Clinical Study Design & Management

Clinical studies are often a crucial factor in the process of bringing a new medical product to market. Conducting a clinical trial in an ethical and appropriate manner is a key factor in ensuring a successful regulatory submission.

 

Push-Med provides its clients with guidance, management tools and assistance in designing and executing their clinical trials.

 

CLINICAL PROTOCOL:
We develop protocols to support regulatory processes and market demands while focusing on product's intended claims, patient population, clinical utility, sources of error or bias, and other applicable aspects.

 

CLINICAL DOCUMENTATION:
We assist in developing the additional documentation required to initiate the clinical study (e.g., Case Report Forms, Investigator’s Brochure, Standard Operating Procedures, etc.).

 

STUDY AUDITING:
We conduct audits of clinical trials sites to validate compliance with the protocol, GCP principles, and other regulatory requirements.

 

STUDY ANALYSIS & REPORTS:
We use well-recognized statistical procedures to analyze and interpret study results and to prepare study interim and final reports.