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”
Interested in KlinEra?
KlinEra Global Services
KlinEra provides innovative, customized clinical trial and research services.
311-313 Piercy Road San Jose,
P : (408) 365-3231
F : (408) 365-3232
801, Neelkanth Corporate Park,
Vidhyavihar West, Mumbai 400086.
P : +91 22 2509 1470
F : +91 22 25004588