Quality Assurance

Quality is not an ambition, it is a lived reality. No matter what kind or what size of a clinical trial, quality is the core of everything we do in every step of the process. At Tigermed, our QA team is independent of clinical operations, we collaborate with operation teams and clients to ensure compliance with the protocol, SOPs, and regulatory guidelines. We offer comprehensive quality services to support and enhance a compliant clinical research, and help to assess the quality and risk of the clinical trial activity, data, statistics, vendors etc.

70+

Vendor audits

700+

Audit programs

2,000+

Onsite audits

300+

Customers

40+

In-house auditors

30+

Onsite inspection support

3rd Party Audit

Service Scope

Audit services for Phase I-IV clinical trial, medical device clinical trial, IVD, BE study, PK study, data management, TMF, etc.
Audit services for external vendor and NMPA onsite inspections. GCP / GLP / GMP audits.

Complete Process

We design complete working process and give you a clear pathway for successful audit
Full audit service including preparation, onsite inspection, report writing, CAPA planning, etc.

Team of Experts

30+ professional auditors, 15 experts in key areas like bioanalysis, biometrics, protocol, pharmacovigilance, medical imaging, IT, etc.
65% of our auditors have 6+ years of auditing experience.

QA Support Service

QA routine works

Review and finalize key study documents
Daily communication and consultancy
Attend project meetings regularly, join the discussion of study issues and corresponding CAPA plan
Review the responses to external audit reports
Attend regular quality review meeting

Audit Service

Design the audit plan
Conduct audit
CAPA plan review and follow-up
Audit Observation Sharing and training

Inspection support

Participate in the Self-inspection
CAPA plan review and follow-up
NMPA inspection preparation
On-site inspection support
Post-inspection follow-up support

Training Service

In addition to the routine courses, the training courses can be customized according to issues in the study and different trainees.

Monitoring Skill Training for CRA

Project Management Training for PM

Investigator Training

Audit Skill Training for QA

QMS (Quality Management System) Consulting Service

QMS audit: Gap analysis of existing systems to assess compliance and efficiency
QMS training: 1) QMS knowledge training, 2) SOP writing and framework.
Consultation on QMS set up: Remediation of gaps in existing systems
Nearly 10 overseas/domestic CRO QMS audit, gap analysis for many innovative pharmaceutical companies, and provide remediation suggestions

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