09.25.25 -- FDA Issues New Guidance For Clinical Trial Dosage Of Oncology Therapeutic Radiopharmaceuticals

Sponsors and CROs are increasingly outsourcing patient recruitment to specialized vendors to address the ongoing challenge of meeting initial recruitment targets on time.

Parenteral drug manufacturing is undergoing a rapid transformation, driven by emerging technologies and shifting market demands. There is a growing emphasis on patient-centric design and usability.

In a collaborative outsourcing model, the sponsor maintains direct contact with functional leads, eliminating communication gaps and enabling faster, better-informed decision-making.

What steps can you take to select the best CRO partner for your Phase 1 clinical trial?

Watch to discover the key benefits of outsourcing your OSD production and explore real-world examples and best practices to help you streamline your processes and enhance your operational agility.

Learn about strategies that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.

Explore how expedited review pathways can be strategically used to accelerate development while mitigating CMC risks.

Learn about an organization dedicated to providing personalized and adaptive trial solutions and managing complex oncology and hematology clinical trials.

Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.

Joshua Kresh, Emily Michiko Morris, and Mark Schultz from IPPI: The Intellectual Property (IP) Policy Institute discuss the dos and don’ts of IP and trade secrecy protections for biotech.

As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

This report outlines ten defining HEOR trends influencing global health decision-making.

Explore comprehensive pharmacovigilance (PV) solutions designed to ensure global compliance while adapting to the complex, country-specific regulatory landscapes.

These tailored assessment and support offerings in clinical quality assurance (CQA) compliance are designed to safeguard adherence to relevant regulations and good clinical practice (GCP).