A History of Impact in Drug Development
50+ Successful
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Since 1988
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Cato Research, Your Reliable Partner

Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients since 1988. Through highly qualified and experienced personnel located in offices across North America, Europe, Israel, and South Africa, supported by strategic alliances with selected regional CROs, CATO offers tried-and-trusted international coverage.

CATO has the advantage of integrated regulatory, clinical, and scientific expertise. Our highly talented and experienced international team offers services from preclinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 postmarketing research. Our track record includes successes across many different health products, including drugs, biologics, vaccines, cell therapies (including stem cells), nutriceuticals, medical foods, devices, and diagnostics. In terms of diseases and indications, CATO has been involved in a wide variety of projects with a dominant focus in oncology, neurology/CNS, and rare and orphan drug indications. This experience includes leadership of, and involvement in some of the most challenging and innovative products.

Therapeutic Expertise

What our Sponsors say about us...

Congratulations Team! Another Approval!

I would like to thank the Cato Research team for their contributions to this successful application including the advice, guidance and participation in the Type A meeting we had with the FDA last year after the CRL was issued.

I have shared the approval letter with the Executives.

- A Canadian Innovative Drug Company

2019-07-26T11:07:21-04:00

- A Canadian Innovative Drug Company

I would like to thank the Cato Research team for their contributions to this successful application including the advice, guidance and participation in the Type A meeting we had with the FDA last year after the CRL was issued. I have shared the approval letter with the Executives.

No Hesitation in Recommending CATO as a CRO that can Add Value to Any Project!

"We would like to thank CATO for the work achieved on the Phase 111 international study they managed on our behalf in the United States, Canada and Israel.

Their expertise and their valuable input in regulatory affairs allowed us to meet the timelines in these three countries.

As for monitoring, CATO's team did a great job in following up closely with the sites to get answers to multiple requests but also in being responsive to our demands.

We want to stress that the partnership spirit and the high degree of professionalism they demonstrated during this project was highly appreciated.

This is the reason why we are looking forward to continuing our collaboration for future studies.

Consequently we have no hesitation in recommending CATO as a CRO that can add value to any project."

- European International CRO

2019-08-20T14:05:41-04:00

- European International CRO

"We would like to thank CATO for the work achieved on the Phase 111 international study they managed on our behalf in the United States, Canada and Israel. Their expertise and their valuable input in regulatory affairs allowed us to meet the timelines in these three countries. As for monitoring, CATO's team did a great job in following up closely with the sites to get answers to multiple requests but also in being responsive to our demands. We want to stress that the partnership spirit and the high degree of professionalism they demonstrated during this project was highly appreciated. This is the reason why we are looking forward to continuing our collaboration for future studies. Consequently we have no hesitation in recommending CATO as a CRO that can add value to any project."

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Cato Research Blog

  • New FDA Guidances for November and December 2019...
    by Cato Research on January 6, 2020 at 9:36 pm

    By Alice Li, MD, MSc, RAC(CAN), Regulatory Scientist, Cato Research Special Interest Guidances/Information Date Posted Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, […]

  • What’s New Health Canada? November 2019 Updates
    by Cato Research on December 20, 2019 at 2:41 pm

    By Alejandra Gomez Perez, M.Sc., Regulatory Affairs Associate What’s New in: Therapeutic Products Directorate: Biologics and Genetic Therapies Directorate: Medical Devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html Natural and […]

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