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Author: Djenan Ganic

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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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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Clinical Standardization Starts With Clinical Protocol
May 22, 2018December 4, 2019

Clinical Standardization Starts With Clinical Protocol

Clinical Study Protocols by Djenan Ganic0 comments

Start your End-to-End standardization from clinical protocol. https://youtube.com/watch?v=Fz6L2HuwzOI%3Frel%3D0

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Agile Clinical Trials Planning and Design
May 15, 2018May 22, 2019

Agile Clinical Trials Planning and Design

Clinical Study Protocols by Djenan Ganic0 comments

Looking to improve the way your clinical trials are planned and designed? https://www.youtube.com/embed/3pDBoBeTOCs?rel=0

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