To effectively discuss the topic of Artificial Intelligence AI in Clinical Trials Planning and Design, we need to discus what […]
Author: Djenan Ganic
TransCelerate Common Protocol Template: Considerations for Sponsor Adoption
Assumption on my side is that if you are reading this article, then you probably are familiar with the TransCelerate […]
New Insights On Optimizing Protocol Design Practice To Maximize Development Performance
https://youtube.com/watch?v=1bIPs84LNgs%3Frel%3D0 Part 1 of 4: Ken Getz presentation, sponsored by intilaris LifeSciences titled ‘New Insights on Optimizing Protocol Design Practice […]
Meet ICH Quality Management Goals
ICH E6 (R2) provides meaningful additional guidance. In regards to improving study designs, we’d like to call your attention to […]
Effective use of CDISC Therapeutic Area Data Standards in the study setup
The Clinical Data Interchange Standards Consortium (CDISC) has, in recent years, released several Therapeutic Area User Guides (TAUGs) ranging from […]
Improving Oncology Patient Enrollment
Success of a clinical study relies to big extent on enrolling patients. Nearly 25% of cancer trials fail to enroll […]
Standardized Trial Protocols: Service and Toolkit for generation of trial protocols based on Transcelerate template
The pharma industry is generally considered as an expensive enterprise that requires considerable investments into the R&D activities with virtually […]
Why some pharma companies are more successful than others in converting their research dollars into clinical trials?
The pharma industry is generally considered as an expensive enterprise that requires considerable investments into the R&D activities with virtually […]
Prevent Clinical Study Protocol Amendments
Protocols have become more demanding and complex and as a result more amendments arise. In fact, ‘the majority of clinical […]
Clinical Protocols : Improve your designs and reduce costs
The studies executed by the Tufts Center for the Study of Drug Development (Tufts CSDD), clearly show the dependency between […]
