
View our upcoming webinar on how to create fit-for-purpose clinical study reports for successful submissions.
A clinical study report (CSR) is an essential building block of a clinical submission. The ICH and FDA provide guidance for the structure and content of CSRs and instances when an abbreviated or synoptic CSR format should be used in place of a full CSR format, depending on the role of the CSR in a submission. Get recording.
MMS Holdings Wins Scrip 2021 Best CRO Award
The Scrip Awards, held annually by London-based Informa Pharma Intelligence, honors outstanding achievements of organizations in the pharmaceutical, biotech and allied industries. The award for Best Contract Research Organization-Specialist Provider recognizes MMS for exceeding Sponsor expectations, bringing innovations to the industry, improving data quality and and streamlining data collection and reporting through the Decentralized Trials and Research Alliance (DTRA). Read more
SUBMISSION SUPPORT FOR PARATEK PHARMACEUTICALS GARNERS FDA APPROVAL AND SUCCESSFUL MAA FILING
MMS supported Paratek Pharmaceuticals, Inc. for the new drug application (NDA) approval and successful marketing authorisation application (MAA) filing of NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). Get the details
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