Thought Leadership
Rewriting the Rules of Informed Consent Development with AI
Regardless of the market a clinical trial is being conducted in, getting locally approved informed consent forms (ICFs) consume as much as 12% of a clinical trial budget before it even begins. Each ICF must be clear and delicately balance local regulations and patient...
OpTImize London
Park Plaza London Westminster Bridge 200 Westminster Bridge Road London, England, United Kingdom, SE17UT...
Top 10 Prompts to Ask ChatGPT for Optimizing Clinical Trial Recruitment Strategies
Clinical trial recruitment is a complex process that requires strategic planning and data-driven decision-making. Use these AI-powered prompts to refine your approach and enhance participant engagement....
Trial Interactive Customer Summit, OpTImize
Sheraton Commander Hotel 16 Garden St. Cambridge, MA 02138...
Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology
Digital technologies are reshaping rare disease studies, placing the question of data integrity firmly in the spotlight. In this recap from our C3 Summit Session titled Harnessing the Power of Electronic Clinical Outcomes Assessments (eCOA) Technology, we examine the impact of...
Leveraging Technology and Bridging Gaps for Enhanced Clinical Data Management
Discover how technology-driven solutions are bridging gaps in clinical data management. Learn about challenges, trends, and strategies to enhance efficiency and streamline workflows for successful clinical research....
EU CTR White Paper - Operational Considerations & Challenges
The Clinical Trial Regulation (EU) 536/2014 (CTR) came into effect on January 31, 2022, replacing the previous regulatory framework of the Clinical Trial Directive 2001/20/EC (CTD). This white paper provides an overview of the CTR and its impact on the organizational readiness...
A Conversation with Dr. Elin Haf Davies of Aparito
The rare disease space presents numerous challenges for clinical research and patient data capture. These challenges are only heightened for younger patient populations, where outcome measures and dosages need to be considered appropriately. Join Dr. Elin Haf Davies, Founder &...
Sanofi - The Clinical Translation Centralization Journey in Light of the EUCTR 536/2014
Sanofi centralizes clinical trial translations through GlobalLink and best-in-class AI, MT, and more. ...
3 Translation Methodologies for Life Sciences Documentation
This post outlines three translation methodologies for life sciences documentation, emphasizing their importance due to the complexity and specific needs of clinical documentation translation. It describes standard translation, back translation & reconciliation, and...
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...
