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Author: Djenan Ganic

FDA TPP – Target Product Profile – Strategic Development Tool for Therapeutic Candidates
February 5, 2021February 10, 2021

FDA TPP – Target Product Profile – Strategic Development Tool for Therapeutic Candidates

Clinical Trials by Djenan Ganic0 comments

One of the tools that we have in Pharma R&D organizations at our disposal to manage strategic development for therapeutics […]

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Digitalized Protocol Eligibility Criteria
January 26, 2021February 10, 2021

Digitalized Protocol Eligibility Criteria

Clinical Trials by Djenan Ganic0 comments

Digitalized Protocol Eligibility Criteria enable both human readability but also immediate use in RWE tools in a digitalized form for […]

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Scaled Agile Framework SAFe in GxP Projects – How can pharma IT benefit?
October 9, 2020February 10, 2021

Scaled Agile Framework SAFe in GxP Projects – How can pharma IT benefit?

GxP by Djenan Ganic0 comments

The digital age and interconnected processes from R&D, supply, and manufacturing are the main topics of Pharma 4.0 which is […]

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Agile Transformation in GxP Systems Implementation
October 7, 2020February 10, 2021

Agile Transformation in GxP Systems Implementation

GxP by Djenan Ganic0 comments

Pharma organizations are slowly but steadily moving into digitization transformation of their business processes [1]. Their corresponding IT organizations are […]

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Digital Clinical Trial Protocol
September 17, 2020February 10, 2021

Digital Clinical Trial Protocol

Clinical Development by Djenan Ganic0 comments

Digital clinical trial protocol in the context of this article represents a digital asset of the sponsor company, that contains […]

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Re-imagine Clinical Development in a New Indication: here is what you need to know?
June 19, 2020June 19, 2020

Re-imagine Clinical Development in a New Indication: here is what you need to know?

Clinical Development by Djenan Ganic0 comments

Over the years, we have experienced challenges for drug development sponsors when extending the clinical development in a new indication. […]

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Keys to Clinical Development Excellence
May 13, 2020May 29, 2020

Keys to Clinical Development Excellence

Clinical Development by Djenan Ganic0 comments

Now, more than ever, It is becoming increasingly more evident that pharma companies in general and clinical development organizations in […]

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Lean Process to Shorten Clinical Study Setup Time, Improve Productivity and Get Your Product to Market Faster
November 7, 2019November 7, 2019

Lean Process to Shorten Clinical Study Setup Time, Improve Productivity and Get Your Product to Market Faster

Clinical Development by Djenan Ganic0 comments

I am sure the readers would agree that productivity is the result of a commitment to excellence, intelligent planning, and […]

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Optimize Target Product Profile – TPP : Pharma R&D Strategy
July 9, 2019July 9, 2019

Optimize Target Product Profile – TPP : Pharma R&D Strategy

Pharma R&D by Djenan Ganic0 comments

An effective product portfolio strategy for any R&D organization must include strategies to optimize Target Product Profile – TPP of […]

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Digital Transformation in Clinical Trials
June 15, 2019July 2, 2019

Digital Transformation in Clinical Trials

Clinical Trials by Djenan Ganic0 comments

It is becoming increasingly more evident that pharma companies clinical development organization must invest in digital transformation in clinical trials […]

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  • FDA TPP – Target Product Profile – Strategic Development Tool for Therapeutic Candidates
  • Digitalized Protocol Eligibility Criteria
  • Scaled Agile Framework SAFe in GxP Projects – How can pharma IT benefit?
  • Agile Transformation in GxP Systems Implementation
  • Digital Clinical Trial Protocol

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