Blog

Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection

June 27, 2022

The International Conference on Harmonization/Good Clinical Practice E6 (ICH GCP) lays out clear expectations for both the sponsor and investigators...

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Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

April 14, 2022

As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to...

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The Potential of Biosimilars – for Drug Makers and Patients

March 24, 2022

The production of biosimilar drugs remains at a rapid pace, and represents not only an advantage for patients, but a...

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The Multifaceted Role of the Nonclinical Expert at the Center of Drug Development Teams

March 14, 2022

Product development teams getting started on preclinical exploration of a potential treatment need a certain set of specialists on board....

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The Black Box of Anti-COVID-19 Monoclonal Antibodies: An Overview, Definitions, and Terminology

March 14, 2022

We learned on 25 January 2022 that the U.S. Federal Drug Administration (FDA) halted use of most monoclonal antibodies for...

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Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways

March 10, 2022

In recent years, we have observed a significant increase in use of expedited programs offered by the U.S. Federal Drug...

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The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

January 20, 2022

Chimeric Antigen Receptor T cell (CART) has revolutionized the treatment of hematological malignancies, including B-cell acute lymphoblastic leukemia, B-cell lymphomas,...

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Great News from EMA in December: Three New Treatments for COVID-19

January 12, 2022

December 2021 brought great news for European COVID-19 patients, their health care providers, and the whole population suffering from medical...

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Cervical Health Awareness Month – Cervical Cancer: Prevention, Detection, Development

January 3, 2022

Cervical Health Awareness Month is a good time to review the state of cervical cancer, what you can do personally,...

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EU Clinical Trial Regulation: What, When, Who, Why, How?

June 15, 2021

The long-anticipated European Union (EU) Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR), intended to improve and coordinate the submission and review...

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