Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient Reported Outcomes (ePRO) are innovating the clinical trial industry. It’s time for Sponsors to embrace accurate and efficient real-time electronic data collection directly from patients, in the...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Conducting Quantitative Risk Assessments for Anonymized Datasets and Documents: What This Means for Sponsors and Patient Privacy
CANTON, Mich. (10/2/2022) - Data anonymization and document anonymization in clinical trial data is now more important than ever. In recent years, clinical trial data sharing has become a requirement as part of the regulatory process for EMA and Health Canada. It is...
FDA Discusses Considerations for AR and VR Medical Devices: What This Means for Sponsors
Augmented reality (AR) and virtual reality (VR) medical devices are being integrated into the medical field at an accelerating rate. On July 12th and 13th, 2022, the FDA held a Patient Engagement Advisory Committee (PEAC) meeting to consider the capabilities, risks,...
How does the European Union Clinical Trial Information System (EU-CTIS) Affect Clinical Trial Transparency?
On 31 January 2022, the EU Clinical Trial Regulation 536/2014 (commonly known as EU-CTR) replaced the long-standing directive, the European Union (EU) Clinical Trial Directive 2001/20/EC (commonly known as EU‑CTD). There are important changes in the EU-CTR, compared...
Are Pharmaceutical Consultants Worth It? A Case for Why Consultants are Important at Every Stage of the Drug Discovery and Development Process
Consultant – a person who provides expert advice professionally. Drug discovery and development is a team endeavor with significant expertise needed at every stage. This expertise is a challenge for any company to cover completely in-house. With drug discovery and...
How to Achieve Compliance for Feasibility Studies with Digital Health Technologies
Digital Health Technologies (DHTs) are rapidly innovating the health care and pharmaceutical industries. DHTs like mobile medical apps, wearable devices, telehealth and telemedicine have the potential to increase the focus on patients and enhance the delivery of their...
Natural Language Processing in Healthcare: The Pros, Cons, and Potential Impact
Natural language processing (NLP) is a powerful tool revolutionizing how information is collected, stored and used in healthcare and health science. Due to the complexity of data in a healthcare setting, natural language processing is a particularly useful data...
Clinical Trial Disclosures 101: The Basics You Need to Know
As regulations around clinical trial data disclosure continue to increase in complexity, it can be difficult to keep up with the changes. We asked Raina Agarwal, Associate Director of Clinical Trial Disclosure, to give us a class in Clinical Trials 101 to go over the...
Attending the American Chemical Society Central Regional Meeting 2022 – Key Highlights
I attended the American Chemical Society (ACS) Central Regional Meeting - CERM 2022 in person, hosted at Eastern Michigan University in Ypsilanti, Michigan, June 7-10th Attendance was still adversely affected by understandable caution around COVID-19 and flight...