MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
MMS Supported MAPS Public Benefit Corporation NDA Submitted to FDA for First Psychedelic-Assisted Therapy for PTSD
Canton, Mich. (December 13, 2023) – MMS, a data-focused Clinical Research Organization (CRO), announced MAPS Public Benefit Corporation (MAPS PBC) submitted a New Drug Application (NDA) to the FDA for MDMA (midomafetamine capsules) used in combination with...
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...
Patient Experience Data: An Important Consideration for FDA Benefit-Risk Assessments
From a drug development perspective, benefit-risk assessments can sometimes feel abstract. However, from a patient's perspective, they are a lived experience with a disease state and therapy. One benefit-risk assessment exists in paper and data, while the other lives...
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...
Good Laboratory Practice (GLP): A Validation Approach
Good Laboratory Practice (GLP) is a quality control system for clinical research laboratories and organizations to ensure the integrity, consistency, and reproducibility of the data within non-clinical and clinical studies of products in development for human or...
Meet These Four Expectations When Shifting SOPs in the Pharmaceutical Industry into Electronic Format
Standard Operating Procedures (SOPs) in the pharmaceutical industry are documents used by an organization to provide step-by-step actions for a specific process. And, according to a published study in ResearchGate, a typical pharmaceutical company must manage an...
FDA REMS Programs: Five Major Components for Compliance
The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
Quality in Clinical Trials Should be Owned by All Departments: Here’s Why
Quality in clinical trials is of utmost importance to the pharmaceutical industry, with the need for quality management systems estimated to grow to $4.5 billion by 2032 according to Global Market Insights. The best pharmaceutical pipelines are driven by good quality...