Newsletter | May 9, 2024

05.09.24 -- What To Expect From An FDA Inspection

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DIA 2024

DIA 2024 invites industry, regulators, governments, academics, innovators, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community. Hosted in San Diego, DIA 2024 will amplify different perspectives while highlighting expertise across the globe to reimagine current processes that better enhance health and well-being.

OUTSOURCING MODELS

Fortifying The 3 Cs With Strategic Approaches And Tools

In part two of this series, the authors continue the discussion by identifying specific tools and strategies that companies can use to improve communication and collaboration.

PV Solutions Optimizing End-To-End Safety In Clinical Development

Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.

Human Abuse Potential

With over 60 HAP studies successfully conducted in the last decade, Altasciences has experience in diverse areas such as for stimulants, opioids, and sedative-hypnotics.

How To Improve Site Experience Through IRT And eCOA Integration?

Experience automated patient information flow from IRT to eCOA, reducing errors and investigator burden. Kayentis Clin’form stands ready for integration, simplifying your trial processes.

REGULATORY & COMPLIANCE

What To Expect From An FDA Inspection

Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights into what to expect when the FDA comes knocking at the door of your clinical trial site.

FDA’s Updated Draft Guidance On Reporting Of Diversity Data

To ensure the safety and effectiveness of medical products for different populations, learn how the FDA is standardizing data collection and reporting for all new clinical trials and studies.

2024 MedTech Regulatory Updates: 4 Areas Of Interest

In 2024, McKinsey's projections foresee a promising year for the MedTech industry, driven by innovation but shadowed by regulatory uncertainty.

Preparing For Post-Market Clinical Follow-Up Under EU MDR

Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

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  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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