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Boca Biolistics, LLC.

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pompano beach, Florida, US

About Boca Biolistics, LLC.

Boca Biolistics (BBL) has been a trusted partner in the development of in vitro diagnostic (IVD) and biopharmaceutical products. BBL provides products and services that support research and development activities and accelerates the time to market of products. We offer clinical trial management services,... Show more »

Boca Biolistics (BBL) has been a trusted partner in the development of in vitro diagnostic (IVD) and biopharmaceutical products. BBL provides products and services that support research and development activities and accelerates the time to market of products. We offer clinical trial management services, biological materials, central laboratory testing and other solutions that enable product development and research in infectious diseases, oncology, rheumatology, endocrinology, cardiology and genetic disorders. We now offer complete CDx services from bio specimens, prospective collections and our molecular oncology reference laboratory.

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Certifications & Qualifications

ISO 13485

Diversity Certificates

Small business

Our Services (39)


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Fixed Human Tissue

Price on request
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In vitro Diagnostic/Companion Diagnostic Testing

In Vitro Diagnostic Testing
Price on request

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’... Show more »

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.

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Biospecimens

Price on request

Match patient sets and longitudinal sets are also available upon request. With our Central Laboratory Service, we can also provide any testing needed on any of our over 50,000 inventoried specimens or prospectively collected samples.

  • Hepatitis/HIV
  • Autoimmune
  • Cardiac Disease
  • Thyroid/Endocrinology
  • General... Show more »

Match patient sets and longitudinal sets are also available upon request. With our Central Laboratory Service, we can also provide any testing needed on any of our over 50,000 inventoried specimens or prospectively collected samples.

  • Hepatitis/HIV
  • Autoimmune
  • Cardiac Disease
  • Thyroid/Endocrinology
  • General Chemistry
  • Normal/Healthy Donors
  • Therapeutic Drug Monitoring
  • Cancer
  • Drugs of Abuse
  • ToRCH IgG & IgM
  • Diabetes
  • High Risk Population

✔ Samples are obtained by clinicians who are part of the Boca Bio’s Global Investigator Network, received and processed by BBL sample processing technicians and then archived in our Bio‐Repository.

✔ Sera and urine sample sizes ranging from 0.5 to 1,000mL. FFPE tissue ranging from individual slides to complete blocks. ‘Snap Frozen’ and fresh tissue ranging from several to hundreds of grams.

✔ Samples are stored at BBL’s Bio‐Repository facility in Coconut Creek at temperatures as cold as ‐80º C to ensure product integrity.

✔ Specimens are accompanied by a case report form (CRF) or clinical data that can include a donor’s demographic and case history (testing, therapy and family) information.

✔ Every sample is procured under IRB, IEC and/or MOH approved collection protocols.

✔ Each biological sample is characterized by various laboratory tests to obtain qualitative and quantitative data related to biochemistry, hematology, infectious disease serology, antigen/antibody detection and viral RNA and DNA presence.

Boca Bio can accommodate almost any request for specimen needs for your Discovery or Development phases of your product life cycle. Please contact us to discuss your current or near future needs.

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Histology and Pathology Services

Price on request

Boca Bio offers Histology Services to complement our tissue products. Using state-of-the art technology, Boca Bio can process tissue samples that will meet your needs and accelerate your research. Boca Bio’s staff has extensive expertise and is available to discuss your custom needs. These services include general and complex... Show more »

Boca Bio offers Histology Services to complement our tissue products. Using state-of-the art technology, Boca Bio can process tissue samples that will meet your needs and accelerate your research. Boca Bio’s staff has extensive expertise and is available to discuss your custom needs. These services include general and complex histological procedures.

Pathology Service for Researchers

  • Pathology lab services
  • Evaluation of tumor tissues
  • Consultation services

Sectioning of Human Tissue Samples

  • Paraffin Tissue
  • Frozen Tissue

Custom Histology

  • H&E stain
  • Other stains and services
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Clinical Trial Management

Price on request
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Clinical and Anatomic Pathology

Price on request

Clinical and Anatomic Pathology Services

Clinical and Anatomic Pathology Services

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Clinical Laboratory Services

Price on request

Clinical Laboratory Services

Clinical Laboratory Services

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Clinical Research

Price on request

Clinical Research Services

Clinical Research Services

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Medical Devices & Diagnostics

Price on request

Medical Devices & Diagnostics Services

Medical Devices & Diagnostics Services

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Cells and Tissues

Price on request

Cells and Tissues Services

Cells and Tissues Services

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Biology

Price on request

Biology Services

Biology Services

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Clinical Trials, Consulting, and Management

Price on request

Clinical Trials, Consulting, and Management Services

Clinical Trials, Consulting, and Management Services

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Human Biospecimen Collection

Price on request
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Human Biospecimens

Price on request

Human Biospecimens Services

Human Biospecimens Services

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Human Tissue

Price on request

Human Tissue Services

Human Tissue Services

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Human Biofluids

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Clinical Endocrinology Tests

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Clinical Immunology Tests

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Clinical Trial Documentation Support

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Clinical Molecular Diagnostics

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Assay Development Consulting

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Clinical Trial Site Selection

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Patient Recruitment

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Companion Diagnostic Development

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In vitro Diagnostic Development

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Biospecimen Management and Storage

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Human Tissue Procurement

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Human Biobanking

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Clinical Sample Management

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Human Cerebrospinal Fluid (CSF) Samples

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Human Urine Samples

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Human Immunodeficiency Virus (HIV)-Infected Biofluids

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Type 1 Diabetes Human Biofluids

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Type 2 Diabetes Human Biofluids

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Type 1 Diabetes Human Whole Blood

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Hepatitis B Virus (HBV)-infected Human Whole Blood

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Hepatitis C Virus (HCV)-infected Human Whole Blood

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Clinical Ancillary and Sample Services

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Human Whole Blood & PBMCs

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BBL Comparative Testing Info Package.pdf

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Boca Biolistics Reference Laboratory_Company Overview Bifold.pdf

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Boca Biolistics_Company Overview Flyer.pdf

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Boca Biolistics_IVD Flyer.pdf

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