Modern Tools to Advance Generic Drug Development and Review
Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise,…
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Gene Therapy in Rare Diseases
Many rare diseases are “monogenic” – that is, they are the consequence of a defect in a single gene. Daniel…
Patient Safety Monitoring and Beyond
Whether enabling new approaches to patient safety monitoring and clinical trials, or improving success rates for regulatory submissions, artificial intelligence…
FDA Guidance Recommends Diversity in Clinical Trials, but Can’t Require It
The US Food and Drug Administration (FDA) frequently stress the importance of enrolling diverse patient populations in clinical trials conducted…
Intellectual Property Strategies ‘Crucial’ to Protecting Future of Medical Innovation
Robust intellectual property protection is essential to safeguarding the future of revolutionary biomedical innovations, which transform healthcare for millions of…
The Lay Summary – Remember the Reader
As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a…
Regulations and Recruitment: Challenges and Experiences in Bulgaria
Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical…
eClinical: How One Major BioPharma Company is Embracing the New World of Digital Clinical Research
The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel…
Challenges with Cash Management and Reforecasting Clinical Trials
Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater number…
Pre-clinical Data Analysis Ensuring Relevant First-in-Human Clinical Trials
The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS…