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Advancing and Safeguarding Clinical Research for a Better Tomorrow

Advarra

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research

Advarra

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,

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Navigating Audit Trail Review Regulations in Clinical Research

Quanticate

Understanding and navigating the regulations surrounding audit trail review is essential for all CROs, Biotech’s and Pharma’s to ensure that compliance is maintained, and that auditors and regulators can be reassured that the clinical data meets all the necessary standards.

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Looking for Opportunities to Accelerate Clinical Research in Rare Diseases

LifeSciVC

It could also encourage more investment in the space and make us better partners to regulators and payors alike. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

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Diversity, Equity, and Inclusion in Clinical Research

Advarra

Achieving diversity, equity, and inclusion (DEI) in clinical trials is crucial for producing comprehensive and effective medical research benefitting all communities. DEI ensures clinical research encompasses diverse populations, considering variations in gender, race, ethnicity, socioeconomic status, and more.

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The Power of Worldwide Networks in Data and Safety Monitoring Boards

Advarra

A globally diverse DMC ensures the trial adheres to local regulations while maintaining high ethical standards. This collaborative spirit can lead to developing novel methodologies and strategies for monitoring and evaluating clinical trials, ultimately advancing the field of clinical research.