Apex Clinical Trials, LLC (Apex) is a Trial Management Organization (TMO) conducting phase II-IV, out-patient medical, psychiatric (CNS), medical device and combined product clinical trials in geriatric, adult, and adolescent patient populations for the pharmaceutical, biotechnology, medical device and combined-product industries in the United States,  with new sites opening shortly in the European Union and several other countries.

for Sponsors & CROs
Apex offers investigator sites to sponsors and CROs in the United States at no cost. The Apex clinical trials process speeds up investigator site qualification tremendously with centralized feasibility questionnaire, budget, contract and regulatory submissions to significantly reduce time and resources expended to evaluate and qualify an investigator and the site.

Apex staff have extensive clinical trials experience in using Interactive Voice Response Systems (IVRS), and Electronic Data Capture (EDC) technology, and are very familiar with the FDA, ICH and GCP guidelines. Apex sites are also in full compliance with HIPAA privacy regulations. Apex investigators, clinical research coordinators, and support staff are trained and managed with a uniform set of Standard Operating Procedures (SOP’s), to ensure standard, dependable and clean data collection and regulatory documents processing.

Apex investigators have been one of the high enrollers in all studies to date and use a professional patient recruitment organization with their own call center.

for Investigators and Investigator Sites
Apex offers new studies to investigators with centralized CDA, feasibility, budget, contracts, regulatory submission to sponsors & CRO’s including complete patient recruitment. We also provide study coordinators and support infrastructure set up.