Clinical Quality Assurence
Quality Assurance Quality Control / Management Risk Management
OrciTrials offer specialized services of Quality Assurance and Quality management to its clients to maintain GCP (Good Clinical Practice) compliance and integrity of data. Our highly qualified and experienced Quality Assurance team have worked on multiple clinical studies in collaboration with our partner in different countries like Singapore, Pakistan, UK, China, and other Asia-Pacific countries. We provide a wide range of onsite as well as remote quality assurance services starting from the process of study startup and feasibility till the completion. Our services include:
Our Services Include:
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.
Meet Our QA Expert and Partner
Meet our quality assurence auditor and quality assurence officer, and have the best experience
Quality Management System
Quality Management System
OrciTrials is ISO 9001 Certified. At OrciTrials , we’ve always been committed to excellence. We’ve met and exceeded these standards to ensure that every project we undertake is executed with the utmost precision quality.
1. QMS compliant with the below requirements:
2. Defined procedures for QA activities to cover all project and deliverables including a defined schedule for execution.
3. Vendor qualification process based on a risk management assessment including but not limited to:
Compliance With Global
Standard Quality
- Improved Quality
- Streamlined Processes
- Compliance Assurance
- Enhanced RBQM
- Data Integrity
