Services: Integrated Drug Development

As part of the overall goal of Cato Research to provide integrated, full-service drug development support to clients, the mission of Integrated Drug Development scientists is to offer multidisciplinary assistance in all aspects of product development from early discovery to postmarketing.

Cato Research distinguishes itself from other contract research organizations by employing a high percentage of graduate-level scientists. Worldwide, Cato Research has more than 80 scientists at the M.D., Ph.D., or M.S. level-more than 25% of the company's total workforce. In addition to their scientific background, all Integrated Drug Development scientists receive additional education in drug development, and most are certified as regulatory affairs professionals or clinical research professionals or both. Thus, in addition to having in-depth expertise in specific therapeutic areas, Cato Research scientists have a broad knowledge of the full range of global drug development disciplines (clinical, nonclinical, regulatory, chemistry and manufacturing, statistics, etc.).

Integrated Drug Development scientists provide assistance and project leadership to strategic discussions regarding the development of drugs, biologics, and medical devices for all phases of development. Their cross-disciplinary awareness and input ensures an integrated approach to drug development. Scientists prepare and review clinical and regulatory documents and provide project management for global clinical trials and development programs. They specialize in evaluating potential and innovative technologies, devising creative and novel approaches to bring products to market.

Scientists serve as a core element of team structure that encompasses project leadership, project management, and facilitation of interactions with other Cato Research employees. As program directors or project managers, they oversee and provide direction for teams, timelines, budgets, and deliverables, and they serve as the point of contact for the sponsor.

CATO's Integrated Drug Development scientists pride themselves in the following:

  • Having scientific knowledge of drugs, biologics, and medical devices
  • Having an understanding of a range of diseases and therapeutic target mechanisms
  • Understanding how to optimize the interrelationship between the various drug development disciplines
  • Being cognizant of up-to-date developments in medicine and human health
  • Providing critical, analytical, and creative thinking
  • Having excellent written and verbal communication skills
  • Having exceptional project management capabilities and project leadership skills
  • Working effectively both within in a team structure and independently
  • Providing effective guidance and advice to teams and sponsors

Overview of Typical Tasks and Deliverables:

  • Therapeutic Development Strategies
    • Integrated development plans (for drugs, biologics, and medical devices)
    • Clinical and regulatory strategies
    • Pharmaceutical development support (chemistry, manufacturing, and controls)
    • Nonclinical pharmacology and toxicology planning and interpretation
  • Clinical Research
    • Clinical trial management
    • Protocol development
    • Study-related materials; preparation and review
    • Final data review and preparation of clinical study reports
  • Data Management
    • All elements of data flow process (e.g., case report form development, validation checks, data listing review, statistics)
  • Regulatory Documents
    • Regulatory agency premeeting packages (e.g., pre-IND, pre-CTA, pre-NDA packages)
    • Regulatory agency meeting preparation, rehearsal, and participation
    • Preparation of INDs, CTAs, ITAs, and IDEs (including electronic submissions)
    • Preparation of NDAs, BLAs, NDSs, and CTDs (including electronic submissions)
    • Investigator's Brochures
    • Annual reports
  • Corporate Services
    • Standard operating procedures and template development
    • Training and education
    • Business development