Our Clinical Study Team
With extensive clinical study management and clinical data management experience in medical and pharmaceutical research, our global CRO team has successfully organized many multinational multi-center clinical trials, sponsored by some of the top 50 pharmaceutical companies. Our team has conducted over 200 trials in 18 therapeutic areas, performed at more than 600 hospitals in 40 cities, involving more than six- hundred thousand (600,000) patients.
- Our Clinical Trial Operations team (CTO) is overseen by our Chief Operations Officer (COO) and composed by Clinical Operation Director, Project Manager, CRA Manager, CRA Training Manager, QC Manager, TMF Manager, and the EC/IRB Manager.They are allocated in 23 sub-offices across China major cities and in the U.S. in Union NJ.
- Our Medical Directors and Project Managers hold Masters or Doctoral degrees in medicine and relevant areas. All have many years of experience in medical or/and pharmaceutical research with multi-national pharmaceutical companies.
- All CRAs have medical degrees, masters, and/or pharmacy degrees, and have received strict and intensive ICH and GCP training; all CRA’s are experienced in clinical trials and have the capability of working independently.
Our Clinical Trial Services
- ShujuMetrics has large site and investigator databases in all therapeutic areas, specifically in CNS, Cardiovascular,Schizophrenia, Endocrinology, Diabetes, Pediatric, Immunology and Oncology
- ShujuMetrics has extensive experience working with the GCP center, which plays a critical role in overall study management
- ShujuMetrics screen sites using criteria in accordance with international requirements
- Study materials training
- Therapeutic area training
- Study drug training
- Project Kick-off Meeting Training
- Project Management
- Project management plan (PMP) draft, review and finalization
- Implementation of project management plan, including monitoring plan, communication plan and risk management plan
- Fast escalation and resolution strategy for monitoring issues
- Conduct monitoring visits based on monitoring plan
- Source data verification (SDV)
- ISF management
- Investigational product management
- Data Clarification Form resolution and retrieval
- Site Close-out
- Quality Control & Standards of Process (SOP)
- Detailed and clear SOPs that ensure the quality consistency of the clinical operation
- QC team creates the QC Plan based on project requirements, ensuring the quality of CRA review
- Independent QC department ensures strict compliance to SOPs
- Independent TMF team ensures the retrieval and storage of study documents