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Volume 16 Issue 1
 
Modern Tools to Advance Generic Drug Development and Review
Editorial Archive

Modern Tools to Advance Generic Drug Development and Review

Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise, the manufacturing and packaging sites f...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Gene Therapy in Rare Diseases
Editorial Archive

Gene Therapy in Rare Diseases

Many rare diseases are “monogenic” – that is, they are the consequence of a defect in a single gene. Daniel Mazzolenis and Jozsef Palatka at INC Research/inVentiv Hea...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Patient Safety Monitoring and Beyond
Editorial Archive

Patient Safety Monitoring and Beyond

Whether enabling new approaches to patient safety monitoring and clinical trials, or improving success rates for regulatory submissions, artificial intelligence (AI) ...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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FDA Guidance Recommends Diversity in Clinical Trials, but Can’t Require It
Editorial Archive

FDA Guidance Recommends Diversity in Clinical Trials, but Can’t Require It

The US Food and Drug Administration (FDA) frequently stress the importance of enrolling diverse patient populations in clinical trials conducted to support product ap...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Intellectual Property Strategies ‘Crucial’ to Protecting Future of Medical Innovation
Editorial Archive

Intellectual Property Strategies ‘Crucial’ to Protecting Future of Medical Innovation

Robust intellectual property protection is essential to safeguarding the future of revolutionary biomedical innovations, which transform healthcare for millions of pe...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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The Lay Summary – Remember the Reader
Editorial Archive

The Lay Summary – Remember the Reader

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinica...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Regulations and Recruitment: Challenges and Experiences in Bulgaria
Editorial Archive

Regulations and Recruitment: Challenges and Experiences in Bulgaria

Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical drugs and devices, CRO...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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eClinical: How One Major BioPharma Company is Embracing the New World of Digital Clinical Research
Editorial Archive

eClinical: How One Major BioPharma Company is Embracing the New World of Digital Clinical Research

The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel Bascles and Victoria (Vicky) DiBiaso...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Challenges with Cash Management and Reforecasting Clinical Trials
Editorial Archive

Challenges with Cash Management and Reforecasting Clinical Trials

Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater numbe...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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Pre-clinical Data Analysis Ensuring Relevant First-in-Human Clinical Trials
Editorial Archive

Pre-clinical Data Analysis Ensuring Relevant First-in-Human Clinical Trials

The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS discusses how going ahead with something t...
4 December 2017 Editorial Archive | Volume 9 Issue 6
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