Quality Assurance

At KlinEra, we understand that quality must be intentionally performed, assessed, and promoted. KlinEra’s dedicated Quality and Compliance team have extensive experience in conducting all types of audits on a Global basis. We implement quality by system-based approach to the design, development and delivery of services to our clients.

KlinEra brings you quality control measures aligned with your QA requirements, namely, trainings, co-monitoring, quality oversight visits, document review and consulting as well as robust audit programs to ensure your success.

In addition to a comprehensive internal clinical quality assurance program, we provide clinical QA & QC services to our clients as a part of either a full-service or a stand-alone project. These include but not limited to:

• Auditing all aspects of regulated operations with expertise in compliance assessments in GCP and GLPSystem audits, in which we assess SOPs, staff training program(s) and procedures.
• Study site audits: Routine, directed, specialized and pre-inspection to help the sites to prepare for regulatory inspections.
• Clinical study document evaluation. Vendor audits, in which auditors evaluate vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations.
• Quality oversight visits to provide you with independent review of your sites and staff performance as well as recommendations for improvement.
• Regulated training and education

“It is QUALITY rather than QUANTITY that matters”