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Category Archives: Volume 10 Issue 3

FDA Focuses On Innovative Trial Designs

Volume 10 Issue 3By flabio55th June 2018

The US Food and Drug Administration (FDA) is seeking stakeholder input on the use of complex innovative designs (CIDs) in…

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How Far Can AI Go in Life Sciences?

Volume 10 Issue 3By flabio55th June 2018

Artificial intelligence (AI) and machine learning are everywhere; intelligent internet and content searches that adapt to user preferences, automated personal…

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Respiratory Network for Early-phase Clinical Trials

Volume 10 Issue 3By flabio55th June 2018

The biopharmaceutical industry has a growing need for early-phase clinical studies in respiratory patients to support more advanced and informed…

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

Volume 10 Issue 3By flabio55th June 2018

Gene therapy clinical trials differ in notable ways from other kinds of clinical trials. For one thing, patients in a…

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Implementation of ICH E6 R2 – An Overview of Key Changes

Volume 10 Issue 3By flabio55th June 2018

After release of the final draft of ICH E6 R2 in November 2016, the regulatory bodies started announcing the implementation…

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

Volume 10 Issue 3By flabio55th June 2018

Amidst growing concern that the needs of women are being overlooked by academics and pharmaceutical companies, the FDA’s Office of…

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Central Haemodynamic Assessments Mitigate Risks in Drug Development

Volume 10 Issue 3By flabio55th June 2018

Given high costs and low success rates, risk mitigation strategies are critical in drug development. Pharmaceutical companies and investors are…

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How to Prevent Poor Patient Enrolment from Derailing a Clinical Trial

Volume 10 Issue 3By flabio55th June 2018

A recent study by researchers at McGill University’s Biomedical Ethics Unit found that one in five clinical trials is terminated…

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Staff Turnover: Is Lower Healthier?

Volume 10 Issue 3By flabio55th June 2018

Evgeny Poltanov at Synergy discusses the CRO’s staff turnover and how anyone can guarantee a completely stable team when it…

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Patient-centricity – A Winning Formula

Volume 10 Issue 3By flabio55th June 2018

There has been considerable discussion about the concept of patientcentricity in the pharmaceutical community. The industry has taken a collective…

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