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.
CONTACT US
Push-Med LLC
1914 J.N. Pease Place
Charlotte, NC 28262
USA
Tel: 704.899.0092
Fax: 704.899.0098