Synergos - Services - Clinical Trial Management

Synergos Consultants in Biomedical Research

Services - Clinical Trial Management

SYNERGOS' clinical trial experience encompasses pharmaceutical products, medical devices, gene therapies, and other biotechnology products. We manage all aspects of clinical trials across a wide range of therapeutic areas.

When planning a development program for our clients, we always take a cost-effective approach. Recently a Sponsor contacted us to conduct a 200-patient cardiovascular trial. After a thorough review of the protocol and some preliminary statistical work, we found that only 30 patients were needed to generate the necessary data for the FDA. The study was redesigned with an 85% reduction in the number of patients, saving our client substantial time and resources.

Clinical Trials Management Services include:

Phase I, II, III, IV, pre-clinical, and post-marketing studies
Clinical development plans
Study, protocol, and Case Report Form design
Investigator recruitment
Pre-study site assessment
Preparation of training materials
Site initiation, training, and close-out
Patient recruitment
Patient randomization
Clinical trial monitoring
Adverse event reporting