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.

“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."

“…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."

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!

“…We have no reservations

"...We have no reservations recommending CATO to other companies requiring assistance with the monitoring of all phases of clinical trials..."

- Global Pharma Co.

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-22T15:48:10-05:00

- Global Pharma Co.

"...We have no reservations recommending CATO to other companies requiring assistance with the monitoring of all phases of clinical trials..."

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.

“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."

“…Thanks to all of you!

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project!
Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

Global U.S. Biotechnology Company

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2017-11-21T21:08:17-05:00

Global U.S. Biotechnology Company

"...Thanks to all of you!  You guys are terrific!  It's a real pleasure to work with you.  Thanks to all the efforts and professional work.  Looking forward for the next phase on this project! Please find attached the APPROVAL letter for Product.  Please share in our excitement as you have been partners in this adventure!"

Pleasure working with all of the folks at CATO

It has been a real pleasure working with all of the folks at CATO that have touched our IND over the years for all the various submissions such as Protocol Amendments, Information Amendments, Request for Meetings and SPAs, IND Safety Reports, and Annual Reports.

The quality review and attention to detail has been exceptional. The guidance you provided to format and structure was very helpful and allowed us to be more efficient in our work.

I appreciate all your hard work and commitment to our program! Hopefully we will cross paths again.

- Biotech in Cambridge, MA, USA
Head Clinical/Regulatory Operations

Cato Research - International Contract Research Organization | Research Triangle Park, Durham, North Carolina
2018-01-29T20:37:12-05:00

- Biotech in Cambridge, MA, USA
Head Clinical/Regulatory Operations

It has been a real pleasure working with all of the folks at CATO that have touched our IND over the years for all the various submissions such as Protocol Amendments, Information Amendments, Request for Meetings and SPAs, IND Safety Reports, and Annual Reports. The quality review and attention to detail has been exceptional. The guidance you provided to format and structure was very helpful and allowed us to be more efficient in our work. I appreciate all your hard work and commitment to our program! Hopefully we will cross paths again.

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.  

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