Bright Pharmaceutical Services
Bright Pharmaceutical Services is a privately-held full-service Contract Research Organization founded in 2002, serving clients ranging from startups to large pharmaceutical, device, biotech companies, and government entities. Headquartered in Los Angeles, California, it operates globally, supporting research trials across various therapeutic areas and development stages with full service or à la carte plans. The company emphasizes innovation, integrity, and customer-first values, aiming to be a trusted source of critical information and insight, and to contribute to advances in medical science, health, and longevity.
Industries
Bright Pharmaceutical Services
Sherman Oaks, California, United States, North America
Services
Regulatory Support
Consulting and document preparation for regulatory interactions and submissions (IND/IDE, NDA, BLA, 510(k), PMA), FDA/IRB communications, and compliance with GCP/GMP/GLP and 21 CFR Part 11.
Medical Writing
Preparation of study reports, regulatory documents and publication-ready manuscripts by scientifically trained writers experienced across therapeutic areas.
Program and Project Management
Program oversight, SOP development, project planning, tracking and reporting, financial management, risk assessment, and client liaison services.
Quality Management
Quality systems support including SOP development and execution, auditing and QA practices to support compliant clinical operations.
Safety and Pharmacovigilance
Safety monitoring and adverse event management throughout clinical programs.
Training and Site Education
Development and delivery of SOP-based training, investigator and site staff education, webinars and ongoing site evaluations.
Regulatory Support
Consulting and document preparation for regulatory interactions and submissions (IND/IDE, NDA, BLA, 510(k), PMA), FDA/IRB communications, and compliance with GCP/GMP/GLP and 21 CFR Part 11.
Medical Writing
Preparation of study reports, regulatory documents and publication-ready manuscripts by scientifically trained writers experienced across therapeutic areas.
Program and Project Management
Program oversight, SOP development, project planning, tracking and reporting, financial management, risk assessment, and client liaison services.
Quality Management
Quality systems support including SOP development and execution, auditing and QA practices to support compliant clinical operations.
Safety and Pharmacovigilance
Safety monitoring and adverse event management throughout clinical programs.
Training and Site Education
Development and delivery of SOP-based training, investigator and site staff education, webinars and ongoing site evaluations.
Expertise Areas
- Clinical trial management
- Clinical monitoring and site oversight
- Regulatory compliance and submissions
- Patient recruitment and retention
Key Technologies
- Electronic data capture (EDC)
- Remote/centralized monitoring
- Clinical trial management systems (CTMS)
- Biostatistical analysis software (SAS/R)