Through the IVD CRO Services division, BBL offers a full suite of clinical trial management services from initial study design to final regulatory submission. As a full service BBL has successfully completed clinical validation studies in the United States, Africa, Europe, Asia and South America. BBL offers a full ’turnkey’ approach to outsourcing clinical validation studies. Our proprietary network of principal investigators allows us to rapidly identify some of the most significant and rare global patient populations and decreases the time to market of products. BBL’s access to central laboratory services, provides the value‐added testing necessary to demonstrate clinical efficacy.

Overview of IVD CRO Services

✔ Full‐service performance diagnostic and pharmaceutical trials
✔ The development of HIPAA‐compliant informed consents, collection protocols and CRFs
✔ Institutional Review Board (IRB), Independent Ethics Committee (IEC) and Ministry of Health (MOH) submissions, both

Domestic and International

✔ Site selection, initiation and monitoring, utilizing BBL’s proprietary Investigator Network
✔ On‐site sample management and logistical support
✔ Short‐ and long‐term storage of samples
✔ Access to central laboratory services, including parallel testing and data transmission
✔ Management and analysis of data collected during the study
✔ Consulting services to prepare submissions to relevant regulatory bodies, such as the US Food & Drug Administration (FDA)

Overview of Boca Bio’s Investigator Network

✔ The reach of BBL’s Investigator Network extends to 5 continents and to over 50 countries around the globe
✔ Our Principal Investigator Network (PIN) is comprised of over 250 investigators, globally
✔ Members of the PIN are partners of Boca Bio and critical enablers of BBL’s clinical trial and biological sample services
✔ BBL leverages the reach and expertise of its Global Investigator Network to enable the recruitment of hard to find patient populations
and procure rare biological materials.
✔ Boca Bio has managed IVD Clinical Trials for some of the largest IVD companies, including Roche, Abbott, Ortho‐Clinical Diagnostics, Bayer, Gen‐Probe and others
✔ BBL has the capability, though this network, to collect a wide variety of patient populations and various matrices.

Please contact us to discuss your current or near future needs at sales@bocabio.com or (954) 449‐6126.