MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
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....
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FDA Draft Guidance on Demonstrating Substantial Evidence Shines a Light on Confirmatory Evidence in Clinical Trials
The FDA released a draft guidance in September 2023 regarding Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory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...
Computer System Validation Needs Greater Attention When Preparing for an FDA Inspection
Computer system validation (CSV) is a core item that regularly comes up during regulatory inspections. And, the US Food & Drug Administration (FDA) conducted 2,442 inspections in 2022, according to a recent report. To ensure inspection readiness, a two-part series...
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...
Cell and Gene Therapies (CGT): 6 Detailed CMC Considerations for IND Submissions
BackgroundCell and gene therapies (CGT), often referred to as advanced therapeutic medicinal products (ATMPs), are rapidly emerging as favorable treatments, repeatedly targeting rare, ultra‑rare diseases and fall under regulators’ expedited programs [1]. To date, the...
Data Provenance in Real World Evidence Studies, Explained!
Data provenance in Real World Evidence (RWE) studies has quickly becoming an increasing focus in the industry, especially as 90% of pharmaceutical companies today have Real World Evidence teams according to Deloitte. If an audit is underway, for instance, consider an...