About

About

About Cato Research

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. We provide integrated services to pharmaceutical, biotechnology, and medical device companies. We specialize in complex development programs requiring innovative regulatory and clinical strategies, and we have experience implementing and conducting successful clinical trials and development programs.

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, in more than 30 years of operation, 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.

As a midsize CRO, Cato Research offers a complete range of services with personalized attention and flexibility. The relationships we create with our sponsors produce positive, tangible results.

 

Cato History

Allen-Cato-Lynda-Sutton
In 1988 Dr. Allen Cato and Lynda Sutton, cofounded Cato Research.

Dr. Allen Cato and Lynda Sutton founded Cato Research in 1988 as a contract research and development organization to help pharmaceutical and biotechnology companies design and execute successful development strategies. Cato Research provides sponsors with a cost-effective alternative to building an internal structure for research and development while contributing the highest quality scientific, medical, and regulatory expertise. From the beginning, Cato Research has been recognized for our knowledge of science and technology, as well as our ability to guide creative new products through the regulatory process. Cato Research has taken a controlled-growth approach, expanding its operations selectively across North America and in other selected international countries.

In 2018, Cato Research formed a strategic partnership with healthcare investors, JLL Partners and Water Street Healthcare Partners, to continue its successful growth and expansion.

With a unique footprint that encompasses regulatory, clinical, scientific and preclinical services, Cato is large enough to undertake substantial programs, but small enough for each client project to matter.

Mission and Quality Statements

Cato Research Mission Statement

The mission of Cato Research is to be the premier, scientifically and medically based, international, healthcare research and development service company, and to build value for our clients, partners, and their stakeholders.

Cato Research Quality Policy Statement

Cato Research is committed to providing quality services and products that consistently meet or exceed sponsor and regulatory requirements and expectations.

Accolades

With timely advice for over a decade, sponsor personally acknowledges
Cato Research for their significant involvement in their success.

“…Cato was instrumental

"…Cato was instrumental in helping us with site identification, site qualification, supporting our regulatory submissions and identification of quality vendors in support of trial logistics.




They supported us regarding the IVRS system, monitoring central labs and build of lab kits. The collaboration between Cato and [OUR COMPANY] was excellent."

- Global Healthcare Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-22T15:49:15-05:00

- Global Healthcare Company

"…Cato was instrumental in helping us with site identification, site qualification, supporting our regulatory submissions and identification of quality vendors in support of trial logistics. They supported us regarding the IVRS system, monitoring central labs and build of lab kits. The collaboration between Cato and [OUR COMPANY] was excellent."

“Dear Cato team,

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline.


All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

-Specialty Pharmaceutical Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:16:33-05:00

-Specialty Pharmaceutical Company

Thank you so much for all your hard work which has resulted in our NDA being submitted one day earlier than our already extremely tight timeline. All our partners were very surprised when we set such an ambitious timeline in April when we changed from a paper CR to an eCTD, and many have said they did not think we would make it.  But with your team spirit and hard work the impossible has been made possible."

Very impressed with the quality and efficiency that Cato…

"I’m very impressed with the quality and efficiency that Cato put into the protocol. Kudos for your team. I am hoping that we will have more collaboration with you in the near future, not only for NDA, but for other technical writing projects."

- Vice President of Medical, Southeast Pharmaceutical Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2019-11-08T15:45:27-05:00

- Vice President of Medical, Southeast Pharmaceutical Company

"I’m very impressed with the quality and efficiency that Cato put into the protocol. Kudos for your team. I am hoping that we will have more collaboration with you in the near future, not only for NDA, but for other technical writing projects."

“Thank you for your continued support and valuable contribution…

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug].

On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

- Biotechnology Company Headquartered in Rockville, MD, USA

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-22T15:53:33-05:00

- Biotechnology Company Headquartered in Rockville, MD, USA

"We would like to share some good news with the Cato Team. Yesterday, we received FDA Breakthrough Therapy designation for our [ABC Drug]. On behalf of our company, we would like to thank you for your continued support and valuable contribution to the success of our regulatory submissions."

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

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
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."

Type C Meeting with FDA

Dear CATO team,

On behalf of the our team, I would like to thank you for your support at the Type C meeting with FDA as well as your great input and challenge at the prep meeting. We could secure the outcome that we wanted to achieve!

- VP Global Regulatory Affairs

European Pharma Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2019-12-06T10:51:16-05:00

- VP Global Regulatory Affairs

European Pharma Company

Dear CATO team, On behalf of the our team, I would like to thank you for your support at the Type C meeting with FDA as well as your great input and challenge at the prep meeting. We could secure the outcome that we wanted to achieve!

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

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
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.

Our CATO team has been really delivering for us.

Our CATO team has been really delivering for us. We have had a lot of Information Requests throughout the NDA review and have provided a number of submissions to CATO, very late in the day often at inopportune times, despite intensive planning from the moment of receipt. We do not wish to make a habit out of this and continue to strive to ensure there is fair and adequate time for everyone to do their job under reasonable circumstances. Our team has consistently delivered, and gone above and beyond over and over.

 

- North America Biopharmaceutical

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2019-05-28T13:12:27-04:00

- North America Biopharmaceutical

Our CATO team has been really delivering for us. We have had a lot of Information Requests throughout the NDA review and have provided a number of submissions to CATO, very late in the day often at inopportune times, despite intensive planning from the moment of receipt. We do not wish to make a habit out of this and continue to strive to ensure there is fair and adequate time for everyone to do their job under reasonable circumstances. Our team has consistently delivered, and gone above and beyond over and over.  

“…Your firm consistently supported our company

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device.


We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

- Canadian Medical Technology Co.

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-22T15:46:09-05:00

- Canadian Medical Technology Co.

"…Your firm consistently supported [OUR COMPANY] in its clinical research efforts that resulted in [OUR COMPANY] being the first and only Canadian company to ever obtain a FDA PMA approval for a therapeutic medical device. We have no reservations in considering CATO as an important partner for our future clinical endeavors and recommending CATO to other companies."

“…And a special thank you

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well.


Thank you again for all of your help.  We couldn't have done it without you!"

- Pharmaceutical Company Headquartered in Los Angeles, CA

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:12:43-05:00

- Pharmaceutical Company Headquartered in Los Angeles, CA

"…And a special thank you to you and everyone at CATO.  You have been a very very valuable partner in this journey and we could not have gotten to where we are without you.  I deeply appreciate everything that you and your team at CATO have done for us and I look forward to continuing to have a strong relationship with CATO in the future as well. Thank you again for all of your help.  We couldn't have done it without you!"
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Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina