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Home
Clients
Clinical Trials Sponsors
CRO Partners
Post-marketing Clients
Services
ICSR
Aggregate Safety Reports
Risk Management
Safety Signal Detection
Clinical Trials Safety Services
Pharmacovigilance (PV) Training
Other Safety Expert Services
About Us
Contact Us
Clinical Trials Safety Services
Our safety team excels in offering a variety of clinical trials safety services.
Medical safety monitoring (Phase I-IV)
Assisting in assessing subject eligibility (e.g., incl. or excl. criteria)
Evaluating study protocols and informed consents
Assessing the benefits and risks on an ongoing basis
Good clinical practices (GCP) training
Safety monitoring and review
Analyzing and reporting SAEs/ESRs/SUSARs
Identifying safety signals and safety trends
Monitoring subjects’ safety throughout the trial
Assessing and ensuring regulatory compliance
Study documentations review
Annual safety report, annual IND report
IB development and update
Integrated summary of safety (ISS), summary of clinical safety (SCS),
Assisting in development of study protocol, informed consent form, case report form, SAE form, study reports
Other clinical development services
GCP Inspection support and training
Regulatory Clinical Trial Support and Strategic Consultation
Data Management
Quality Assurance
