Clinical Samples

Through the Clinical Sample Collection (CSC) division at Boca Biolistics, Boca Bio is capable of providing clinical trial management services from initial study design to final regulatory submissions. Boca Bio can accommodate prospective collections of samples from the USA, Africa, Latin America, Europe and Asia.

CSC offers a complete suite of clinical trial management services, including:

• The design of HIPAA-compliant informed consents, sample collection protocols and CRFs
• Independent Review Board (IRB), Independent Ethics Committee (IEC) and Ministry of Health (MOH) submissions.
• Site selection, initiation, monitoring and sample shipment logistics
• Short- and long-term storage of samples
• Testing service through partnership with local CLIA laboratory experienced in IVD trial testing
• Consulting services to prepare submissions to relevant regulatory bodies, such as the US Food & Drug Administration (FDA)

If you are currently in need of samples or planning a clinical trial in the future, consider Boca Biolistics as a part of your team to support all or part of your clinical trial needs. Please contact us directly to see how we can improve your time to market.

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