Read more about the article FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria
FDA Issues New Draft Guidances On Cancer Clinical Trial Eligibility Criteria

FDA’s New Draft Guidances on Cancer Clinical Trials Eligibility Criteria

The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.

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Read more about the article Exploring the Evolving Landscape of Ophthalmology Clinical Development
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Exploring the Evolving Landscape of Ophthalmology Clinical Development

Few fields in clinical research are as dynamic and promising as ophthalmology. With the global population ageing and eye diseases becoming more prevalent, there is a growing demand for innovative treatments and therapies. This blog explores the emerging trends and updates that are shaping the ophthalmology clinical development landscape.

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Read more about the article Empowering Biotech and Pharma: The Vital Role of Full-Service CROs
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Empowering Biotech and Pharma: The Vital Role of Full-Service CROs

In the dynamic landscape of biotech and pharma, the role of a full-service CRO is more crucial than ever. CROs serve as invaluable partners for biotech and pharma, offering comprehensive…

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Read more about the article Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies
Ensuring Data Integrity: FDA's Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.

Continue ReadingEnsuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies
Read more about the article Understanding the Basics of Clinical Trials: Participation, Purpose, and Process
Understanding the Basics of Clinical Trials: Participation, Purpose, and Process.

Understanding the Basics of Clinical Trials: Participation, Purpose, and Process

Clinical trials are essential to advancing medical research and improving healthcare. Understanding the basics of clinical trials helps demystify the process and highlights their importance. This guide covers the key…

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Read more about the article FDA and Clinical Trials: Ensuring Safety and Efficacy
FDA and Clinical Trials - Ensuring Safety and Efficacy - Lambda CRO

FDA and Clinical Trials: Ensuring Safety and Efficacy

FDA and Clinical Trials: Clinical trials stand as the cornerstone of pharmaceutical and biotech advancements, enabling new treatments and therapies to reach patients worldwide. At the helm of this transformative…

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