简体中文    |    English    |    Français
 
  Home About SCRC CRO Services Public Services News & Events Career Volunteers Social Commitement Contact Us  
 
 
CRO Services
Clinical Development (Phase I-IV)

Phase Ⅰ Clinical Research Unit

DM & Biostatistics

Central Laboratory

 
Clinical Development (Phase I-IV)

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.

 
 
Copyright 2008-2018 Shanghai Clinical Research Center All Rights Reserved
Address: 18F, Building A, 380 Fenglin Road (Fenglin International Centre), Xuhui District, Shanghai 200032, P. R. China
Tel: (86) 21 3367 6666 Fax: (86) 21 3367 6373 Email: info@scrcnet.org
Shanghai ICP #09015724