Vaccine Studies
Learn more about our active vaccine clinical trials. All relevant information for individual trials can be found on each vaccine study listed here. All trials are conducted by our clinical research team including specialists in infectious disease and internal medicine.
Trusted Vaccine Trial Partner
Founded in 1998, we are a multi-specialty clinical research organization specializing in Phase I-IV industry-sponsored trials. We excel in rapid recruitment, enrollment, and randomization of both healthy and disease-specific patient populations across diverse therapeutic areas, with a strong focus on early-phase development. Our experienced medical team ensures high-quality data, earning recognition from sponsors for top- tier enrollment and performance. In response to industry demand, we successfully pivoted to COVID-19 research, enrolling symptomatic patients in phase I-III studies and earning selection as a sentinel site for an FDA-submitted antibody trial. Our adaptability, expertise, and commitment to excellence make us a trusted partner in clinical research.
Extensive vaccine experience
- Established in 1998
- 4 FDA Audits/no 483
- 12 Year Average Coordinator Experience
- Vaccine Specific Cold Chain
- Phase I Unit
- 13,000 sf Research Clinic
- Proven track record of successful Phase I-IV studies
- Rapid study start-up (7-28 days from contract to first patient enrolled)
- Large, diverse patient database with on-site recruitment department for patient recruitment & retention management
- Fully equipped with on-site pharmacy, refrigerated storage, and PBMC laboratory
Equipment
Our facility upholds the highest standards in equipment reliability, ensuring precision, compliance, and patient safety in every study.
ULT Freezers & Temp. Monitoring Systems
PBMC Processing Capabilities
Immediate Sample Processing Capabilities
State-of-the-Art ULT Freezers & Advanced Temperature Monitoring Systems
- Designed for secure and stable storage of IP, biologics, and temperature-sensitive materials.
- Maintains stable storage at -80°C (-112°F), meeting stringent regulatory requirements.
- Redundant equipment & backup generator ensure continuous operation with uninterrupted cooling, minimizing risk during power outages
- Validated & IQ/OQ compliant. All Freezers undergo Installation Qualification and Operational Qualification to meet FDA, ICH-GCP, and sponsor-specific protocols
- High-capacity storage accommodates large-scale trials with ample space for long-term sample integrity
- 24/7 Digital monitoring & real-time alerts integrated with cloud-based monitoring for instant notifications and corrective action capabilities
- Automated data logging & audit trails ensures full traceability and compliance with CFR 21 Part 11 and ICH-GCP guidelines
- Deviation Prevention & Corrective Actions- Preemptive measures in place to avoid temperature excursions, safeguarding sample viability.
PBMC’s & Processing
Cutting-Edge Cellular Processing for Precision Research
Our facility is equipped with expert-driven technology to ensure high-yield, high-viability PBMC isolation for immunology, oncology, infectious disease, and vaccine research.
Trusted by Leading sponsors, our validated methodologies align with the stringent standards of major pharmaceutical and biotech companies.
- Ficoll-Paque density gradient centrifugation for optimal mononuclear cell recovery
- Cell viability consistently exceeding 95%, ensuring high-quality downstream applications.
- Flexibility in cryopreservation techniques, aliquoting, and sample preparation for advanced research needs.
- HEPA-filtered, ISO-classified laboratory spaces for sample processing under strict sterility conditions.
- Optimized spin cycles for PBMC integrity, ensuring consistent separation and purity.
- Comprehensive SOP-driven workflows, batch records, and deviation reports available on demand
- Digital chain of custody with real-time tracking for full sample traceability.
- 21 CFR Part 11-compliant data logging & audit trails to meet FDA and global regulatory standards
Contact Us Today
Phone: 256-236-0055 Ext. 102
Email: pinnacle@pinnacletrials.com
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