Cato Research

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Cato Research
Type private
Industry Pharmaceuticals
Founded 1988
Headquarters Westpark Corporate Center 4364 South Alston Avenue Durham, North Carolina USA 27713-2220
Number of employees 201-500

Cato Research (CATO) is an international regulatory and clinical contract research organization (CRO) that has been delivering successful outcomes for its clients for more than 27 years. 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 pre-clinical through IND (or equivalent), clinical development, and marketing approval to Phase 4 post-marketing 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 27 years of operation, CATO has been involved in a wide variety of projects with a dominant focus in oncology, neurology/CNS, and orphan drug indications. This experience includes leadership of, and involvement in some of the most challenging and innovative products. [1]


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.

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.


  • Regulatory assessments and strategy development
  • Interactions with regulators, including authoring and managing submissions
  • Preclinical/toxicology development programs; study management and monitoring
  • Pharmacokinetic study design and management
  • Clinical strategy
  • Phase 1 through Phase 4 clinical study design, implementation, trial management, and monitoring services
  • Data management
  • Statistical analyses and integrated statistical/clinical study reports
  • Medical affairs
  • Medical writing
  • Program and project management
  • Safety and pharmacovigilance
  • Chemistry, manufacturing, and control programs
  • Quality Clinical Trial Oversight
  • Quality assurance, including audit and compliance activities for GCP, GLP and GMP
  • Due diligence activities for emerging technologies

Medical Affairs & Pharmacovigilance

The goal of Medical Affairs at CATO is to provide high-quality medical oversight and advice to all phases of the drug development process. CATO physicians have extensive experience with: * Ensuring patient safety, providing superior clinical expertise, and meeting regulatory requirements.

  • Direct patient care, academic medicine, teaching, and all phases of drug development.
  • Medical writing, grant writing, peer review publications, editorial process, journal editing, and authorship of books, monographs, and other documents.
  • Writing and editing of INDs; NDAs; BLAs; orphan status applications; fast track applications; pre-IND packages; EOP1, EOP2, and EOP3 packages; and grant applications to NIH, NCI, American Heart Association, and the Howard Hughes Medical Institute.
  • Professional presentations at meetings of medical congresses, steering committees, investigators, data and safety monitoring boards, and FDA advisory committees.
  • Clinical practice that includes emergency medicine, internal medicine, preventive medicine, oncology, otolaryngology, pathology, pediatrics, cardiology, critical care, clinical pharmacology, genetics, infectious diseases, laboratory medicine, occupational and legal medicine, neonatology, pulmonary diseases, and both animal and human toxicology.

CATO's Pharmacovigilance division within Medical Affairs maintains global medical oversight operations, including development and implementation of customized safety processes that routinely undergo quality improvement.

  • Pharmacovigilance provides all necessary support for safety database construction and maintenance, adverse event reporting, and other standard safety functions, including post-marketing safety and special interest in the design and implementation of electronic CRF and regulatory documents.
  • Selected clinical trial experience includes: immune globulin and monoclonal antibody therapy; pulmonary hypertension; asthma; chronic obstructive pulmonary disease; respiratory distress syndrome; adult respiratory distress syndrome; congestive heart failure; acute myocardial infarction; stroke (neuroprotection); gene transfer (heart and skeletal muscle); inflammatory bowel disease; osteoarthritis; diabetic neuropathy; cancer (colon, lung, melanoma, stomach, pancreas, leukemia, lymphoma, stem cell therapy); Alzheimer’s disease; schizophrenia; epilepsy; and vaccines (cancer, DTaP, N. meningitidis, HiB, C. jejuni, anthrax, and plague). [3]



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