Looking back over several years of delivering GxP project consulting in pharma reveals the underlying benefit of specialized project sub-teams. […]
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GMP quality consulting in pharma accelerates validation
The number of regulations is steadily increasing, and compliance efforts allocate more resources and bigger parts of the revenue. GMP […]
GMP compliance consulting in pharma and its price
There is no option for GMP compliance consulting in pharma: Regulations are the law and businesses have to be 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 […]
