Our experienced auditors conduct audits for site qualification, project management, monitoring, study documentation (Essential Documents, Informed Consent, Source Document Verification, Investigator Logs, Safety Reports) for Phase I-IV studies, to check their compliance to the protocol and GCP; and to assure site adherence to applicable SOPs (Standard Operating Procedures) and Regulatory Guidelines.
Our highly experienced staff takes responsibility for coordination, scheduling, hosting, and management of regulatory inspections from an exceedingly early stage so that you do not have to worry about the inspection. We have experience hosting regulatory inspections for all major Regulatory Authorities e.g., FDA, MHRA, EMA, PMDA, KFDA, HSA, TFDA etc.
- Mock Inspection
- Preparation and Training
- Inspection Hosting
Our highly qualified team of expert auditors have worked on different projects globally and nationally to assess all types of vendors for selection according to the needs of our clients. With an average experience of more than 15 years, we have successfully conducted vendor audits to ensure their compliance as per the given SOP and requirements.
Our team of auditors check data management systems and processes used for documentation. These are conducted to ensure that all data is validated and entered in accordance with protocol and to ensure data protection before the close-out of the study.
- Database
- Data Management System
- Data Managing Process
We carry out audits for TMF documentation to ensure all the documents are properly filed/stored and verified/archived as per GCP and study plan/protocol along with the site file, for future inspections.
We work with our clients closely to cater for their project-based needs and assign our highly skilled CAPA manager per the project needs and task. We offer services relating to CAPA development, CAPA management and Root Cause Analysis. We ensure that CAPA evidence is provided, and effective actions are taken within the provided timeline along with CAPA reports to keep Sponsor/CRO updated and to identify trends and challenges.
OrciTrials standing by its motto “Spirit of Perfection” ensures to provide its partner and client with top-notch services, by maintaining quality within its team through continuously updated processes and trainings along with the quality focused environment.
Yvonne Li
Quality Assurance Auditor 360CQA
“Ms. Li, a Quality Assurance Professional, holds extensive experience of 18 years in Clinical Research and Auditing services compliant to GCP. Her specialty lies in Risk Management, Vendor Management and Performance Management. She has worked with multiple CROs across the globe to deliver quality compliant services in Singapore, China, Indonesia, Philippines, Malaysia, and Australia.”
360CQA is our partner organization, a China based consulting company providing Quality Assurance and Quality Management Services. It specializes in conducting Audits based on the principles of GCP, GCLP, GVP, GDP and GMP. It has conducted more than 350 audits in 12 different countries.
OrciTrials together with its partner 360CQA, provides its clients with GCP compliant services ensuring cost effectiveness and high-quality outcomes. We provide services tailored to the needs of our clients to help them excel in the market with top-notch results.
OrciTrials together with its partner, 360 CQA, is delighted to serve you.
