Thought Leadership
5 Ways to Increase Diversity in Medical Product Development
This blog emphasizes the critical need for more inclusive clinical trials, highlighting efforts by regulatory bodies like the FDA to ensure diverse patient representation in clinical research. It outlines the impact of variables like age, genetics, and geography on drug response,...
How TMF Study Owners Can Provide Better TMF Management
This blog post details the role of trial master file (TMF) study owners in ensuring effective TMF management for clinical studies, highlighting their expertise in maintaining ongoing TMF health, inspection readiness, and compliance with regulatory standards, while addressing the...
Language Landscape: Latin America
This post discusses the importance of localizing content for the Latin American market in the pharmaceutical industry, emphasizing the need for tailored translations due to the diverse Spanish dialects and cultural nuances across different countries, and the impact of effective...
How to Choose and Implement a CTMS
A guide for small to mid-sized biotech and medical device companies to select and implement a clinical trial management system (CTMS), discussing considerations for assessing organizational needs, technology roadmaps, vendor evaluation, and final selection to enhance clinical...
How Life Sciences Companies Can Detect Adverse Events on Social Media
An overview of the evolving role of social media in pharmacovigilance (PV) for pharmaceutical companies, highlighting how social media platforms have become crucial sources for adverse event reporting and post-marketing safety information, and outlining the challenges and...
The Summary of Safety and Clinical Performance (SSCP) for Healthcare Professionals and Patients
An overview of the requirements and best practices for creating a Summary of Safety and Clinical Performance (SSCP) under the European Union's medical device regulation (MDR), highlighting the importance of clear, audience-specific communication for healthcare professionals...
Driving Fundamentals: Ensuring an Efficient Clinical Research Process
A discussion on the parallels between teaching driving and managing clinical trials, emphasizing the importance of fundamental practices in both areas. It highlights the need for situational awareness and meticulous attention to processes in clinical research, likening it to the...
What Is A TMF Certified Copy?
This post discusses the concept and importance of certified copies in Trial Master Files (TMFs), explaining the FDA's definition, the need for certified copies as per EMA guidelines, the process of verifying exact copies, what constitutes a validated process, and how to...
Practical Applications of Machine Learning for Clinical Trials
In this blog, you’ll learn more about the business cases for machine learning that offer a clearer path to inspection readiness, as well as greater efficiency, timeliness, and quality in the TMF. You’ll understand the challenges that can be solved by applying machine learning to...
