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Volume 16 Issue 2
 
FDA Focuses On Innovative Trial Designs
Volume 10 Issue 3

FDA Focuses On Innovative Trial Designs

The US Food and Drug Administration (FDA) is seeking stakeholder input on the use of complex innovative designs (CIDs) in drug development and regulatory decision-mak...
5 June 2018 Volume 10 Issue 3
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How Far Can AI Go in Life Sciences?
Volume 10 Issue 3

How Far Can AI Go in Life Sciences?

Artificial intelligence (AI) and machine learning are everywhere; intelligent internet and content searches that adapt to user preferences, automated personal assista...
5 June 2018 Volume 10 Issue 3
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Respiratory Network for Early-phase Clinical Trials
Volume 10 Issue 3

Respiratory Network for Early-phase Clinical Trials

The biopharmaceutical industry has a growing need for early-phase clinical studies in respiratory patients to support more advanced and informed “go/no-go” decisions ...
5 June 2018 Volume 10 Issue 3
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Stay with Us: Achieving Retention During Long-term Follow-up in Gene Therapy Clinical Trials
Volume 10 Issue 3

Stay with Us: Achieving Retention During Long-term Follow-up in Gene Therapy Clinical Trials

Gene therapy clinical trials differ in notable ways from other kinds of clinical trials. For one thing, patients in a typical Phase III clinical trial usually receive...
5 June 2018 Volume 10 Issue 3
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Implementation of ICH E6 R2 – An Overview of Key Changes
Volume 10 Issue 3

Implementation of ICH E6 R2 – An Overview of Key Changes

After release of the final draft of ICH E6 R2 in November 2016, the regulatory bodies started announcing the implementation of E6 R2 one after the other. This makes t...
5 June 2018 Volume 10 Issue 3
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FDA’s Roadmap to Combat the Gender Gap in Clinical Research
Volume 10 Issue 3

FDA’s Roadmap to Combat the Gender Gap in Clinical Research

Amidst growing concern that the needs of women are being overlooked by academics and pharmaceutical companies, the FDA’s Office of Women’s Health (OWH) has released a...
5 June 2018 Volume 10 Issue 3
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Central Haemodynamic Assessments Mitigate Risks in Drug Development
Volume 10 Issue 3

Central Haemodynamic Assessments Mitigate Risks in Drug Development

Given high costs and low success rates, risk mitigation strategies are critical in drug development. Pharmaceutical companies and investors are continually looking fo...
5 June 2018 Volume 10 Issue 3
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How to Prevent Poor Patient Enrolment from Derailing a Clinical Trial
Volume 10 Issue 3

How to Prevent Poor Patient Enrolment from Derailing a Clinical Trial

A recent study by researchers at McGill University’s Biomedical Ethics Unit found that one in five clinical trials is terminated for failing to recruit enough patient...
5 June 2018 Volume 10 Issue 3
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Staff Turnover: Is Lower Healthier?
Volume 10 Issue 3

Staff Turnover: Is Lower Healthier?

Evgeny Poltanov at Synergy discusses the CRO's staff turnover and how anyone can guarantee a completely stable team when it comes to longer-term trials. He says that ...
5 June 2018 Volume 10 Issue 3
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Patient-centricity – A Winning Formula
Volume 10 Issue 3

Patient-centricity – A Winning Formula

There has been considerable discussion about the concept of patientcentricity in the pharmaceutical community. The industry has taken a collective pause in an effort ...
5 June 2018 Volume 10 Issue 3
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