MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Psychedelics and Regulatory Considerations Part II: A Shift in Lexicon and Implications of “Nonmedical Use” On Labelling
Recently, there has been a shift in the lexicon for psychedelics in drug development and US Food and Drug Administration (FDA) labelling guidelines. Prescribing information requires precise, accurate descriptions of essential product information to inform healthcare...
Psychedelics in Drug Development and Regulatory Considerations Part I: Benefit-Risk
The systematic study of psychedelics in drug development programs is a relatively recent phenomenon with psychedelics currently under evaluation in clinical trials for the treatment of anxiety, depression, bipolar disorder, epilepsy, obesity, and substance addiction....
Validation of Clinical Dashboards for Decision Making
The PowerBI Dashboard has become the signature tool for clinical data analysis, and the growing dependence on PowerBI’s automated visualization tools has led to the need of dashboard validation. Clinical dashboards are built by ingesting raw data and transforming that...
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....
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...