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

health-care
medical
pharmaceutical
project-management-db17

Nr. of Employees

small (1-50)

Bright Pharmaceutical Services

Sherman Oaks, California, United States, North America


Products

Full-service CRO for Phase I-III Clinical Trials

Bright Pharmaceutical Services offers comprehensive planning and management of Phase I-III clinical trials in the U.S. and globally, staffed by experienced clinical trial veterans to avoid costly errors and delays.

Patient Recruitment and Retention Services for Lupus Clinical Trial

Bright Pharmaceutical Services assisted in patient recruitment and retention for a 23-country clinical trial aiming to randomize 550 subjects across 65 global sites with a 16-month enrollment period.

Medical Device Regulatory Support Services

Bright Pharmaceutical Services provides support and guidance to medical device companies to navigate regulatory requirements and win product approvals, including preparation of necessary documentation such as CE Mark submissions, PDP, PMA, IDEs, and 510(k).

Biostatistical Services

Bright Pharmaceutical Services offers biostatistical and biometric services including statistical design, analysis, SAS programming, and reporting for clinical and non-clinical studies. They provide consultation, protocol statistical section development, sample size determination, study design, statistical analysis plan creation, programming of tables and figures, and support for data safety monitoring.

Clinical Trial Monitoring Services

Bright Pharmaceutical Services offers a network of highly-experienced monitors across the Americas, Europe, Asia, and the Pacific Rim, capable of taking on new projects with minimal lead time.

Medical Writing Services

Bright Pharmaceutical Services offers skilled medical writing services by experienced authors to convert clinical trial plans into concise, detailed, and comprehensible documents, supporting regulatory document submission and future publication.

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Services

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.

Preparation of study reports, regulatory documents and publication-ready manuscripts by scientifically trained writers experienced across therapeutic areas.

Program oversight, SOP development, project planning, tracking and reporting, financial management, risk assessment, and client liaison services.

Quality systems support including SOP development and execution, auditing and QA practices to support compliant clinical operations.

Safety monitoring and adverse event management throughout clinical programs.

Development and delivery of SOP-based training, investigator and site staff education, webinars and ongoing site evaluations.

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Expertise Areas

  • Clinical trial management
  • Clinical monitoring and site oversight
  • Regulatory compliance and submissions
  • Patient recruitment and retention
  • Show More (7)

Key Technologies

  • Electronic data capture (EDC)
  • Remote/centralized monitoring
  • Clinical trial management systems (CTMS)
  • Biostatistical analysis software (SAS/R)
  • Show More (4)

News & Updates

Case Study - DERMATOLOGY

Bright partnered with a large pharmaceutical company to manage and monitor an 80-patient trial on phototoxic potential, successfully meeting enrollment and data collection goals while saving costs.

Case Study - Oncology

Bright collaborated with a biotech company to identify, vet, and select investigative sites for a 78-patient phase II breast cancer trial, completing enrollment early and saving costs.

Case Study - Autoimmune

Bright partnered with a Top 10 pharmaceutical company to manage a 165-subject Phase IV trial on bioequivalence and pharmacodynamics, supporting rapid startup and flexible monitoring.

Case Study - Autoimmune

Bright supported a 6-site U.S. trial on allergic rhinitis, managing multiple protocol amendments and interim analyses with dedicated and flexible staff.

Case Study - Specialty Populations

Bright managed a phase I healthy volunteer trial with 400 subjects, ensuring timely data collection and supporting interim analyses.

Case Study - NERVOUS SYSTEM

Bright managed a complex, multi-year trial on uveitis with multiple protocol amendments, demonstrating flexibility and dedication.

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