FAST-TRACK drugs & biologics, LLC
Contract research organization founded in 2003 that provides clinical development, regulatory strategy, clinical data management/biostatistics, and quality/compliance support for vaccines, biologics, cell and gene therapies, and small-molecule therapeutics. The organization focuses on accelerated product development pathways including preclinical planning, IND/BLA/NDA support, and multi-site clinical trial management for government and commercial clients.
Industries
Nr. of Employees
small (1-50)
FAST-TRACK drugs & biologics, LLC
20010 Fisher Avenue, Suite G, Poolesville, Maryland 20837
Products
Clinical Trial Design and Management
Service for planning, organizing, and overseeing clinical trials to evaluate vaccines and therapeutics.
Data Management, Analysis, and Reporting
Service for handling clinical trial data including collection, processing, analysis, and reporting of results.
Regulatory Services
Support services to navigate regulatory requirements for product development and licensure.
Clinical Trial Design and Management
Service for planning, organizing, and overseeing clinical trials to evaluate vaccines and therapeutics.
Data Management, Analysis, and Reporting
Service for handling clinical trial data including collection, processing, analysis, and reporting of results.
Regulatory Services
Support services to navigate regulatory requirements for product development and licensure.
Services
End-to-end clinical trial services including protocol writing (Phase 1–4), site selection and management, monitoring, enrollment/randomization, and study operations.
Design and deployment of EDC/eCRF systems, customized databases, real-time data collection, data validation, statistical analysis plans, and study reporting.
Regulatory planning and preparation of INDs, BLAs, NDAs, drug master files, pre-IND packages, FDA presentation materials, and meeting support.
Development and oversight of quality systems and performance of GCP, GLP, and GMP compliance audits for clinical programs and laboratories.
Strategic planning for product development including non-clinical study plans, formulation and process development, and support for biodefense countermeasure development.
End-to-end clinical trial services including protocol writing (Phase 1–4), site selection and management, monitoring, enrollment/randomization, and study operations.
Design and deployment of EDC/eCRF systems, customized databases, real-time data collection, data validation, statistical analysis plans, and study reporting.
Regulatory planning and preparation of INDs, BLAs, NDAs, drug master files, pre-IND packages, FDA presentation materials, and meeting support.
Development and oversight of quality systems and performance of GCP, GLP, and GMP compliance audits for clinical programs and laboratories.
Strategic planning for product development including non-clinical study plans, formulation and process development, and support for biodefense countermeasure development.
Expertise Areas
- Clinical trial management
- Clinical data management and biostatistics
- Regulatory strategy and submission writing (IND/BLA/NDA)
- Biologics and cell & gene therapy development
Key Technologies
- Electronic data capture (eCRF) and clinical informatics
- Biostatistical analysis (SAS / S-Plus)
- Laboratory Information Management Systems (LIMS)
- Assay development and analytical method validation