MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
MMS Holdings and Sage IT Celebrate 10-Year Relationship with Deep Focus on Intelligent Automation and Bot Development
CANTON, Mich. and FRISCO, Texas (August 1, 2019) – MMS Holdings – an award-winning, data-focused CRO – announced that today marks 10 years of successful partnership with Sage IT—a premier provider, helping companies operationalize their vision through the enhancement...
Using Real World Data in Pharmaceuticals: A Conversation with Chris Hurley
The idea and practice of using real world data in the pharmaceutical industry has driven much conversation as of late. As groups like the Health Analytics Collective begin to bring game-changing methodologies to the marketplace, we sat down with Chris Hurley,...
Partner Spotlight: A Conversation with Julia Computing
As an integral member of the Health Analytics Collective, Julia Computing is seen as the programming language of the future. We sat down with Andrew Claster, Director of Marketing & Communication at Julia Computing to get a sense of what Julia is and where they...
MMS Holdings Launches New Time-Saving Application to Automatically Perform Quality Control and Style Checks for Medical Writers
Automatiqc®, an AI tool designed to improve quality and bring efficiencies to the medical and regulatory writing processAutomatiqc® Automatiqc® is a cloud-based solution that utilizes robotic process automation (RPA), a form of artificial intelligence (AI), to apply...
Developing Treatments for Rare Diseases – Reviewing Recent FDA Draft Guidances
New and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are continually being release. These guidances are...
Eleven Experts Discuss the Leadership Mindset of SOUL
SOUL stands for bringing a Sense Of Urgency and Leadership to work each day. The SOUL of MMS comes to life as project work is completed on time and as risks and solutions are identified proactively. At MMS, each colleague takes responsibility for the success of every...
Dr. Mike Poole Joins the Board of Scientific Advisors at Top Global CRO MMS Holdings
The former Gates Foundation executive is helping redefine the CRO experience.SEATTLE (May 23, 2019) – MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced today the addition of Dr. Mike Poole, MD, FACP to its board of scientific advisors. Currently...
Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning
The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is generally focused on the determination of a safe starting dose in humans, the...
Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway
The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a...