Quality First, Always
Biorasi’s processes and procedures were built from the ground up to put quality first. Our Quality Assurance team continuously assesses every component of our organization to ensure that we meet or exceed the highest standards of Good Clinical Practice (GCP). Biorasi is constantly evolving and improving, always under the guidance of quality first.
Quality Assured, Inside and Out
Our quality team audits our internal functions as well as our sponsor studies to make sure that plans and SOPs are adhered to and that every activity is performed correctly and documented accurately. Our quality teams are rigorously trained, meticulously detail-oriented, and contribute to making Biorasi a leader in quality assurance and regulatory compliance.
Our Quality Assurance services include:
- Risk management planning
- Site and vendor qualification and auditing
- Study trial master file audit
"One of the rarest events, where we had to communicate [to Biorasi] to stop the screening rather than boost it."VP of Global Clinical Development, Top Specialty Pharma
Latest News and Blogs
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a...
Introduction Clinical trial rescues can often be a delicate topic for both sponsor and contract research organization. When a study goes off track, it’s natural to want to point fingers and look for who is to blame. However, performing a comprehensive root cause...