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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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A Closer Look at Compliance and Regulations for Drug Clinical Trials in India

ProRelix Research

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades.

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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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Regulations for Drug Clinical Trials in the USA: Challenges, Opportunities, and What’s Next

ProRelix Research

In the ever-advancing field of pharmaceutical development, regulations surrounding drug clinical trials in the United States serve a critical purpose.

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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

FY2024 Awardees & Observations For the FY2024 Orphan Products Clinical Trials Grants Program, FDA received 51 grant applications and awarded only seven new clinical trials a grant, providing more than $17.2 million to clinical researchers over the next four years to advance the development of medical products for rare diseases.

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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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Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation

PPD

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.