The Team at Boca Biolistics has been providing human biospecimens to Diagnostic and Pharmaceutical clients for over 25 years.
It has been our goal to achieve a balance of quality product, service and support. Boca Biolistics provides bio fluids and tissue to support the entire product life cycle from early stage discovery materials to panels and controls for product support and everything in between. Find out more about how Boca Biolistics can help you in whatever stage your product is in the life cycle by clicking here.
Boca Biolistics is managed by a team of professionals who are dedicated to meeting the needs of its customers and creating overall value for its partners and clients.
- Meet and exceed our clients expectations
- Provide the highest level of customer service
- Continually improve our systems
- Develop and maintain a long term partnership with our customer
Boca Biolistics is committed to protecting the privacy and security of personal health information in its possession and to complying with all state and federal requirements applicable to the handling and release of medical records and medical information.
Boca Biolistics has developed and implemented certain policies and procedures to ensure its compliance with applicable rules and regulations as set forth under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
BIOFLUID AND BIOTISSUE REPOSITORY
- Over 150,000 highly characterized samples
- Matched patient samples sets with detailed longitudinal data
- Samples collected under IRB/IEC/MOH approvals
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
- Turnkey service from dedicated professionals
- Large, multi-national Principal Investigator network
- Regulatory support, project and data management
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.
- Personalized project management of studies
- 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.
5001 NW 13th Ave, Bay H, Pompano Beach, FL 33064
Clinical Research Services:
Biobanx Core Oncology Facility: