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Clinical Planning

Optimizing study parameters at the outset, we create operational efficiencies that ensure timely, efficient, and accurate study completion. This attention to planning avoids many common protocol difficulties, enrollment delays, and regulatory roadblocks.

Strategic development: Advisory/Steering Committees

While many companies have knowledgeable personnel in some areas of their product development, few have adequate expertise in the full spectrum required in the current drug development environment. Ideally, a blend of interdisciplinary expertise (i.e. toxicology, clinical pharmacology and pathophysiology, statitical, regulatory) is required to bridge the pre-clinical evaluation, clinical development, and marketing stages. A Steering Committee provides the sponsor with these tools.

Catalyst provides the experience in coordinating the perspectives of the critical diverse disciplines required to form a cohesive drug development strategy. This allows us to facilitate Sponsor-Steering Committee working relationships to produce plans congruent with the sponsor's objectives, ideal regulatory position and project resources. Examples of services provided by a Steering Committee include:

  • Review and assessment of pre-clinical data
  • Review viability of the proposed drug/indication (from both regulatory, Clinical and Marketplace perspectives)
  • Startegic guidance for the development program
  • Design clinical trial protocols
  • Participate in presentations to regulatory authorities
  • Oversight of clinical trial progress
  • Identify and address potential modality-specific development problems
  • Develop professional marketing tools

Project Management

At Catalyst, the collaborative relationship we develop and maintain with our clients is a vital part of our approach to providing continuity throughout our clients' projects. The individual attention each client receives from a fully dedicated Project Manager complements our approach.

With one of the lowest staff turnovers in the industry, the project management professionals assigned to your project from the start will be there to see it through to the finish. As your representative, they are wholly attuned to your needs and will efficiently and diligently manage all critical aspects of the study, with an eye on timeliness, regulatory approval, and client satisfaction.

Medical Writing

Rendering complex data analysis into clear, concise, scientifically accurate documents is as much art as science. Catalyst medical writers convey your clinical data into protocols and amendments, final study documents, publications, safety reports, and regulatory filings in strict accordance with prevailing regulations and guidelines.