With the emergence and integration of advanced drug, device and biotech research methodologies, start-ups to multi-national biomedical companies have accelerated their pace of in-human trials. They now rely upon CROs & SMOs as strategic, value-added outsource entities for study operations. Want more?Click here
CSI BOCA RATON LLC (SMO) provides assistance which includes the following
Provide a national network of physicians experienced in conducting clinical trials to the pharmaceutical companies. These include but not limited to a specific area of expertise: such neurology, gastroenterology, psychiatry, endocrinology or cardiology
Observe on a regular base that the physician adheres to Good Clinical Practices and the study protocol
Assist the physician with hiring and/or training of proper research employees.
Support and educate staff in regards with study drug accountability and proper storage.
Coordinating the completion of the required regulatory documents for their sites. Check the filing and maintenance of the required regulatory documents
Negotiating the budget for their sites.
Handling the financial aspects of the clinical trial for their sites, invoicing the sponsor, and providing payment to the sites.
Providing tools for their sites to meet enrollment commitments.
Providing their sites with a set of standard operating procedures (SOPs).
Developing study-specific source documents for their sites.
Verifying the documentation of the informed consent process for each study subject.
Ensuring that non-serious and serious adverse experiences are properly documented and reported.
Reviewing the case report form against the subject's medical record for completeness and accuracy.
Assist the sites with setting up and qualifying blood draw stations, how to process specimens for same-day central lab shipping, and have dedicated space for detained, patient observation.
