Digital clinical trial protocol in the context of this article represents a digital asset of the sponsor company, that contains […]
Author: Djenan Ganic
Re-imagine Clinical Development in a New Indication: here is what you need to know?
Over the years, we have experienced challenges for drug development sponsors when extending the clinical development in a new indication. […]
Keys to Clinical Development Excellence
Now, more than ever, It is becoming increasingly more evident that pharma companies in general and clinical development organizations in […]
Lean Process to Shorten Clinical Study Setup Time, Improve Productivity and Get Your Product to Market Faster
I am sure the readers would agree that productivity is the result of a commitment to excellence, intelligent planning, and […]
Optimize Target Product Profile – TPP : Pharma R&D Strategy
An effective product portfolio strategy for any R&D organization must include strategies to optimize Target Product Profile – TPP of […]
Digital Transformation in Clinical Trials
It is becoming increasingly more evident that pharma companies clinical development organization must invest in digital transformation in clinical trials […]
Risk Management in Clinical Projects
Implementation methodology of the Risk Management in Clinical Projects requires coordination and integration of the information from several relevant sources. […]
Oracle LSH Consulting for Clinical Data Warehouse Platform
Clinical Data Warehouse – the most valuable asset in pharma company A clinical data warehouse is your company’s central clinical […]
MDR MetaData Repository: From an illusory to a true MDR
During the last CDISC EU Interconnect in Amsterdam 8-9 May 2019, I experienced a confusion among many attendees and even […]
E2E Clinical Data Standardization: Why we fail at the BEGINNING of it?
The Clinical Data Interchange Standards Consortium (CDISC) has, in recent years, released several Therapeutic Area User Guides (TAUGs) ranging from […]
