Newsletter | February 13, 2025

02.13.25 -- Tech Vendors Are Today's Don Quixotes

OUTSOURCING MODELS

Tech Vendors Are Today's Don Quixotes

Don Quixote is known for tilting at windmills, believing them to be enemies. Today, it seems, emerging tech solution developers are embodying the spirit of the quixotic knight centuries later.

Analytical Method Development In A High Potent Facility

Leveraging a CDMO to oversee all aspects of analytical method development is crucial for achieving speed in clinical trials, regulatory approval, and commercial launch.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Reducing Risks By Outsourcing OSD Manufacturing And Packaging

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.

Oncology Clinical Development

Our extensive oncology expertise coupled with an end-to-end approach helps accelerate your clinical programs, giving you the confidence to bring breakthrough treatments to patients.

REGULATORY & COMPLIANCE

AI In Action: Transforming Clinical Trials

Tala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance.

2025 Safety And Regulatory Compliance Trends And Predictions

Explore the rapidly evolving regulatory landscape that pharmaceutical and biotech industries face as they integrate AI and advanced technologies into safety, compliance, and lifecycle management.

Demystifying AI: Fundamentals And Applications In Drug Development

Explore the history of AI, gain clarity on key concepts, address common questions, and discover its transformative role in drug development, with insights into its current and future impact on the industry.

The Future Of Clinical Trials: 2025 Outlook

Looking ahead to 2025, clinical trials will evolve with new technologies, regulatory shifts, and emerging therapies. Explore key trends shaping the future of the industry.

Oncolytic Virus Therapy: Insights Into Industry Trends

Answering questions about the potential of oncolytic virus therapies, how they integrate with combination therapies, the regulatory landscape, and how it varies globally.

A Year Of Reflection And Preparation

The Trial Master File (TMF) landscape in 2025 will require companies to stay attuned to the evolving ICH E6(R3) guidelines and the full implementation of the CTIS.

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  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
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