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.
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.
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.
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
“…Thanks to all of you!
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
Very impressed with the quality and efficiency that Cato…
- Vice President of Medical, Southeast Pharmaceutical Company
“…Your firm consistently supported our company
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.
No Hesitation in Recommending CATO as a CRO that can Add Value to Any Project!
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
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
“Dear Cato team,
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
Type C Meeting with FDA
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
“Thank you for your continued support and valuable contribution…
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
“…And a special thank you
Thank you again for all of your help. We couldn't have done it without you!"
- Pharmaceutical Company Headquartered in Los Angeles, CA