MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
The Emerging Role of Artificial Intelligence (AI) in Global Medical Writing
Over the past several years, there has been a rapidly growing interest in applying Artificial Intelligence (AI) to nearly all sectors of the life sciences industry, especially in global medical writing. With its use in drug discovery1, clinical trial design2, and...
MMS Hires Pharmaceutical Industry Veteran James Zee for Global Biometrics Leadership in Europe Amid Strong Regional Growth
CANTON, Michigan, and LONDON (April 4, 2024) – MMS, a leading, data-focused clinical research organization (CRO), announced today that the company has expanded its biometrics leadership within European operations by hiring James Zee as Director of Global Statistical...
MMS Holdings Inc – A Data-Centric CRO Powerhouse Reshaping Drug Development on a Global Scale
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....
FDA’s KASA Review Methods Expanding Scope to Include Drug Substances
The US Food and Drug Administration’s (FDA) Knowledge-aided Assessment and Structured Application (KASA) review method is endeavoring to expand into drug substances. This is intended to support and address quality system related challenges that are related to New Drug...
Pharmacovigilance Auditing: Creating the Proper Structure & Tips for Success
Pharmacovigilance auditing is a critical function, as drug safety is a primary concern for pharmaceutical companies throughout the drug development lifecycle and beyond. Yet, the evaluation of drug safety is complicated due to safety monitoring requirements which...
Accelerated the sNDA submission by 2 months with Automation in Narrative Writing
In the dynamic and highly regulated pharmaceutical industry, time is often as critical as the quality of the submissions to health authorities. A leading US-based pharmaceutical company recently encountered a substantial challenge: submitting a Supplemental New Drug...
FDA Draft Guidance on Demonstrating Substantial Evidence Shines a Light on Confirmatory Evidence in Clinical Trials
The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence. They're accepting public feedback on this guidance until December...
Change Management and Preparing for Computerized System Audits is Critical to Ensure Positive Regulatory Inspections
Change management in the pharmaceutical industry is Part 2 in our conversation on computer system validation (CSV). As discussed in Part 1, the increase in the use of automated manufacturing and quality systems is forcing an increased exposure on computer systems...
Clinical Data Science: Five Ways it Evolved from Clinical Data Management
Clinical data science is growing exponentially, as the Bureau of Labor Statistics confirms that the need for data scientists is rising faster than other areas with a 35 percent project growth rate through 2032. And, as the pharmaceutical industry has seen in the last...