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which-protocol
Editorial Archive

Which Protocol Should I Use: The Standard ICH E14 Thorough QT/QTc Study or Concentration-effect Modelling?

We now have two methods to fulfill the regulatory requirement to thoroughly evaluate ECG effects of new drugs. Superficially, the CEM approach may seem preferable …

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india
Editorial Archive

India, Once Again the Jewel in the Clinical Trial Crown

India is the seventh largest country in the world by total area, with the second highest population at 1.2 billion, and is bordered by the …

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mitigating
Editorial Archive

Mitigating Risks of Block-enrolled Ophthalmology Studies

The use of block enrolment in ophthalmology trials helps enrolment keep up with the speed of these studies. However, the challenges inherent in their successful …

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the-comprehensive
Editorial Archive

The Comprehensive in Vitro Proarrhythmia Assay

The focus of the comprehensive in vitro proarrhythmia assay (CiPA) is on delayed repolarisation and Torsades de Pointes (TdP) proarrhythmia, a rare but potentially lethal …

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cardio-oncology
Editorial Archive

Cardio-oncology: Safeguarding the Cardiovascular Safety of Anti-cancer Therapies

The ratification of the E14 guideline in May 2005 by the ICH steering committee presented the first major safety guidance adopted by a global regulatory …

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clinical-research
Editorial Archive

Clinical Research Association: A Leading Civil Society Organisation in Turkey

As can be seen in all areas, civil society organisations and initiatives are of key importance in clinical research. In order to translate the ideas …

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medical-management
Editorial Archive

Medical Management in Clinical Trials: A Roadmap to Operational Excellence (Part 4 – Close-out Phase)

Being the final feature of this four-part series of medical management of clinical trials, Mohamed El Malt, MD,PhD, Vijayanand Rajendran, MD and Kelechi K. Olu …

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outcomes
Editorial Archive

Outcomes of International Trials Can Be Affected by Poorquality Translations

Quality in translation is important. Everybody knows that. In this piece, Simon Andriesen, founder and CEO of MediLingua, will show you how to stay away …

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why-intranasal
Editorial Archive

Why the Intranasal Influenza Vaccine is Not Recommended this Season

Each year, as autumn is well underway, seasonal influenza vaccinations become a topic of conversation for everyone in general and for those with children in …

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sponsors
Editorial Archive

Sponsors and CROs: Closing the Technological Gap in Clinical Trials

Engagement has recently been established as a key concept within clinical trials. This trend has delivered a multitude of benefits for participants, who, rather than …

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