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The rising impact of biomarkers in early clinical development

Drug Target Review

The context of use (COU) of biomarker assays must be firmly established, clearly and comprehensively citing how they should be used, and the regulated product development and review-related purpose of that use. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. One major concern is its tendency to hallucinate, confidently producing factually incorrect information.

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Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

PPD

Prioritizing the idiopathic pulmonary fibrosis patient experience in clinical trials Understanding the patient experience is paramount to the success of idiopathic pulmonary fibrosis clinical development. Even attending their regular clinic visits can be exhausting and stressful. Ready to connect?

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Harnessing AI and Real-World Data: The Future of Clinical Development

PPD

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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9 Ways Worldwide Optimizes Clinical Development for Your Biotech Growth Journey

Conversations in Drug Development Trends

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You can expect transparency.

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Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Conversations in Drug Development Trends

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. As we look towards future developments in oncology and beyond, the importance of strategic regulatory planning and execution cannot be overstated.

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The Evolution of Adaptive Protocols: Early Clinical Development

PPD

The possibility for change needs to be ethically sound and clear to all involved, including investigators, site staff and cross-functional team members, like clinical monitors, statisticians, data managers and vendors. Each step of the process is conducted with an eye toward supporting later-phase programs and regulatory submissions.