CASE STUDY: OUTSOURCED QA DEPARTMENT
CASE STUDY: Outsourced QA Department
The Situation A small global biotechnology firm did not have a Quality Assurance (QA) department to oversee Phase II and III clinical trials across multiple therapeutic areasFurthermore, the firm required global audits for GCP, GLP, and GMP sites, vendors and CROs along with Trial Master File (TMF) audits and SOP development. QA auditing is essential in helping achieve compliance from the preclinical phase through commercialization. This process is particularly important in the pharmaceutical industry to ensure drugs consistently meet rigorous quality and safety standards. QA audits evaluate the client’s quality systems against the required standards to assess compliance and then allow deficiencies to be remediated. ClinAudits partnered with this client to provide a comprehensive QA department to ensure that quality standards were being met throughout the program.
The ResponseClinAudits, a global independent niche CRO, supported this client by providing a dedicated QA team comprised of a director and 5 senior compliance auditors for 4 yearsA project manager at ClinAudits oversaw the auditing operations and served as a liaison between the client and ClinAudits auditors. Audits were performed for Phase II and III clinical trials at more than 20 investigator sites globally. Additionally, ClinAudits developed SOPs, performed GLP and GMP auditing, and completed 5 global Trial Master files (TMF) audits. ClinAudits’ QA audit methodology was adapted to the client’s needs to execute these audits.
The Results By providing the client with outsourced QA capabilities, ClinAudits guided the client in achieving specific quality assurance goals without the need to recruit, train, and retain skilled personnel within their small organizationClinAudits’ ability to cater to this client’s specific needs fostered what did become a long-term partnership. ClinAudits provided this client with peer-reviewed reports, corrective and preventative action follow-up, and effectiveness checks following the auditing process. ClinAudits’ commitment to excellence cultivated a long-term relationship with this particular client for four years.
- ClinAudits’ global reach facilitates an efficient and reliable world-class service that delivers quality results without exception.
- ClinAudits’ dedication to client needs fosters long-term relationships that develop into steadfast partnerships through consistent results and execution.
- ClinAudits’ reputation for dedication to provide superior service, flexibility and responsiveness to client needs enables ClinAudits to earn repeat business with clients.
“Functional or specialty CROs…add value to sponsor organizations through access to expertise while at the same time retaining control over the process. They tend to be more flexible and have the ability to quickly respond to client needs.”11 Hammeke, K. “Strategic Outsourcing Often Means Combining Functional and Full-Service CROs.” Nice Insight. March 2013. Web. March 2016.