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Category: Clinical Trials

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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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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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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Risk Management in Clinical Projects
June 12, 2019July 2, 2019

Risk Management in Clinical Projects

Clinical Trials by Djenan Ganic0 comments

Implementation methodology of the Risk Management in Clinical Projects requires coordination and integration of the information from several relevant sources. […]

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Oracle LSH Consulting for Clinical Data Warehouse Platform
June 4, 2019May 29, 2020

Oracle LSH Consulting for Clinical Data Warehouse Platform

Clinical Standards by Djenan Ganic0 comments

Clinical Data Warehouse – the most valuable asset in pharma company A clinical data warehouse is your company’s central clinical […]

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MDR MetaData Repository: From an illusory to a true MDR
May 13, 2019November 21, 2019

MDR MetaData Repository: From an illusory to a true MDR

Clinical Standards by Djenan Ganic0 comments

During the last CDISC EU Interconnect in Amsterdam 8-9 May 2019, I experienced a confusion among many attendees and even […]

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E2E Clinical Data Standardization: Why we fail at the BEGINNING of it?
February 28, 2019June 14, 2019

E2E Clinical Data Standardization: Why we fail at the BEGINNING of it?

Clinical Standards by Djenan Ganic0 comments

The Clinical Data Interchange Standards Consortium (CDISC) has, in recent years, released several Therapeutic Area User Guides (TAUGs) ranging from […]

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Quality by Design in Practice: Structured Drug Development
October 16, 2018November 21, 2019

Quality by Design in Practice: Structured Drug Development

Clinical Study Protocols by Djenan Ganic0 comments

Quality by Design in Practice https://youtube.com/watch?v=h72qVImKMPQ%3Frel%3D0 Quality by Design in Practice is a systematic approach to development that begins with […]

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From Clinical Protocol to CDISC Trial Design
September 11, 2018May 22, 2019

From Clinical Protocol to CDISC Trial Design

Clinical Study Protocols by Djenan Ganic0 comments

Early CDISC Trial Design drives study build. https://www.youtube.com/embed/TTqAsUn2aIY?rel=0

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