Clinical Development
Expertise: Clinical Development 98 results
Clinical Development
Breaking Free from SDR and SDV: The Case for Centralized Monitoring
Clinical Development
Breaking Free from SDR and SDV: The Case for Centralized Monitoring
Pharmacovigilance is a critical pathway to successful drug development. This pathway helps identify the risks of a product and understand the safety profile, thereby allowing sponsors to balance risks with the benefits while safeguarding patients. Outsourcing this part of the...
Clinical Development
Ana Gonzalez-Santis, Ph.D., PMP
Clinical Development
Amplifying Patient Voices: The Impact of Advocacy Groups in Clinical Trials
In the realm of clinical trials, patient involvement is not just a nicety—it's a necessity. The patient voice has become central to the success of clinical trials, shifting the focus from traditional stakeholders like healthcare providers and regulatory bodies to...
Clinical Development
Embracing AI: Emerging Trends and Key Insights from SCOPE 2025
The SCOPE US conference in early February brought together industry leaders to explore the evolving landscape of clinical research, with technology taking center stage. From AI-driven trial design to advanced data analytics and decentralized trial solutions, innovation is reshaping how...
Clinical DevelopmentMastering CRO Oversight:
Mastering CRO Oversight:
8 Steps to Guide Your Approach
Clinical DevelopmentMastering CRO Oversight:
Mastering CRO Oversight:
8 Steps to Guide Your Approach
Clinical Development
Navigating the New Era of Decentralized Clinical Trials
Decentralized Clinical Trials (DCTs) are not a novel concept but have gained prominence with advancements in digital technology and the increasing need for patient-centric approaches. The recent release of the FDA’s final guidance on DCTs in September 2024 marks a...