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Overview
SCRC has created a one-stop customized service package that has capabilities for phase I to phase IV clinical trials. Our comprehensive range of services covers the full spectrum of clinical development in compliance with ICH-GCP and Chinese GCP. We have a distinguished team of experienced professionals who bring an in-depth expertise from industry, research institutes and hospitals. We know what it takes to bring your new product to the market efficiently and cost-effectively, and we'll help you make it happen.
Services
| Regulatory Affairs: |
• Consultation on strategic, regulatory, scientific and safety aspects of clinical development in China
• IND, NDA and import license applications
• Strategic regulatory advice and drug development plans for the Chinese market
• Link with regulatory authorities
• Professional preparation of medical reports, summaries, and other product information
• Expertise in global regulatory affairs |
| Phase Ⅰ-Ⅱa Studie: |
• Safety and dose escalation studies
• Pharmacokinetics / pharmacodynamics studies
• Bioavailability / bioequivalence studies
• Pharmacogenomics studies
• Ethnic sensitivity evaluation
• Age, gender and food effect as well as drug - interaction studies
• Hepatic and renal insufficiency studies |
| Phase Ⅱb - Ⅲa Studies: |
• Hospital network for oncology, CVS, CNS, endocrinology
• Project management
• Scientific protocol writing
• Active participation in follow-up monitoring to support long-term retention
• Flexible resourcing for evolving project needs |
| Phase Ⅲb and Ⅳ Studies: |
• Post-marketing study design
• Post-marketing research training |
Competitive Advantages
Professional team:
Over 20 experienced scientists, experienced CRA and clinical trial managers are led by Dr. Jack Xu, senior VP of SCRC, who has more than 15 years' experience in clinical research.
State-of-the-art facilities:
Over 4500 square meters working areas equipped with the most advanced facilities of the industry include a central lab.
Premium quality and high efficiency:
Through multiple layers of management, including specified SOPs, systematic QC. SCRC has invested heavily to develop its own proprietary technology for management of clinical trials.
Cost-effective solution:
To connect customers to the well-trained research workforce and save your cost. |
