Category Archive: Clinical Trials

Jul 20 2020

Are you ready for the new European clinical trial regulation?

29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is …

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Apr 29 2020

Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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Apr 24 2019

New FDA Guidance on Natural History Studies for Rare Diseases

In a recent Ask Cato blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in Drug Development.1 The guidance covers a range of topics, including the use of surrogate biomarkers, nonclinical flexibility, and natural history studies, to assist sponsors in conducting more efficient drug development programs for rare …

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Mar 12 2019

Lets talk about Patient Engagement

patient engagement , clinical trials

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and …

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Feb 19 2019

Pharmacogenetics- Tailoring your product to fit the genes

Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician   John received anti-malarial therapy and developed severe hemolytic anemia.  He was diagnosed as having G6PD deficiency. Sally was started on warfarin and there was a problem in achieving the desired therapeutic response.  She was diagnosed as having …

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Feb 08 2019

Big Data, RWE, and AI Made Simple

By Hadas Jacoby Adani, Marketing Manager, Israel, Cato Research Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands …

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Dec 04 2018

Civil Money Penalties Relating to the Data Bank

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd Civil Money Penalties Relating to the Data Bank Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to …

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Aug 09 2018

Medical Devices: Clinical Trials in South Africa – Part 1

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research   Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being …

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Jan 09 2017

New FDA Guidances for December 2016

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities …

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Jan 04 2017

Transparency Initiatives at Health Canada

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy for Cato Research Canada. As part of the Regulatory Transparency and Openness Framework (, Health Canada has committed to provide greater transparency and openness to further strengthen trust in their regulatory decisions. The Framework will: Help Canadians to better understand how and why decisions are …

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