MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
PSI 2024 Ignited Conversations on External Data Sources, Requirements for Estimands, and Bayesian Methodology for Statisticians in Pharma
The PSI 2024 Conference at Beurs van Berlage in Amsterdam, The Netherlands brought statisticians and leaders in the pharmaceutical industry together from across the globe. The energy was invigorating and great conversations were the norm, among the hundreds of...
Industry Veteran Ben Dudley Joins MMS as Chief Commercial Officer (CCO) to Drive Continued Growth for the Data-focused Clinical Research Organization
CANTON, Mich. and READING, UK (July 17, 2024) – MMS, a data-focused clinical research organization (CRO), announced today that Ben Dudley has been appointed as the company’s new Chief Commercial Officer (CCO). Based in the UK, Ben Dudley brings more than 25 years of...
Key Steps to Successful CMC Authoring of IND and IMPD Submissions
Chemistry, Manufacturing and Controls (CMC) is an integral aspect of any drug candidate development and is critical for ensuring protection of the clinical trial subjects. CMC includes information such as the physiochemical or biological properties of a molecule, its...
Managing RTOR Submissions: How to Run a Successful Race from the Top Line Starting Line
The Oncology Center of Excellence (OCE) Real-time Oncology review (RTOR) Pilot program was initiated in February 2018, specifically for supplemental oncology new drug applications (NDA)s and biologic license applications (BLAs) of previously approved drug products....
Part 1: RWD Noninterventional Study Design and FDA Engagement Opportunity for Early Stage Oncology
Since 2018 when the US Food & Drug Administration (FDA) first published a real-world evidence (RWE) program framework, there has been a clear trend toward pharmaceutical companies utilizing real-world data (RWD) as RWE to support regulatory objectives. While the...
Peer-Reviewed Journal Articles: The Crucial Role of Publication in the Pharmaceutical Industry
Peer-reviewed journal articles hold a level of importance to the scientific community that cannot be understated. The pharmaceutical industry and healthcare sector, in general, play a pivotal role in maintaining people’s well‑being and improving their quality of life....
A Structured Approach to Benefit-Risk Assessment Throughout Product Development in the Pharmaceutical Industry
Many of the important decisions that sponsors must make during the drug development lifecycle are based on informed benefit-risk assessments. With the assessments serving a critical role, it is imperative that sponsors understand methodologies and considerations of...
Datacise and Diversity in Patient Enrollment: Combining Geospatial and Demographic Data to Aid Site Selection
Clinical trials play a pivotal role in advancing medical knowledge, evaluating the safety and efficacy of various medical products. However, achieving diversity among clinical trial participants remains a challenge, especially with underrepresentation of certain...
Confined Deferrals in Clinical Trial Applications: Anticipating the Revised EU CTR Transparency Rules
Clinical trial deferrals are a growing topic among those in the transparency niche of the pharmaceutical industry, especially as all new and ongoing clinical trials within the European Union (EU) must now be uploaded to the Clinical Trial Information System (CTIS)...