The Cato Way

How can Cato Research help your company succeed in a competitive marketplace? First, we listen carefully to your expectations because we know the essential ingredient of a successfully integrated strategy for your products is communication. Then, our creative and experienced teams of experts carefully piece together a plan with rigorous timelines while focusing on the medical, scientific, regulatory, and statistical components of the plan. This process forges a partnership between Cato Research and the sponsor that delivers excellence in an environment that requires maximum return on investment. Above all, we focus on providing quality work you can rely on in submissions, clinical trials, and development plans.

Communication. Creativity. Partnership. Quality. Scientific Excellence. That has been the Cato Research way since 1988.

Cato Research takes pride in its ability to develop creative strategies for product development and regulatory approval. But our success and yours begins with the first step: listening. Once we understand your needs and wants, we begin to craft a direction and approach that are best suited to satisfy your objectives. We complement this approach with one or more of the specialized services we offer.

Added Value

What are the benefits of working with Cato Research? The powerful relationships that we create with sponsors can produce positive tangible results.

Examples

Here are some examples of the outcomes of our involvement in meetings with regulatory agencies:

Cato Research compiled a data package that demonstrated the results of clinical data collected under an Investigator's IND and submitted it for regulatory agency review. During a meeting with a regulatory agency, agreement was reached that a Phase 3 program for a sponsor's product-candidate could commence immediately. Benefit to Sponsor: The sponsor estimated that this effort resulted in a reduction in development costs of $1.5 million.		A development program was placed on clinical hold prior to Cato Research's involvement, based on unexpected and unexplained adverse events. Cato Research prepared a concise report summarizing extensive data and presented the results of the summary to the regulatory agency, which resulted in release of the program from clinical hold. Benefit to Sponsor: The reviewer informed the sponsor that the summary report was responsible for reducing the review time by as much as one year.

We have established a reputation for achieving reductions in time
and development costs.

Cato Research prepared several major sections of a marketing application for a product-candidate on behalf of a major European-based company. Cato Research constructed the marketing application database from 12 individual studies and recommended that the sponsor broaden the indication that was originally proposed. Cato Research prepared and presented a regulatory agency meeting package that justified the need to broaden the indication.

Benefit to Sponsor: The agency agreed that the sponsor could proceed with the strategy for the marketing application. Within a very aggressive timeline, Cato Research prepared and submitted the marketing application, and the application was ultimately approved.