A seemingly simple question regarding the organization’s clinical data strategy reveals one of the still under-utilized opportunities for many pharma […]
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FDA TPP – Target Product Profile – Strategic Development Tool for Therapeutic Candidates
One of the tools that we have in Pharma R&D organizations at our disposal to manage strategic development for therapeutics […]
Digitalized Protocol Eligibility Criteria
Digitalized Protocol Eligibility Criteria enable both human readability but also immediate use in RWE tools in a digitalized form for […]
Scaled Agile Framework SAFe in GxP Projects – How can pharma IT benefit?
The digital age and interconnected processes from R&D, supply, and manufacturing are the main topics of Pharma 4.0 which is […]
Agile Transformation in GxP Systems Implementation
Pharma organizations are slowly but steadily moving into digitization transformation of their business processes [1]. Their corresponding IT organizations are […]
Digital Clinical Trial Protocol
Digital clinical trial protocol in the context of this article represents a digital asset of the sponsor company, that contains […]
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 […]
GxP project consulting in pharma: A service for sustainable GxP transformation
Looking back over several years of delivering GxP project consulting in pharma reveals the underlying benefit of specialized project sub-teams. […]
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 […]
