MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
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...
FREE DOWNLOAD: Lay Summary Whitepaper
This complimentary lay summary whitepaper will explain: the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent. Click on the image for the full...
MMS Holdings Leverages Medrio to Accelerate Clinical Trial Process for Study Sponsors Through New Contract
The agreement demonstrates the value of Medrio’s support resources in facilitating mutual success for CROs and study sponsors. SAN FRANCISCO (May 08, 2019) – MMS Holdings – an award-winning, data-focused contract research organization (CRO) – has successfully...
Being Inclusive, the Open Door Policy, and True Success: A Conversation with Diederik Van Niekerk
In this Expert Insights interview, we sit down with our South African leadership, Diederik Van Niekerk, Operations Manager at MMS in Bloemfontein, South Africa, to discuss his detailed approach for effective team-building, his views on work/life balance, and growth....
Part 4: The Case for Better Health History Records – Overcoming Barriers to Medical Records Access
In Part 3 of this medical histories series, the focus centered on defining many of the barriers that clinical investigators face when attempting to procure adequate medical records for subject eligibility determination. While the list of potential issues appeared...