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…
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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…
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…
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…
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…
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…
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…
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…
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…
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…