Standard Operating Procedures

Clinical Research Trials of Florida utilizes Standard Operating Policies and Procedures for all aspects of its operations. Staff members are required to be trained and tested on all responsibilities and procedures according to their respective functions and job descriptions. Additional sponsor training is completed upon request. A complete set of implemented SOP's can be made available upon request

GCP/ICH and other Staff Standardized Training

All investigators and support staff of Clinical Research Trials of Florida are required to complete GCP/ICH training biennial. Support Staff also are required to complete OSHA, IATA, BLS and ACLS as needed. Licenses, Trainings, and Certificates are included with signed and dated CV's upon request.

Drug / IP Storage

Clinical Research Trials of Florida is compliant with ICH/GCP practices in our drug and investigational product storage. All products are secured in a double-locked, temperature controlled, limited access room. Only those staff members allocated to dispense IP have access to our drug storage area. We have Ambient, Refrigerated and Frozen; temperature monitored storage areas.

CRF / eCRF Source Management

Clinical Research Trials of Florida is compliant with ICH/GCP practices in our document storage. All source documents are located within a locked, limited access storage room. All records are documented on Paper. We have extensive experience in paper case report forms and most industry utilized eCRF systems. (i.e. Inform, Medidata / Rave / Data Labs / MERGE and other sponsor specific systems.)

In-House Advertising & Recruitment

Clinical Research Trials of Florida has an in-house advertising and recruitment department with 2 F/T recruiters. We have extensive experience in media creation and placement in all media outlets as well as inbound and outbound call campaigns. A tactical marketing plan is created at the time of the study feasibility using our internal database, partnered physician/clinic database (both for prevalence and ability to recruit), media placement (newspaper, radio, TV, etc.) depending on the indication, prior experience, allowed budget for recruitment, etc.

Archiving

Once a study is completed and closed out by the Sponsor, Clinical Research Trials of Florida follows company SOP’s to archive study documents at our on-site storage locations. These locations are fire and water proof.

Computer Operating Systems and Capacity

Clinical Research Trials of Florida operates their computer systems on Windows 7. Clinical Research Trials of Florida does not have electronic medical records, all source documents and patient information is on paper format.

Insurance / Indemnification

Clinical Research Trials of Florida carries liability insurance with appropriate individual and aggregate limits.