Boca Biolistics provides bio fluids and tissue for nearly all bio markers currently required for assisting our clients in any stage of the product life cycle. We offer specimens from our proprietary specimen bank for the Discovery and Development phases. We offer full clinical trial support through CRS our IVD CRO Services. Lastly, we provide bulk material for assay controls and custom panels for product verification and client site support.
Biofluid and Biotissue Repository
BBL offers an extensive inventory of rare and sought-after human biological materials, collected under respective IRB, IEC or MOH from populations around the globe. From its repository, BBL offers specimens of blood, urine and tissue, representing infectious diseases and other diseases that are significant to oncology, cardiology, endocrinology, rheumatology, and genetic disorders. Biological samples are accompanied by detailed medical information related to patients and other bioinformatics such as genotypic data. From Normal Human Sera to Cancer tissue and everything in between, BBL can provide you with the necessary biomarker material to accelerate whatever phase your product is in.
BBL maintains a comprehensive inventory of prospectively collected biological materials from around the globe. BBL also stores biological materials on a short- and long-term basis for customers. BBL’s Bio-Repository is highly secure, temperature-control alarmed and protected 24/7. BBL’s cold storage facilities are capable of storing biological materials at -80ºC, -30ºC and 2-8ºC on a short-, mid- and long-term basis. BBL is fully compliant with all current Good Laboratory Practices (cGLP).
To enhance its cold storage capabilities, BBL has developed a proprietary barcode-enabled accessioning system and specimen database, which enables the real-time control of inventory and data storage. To facilitate the transport of materials to and from storage, BBL specializes in the packaging and shipping of biohazards on an international basis, conforming to International Air Transport Association (IATA) standards
IVD CRO Services
Through the IVD CRO Services division, BBL offers a full suite of clinical trial management services from initial study design to final regulatory submissions. 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. BBL’s proprietary network of principal investigators, enables our IVD CRO services to rapidly identify the most significant and rare global patient populations and decrease the time to market of products. BBL’s full service central laboratory services provides the value-added testing necessary to demonstrate clinical efficacy.
BBL offers a complete suite of clinical trial management services, including:
- 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, globally
- Site selection, initiation and monitoring, utilizing our global PI Network.
- On-site sample management and logistical support
- Short- and long-term storage of samples in the Bio-Repository
- Central laboratory services, including parallel testing
- 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)
For more information on BBL’s Products and Services, please click here.
If you are planning a clinical trial soon, consider allowing BBL to manage all or part of your clinical trial as a time and cost-saving alternative to managing the trial in-house. Please contact us directly to see how BBL can improve your time to market.