China, a fast growing place for clinical trials
In China, clinical trials are regulated by the State Food and Drug Administration (SFDA).
In the last decade, SFDA has issued several regulations that have streamlined and clarified the process of approval and conduction of clinical trials.
Since 2004, clinical trials can only be conducted in SFDA GCP certified institutions. Currently, there are over 400 institutions certified for clinical trials. Most of them located in main cities like Beijing, Shangai, Guandong, Jiangsu and Shangdong.
Conducting clinical trials in China could be up to 75% faster thanks to its huge patient population base with therapeutic diversity and well trained and enthusiastic investigators. Other factors as listed below, contributes to make China a perfect localization for participating in global drug development programs.
For many reasons, China is increasingly identified as a major resource center for conducting trials:
- Size of the population
- Large diversity of patient population and disease states
- Large pool of treatment-naïve patient
- Level of literacy is high especially in urban populations
- High retention rate due to the strong relationship between patients and healthcare providers
- Continuously increasing base of GCP-trained investigators
- Experienced and motivated investigators
- State-of-the-art medical and hospital
- Potential for cost savings compared to western countries
SMO-CLINICA China, located in Beijing, is a subsidiary of SMO-CLINICA SAS, holding across the whole country, a network of affiliated investigative sites and employees acting mainly as Clinical Research Coordinators, Study Nurses and other Research Staff.
SMO-CLINICA China aims at performing Clinical Research in China by leveraging access to patients while guarantying high standards of Quality and Ethics.
SMO-CLINICA's management sets high standards for the operations of the company based on western management practices and client-oriented approach.
The success of our model is based on our collaboration with SFDA certified investigative sites. These sites, thanks to dedicated facilities, are complemented with permanent Clinical Research Coordinators (CRCs) and Study Nurses. The CRCs and study nurses are assigned to sites on a permanent basis supporting Principal Investigators in the management of patients and in administrative activities.
Examination rooms, investigational drug storage, laboratory space, necessary medical equipment, CRF storage area, and sufficient office space for monitors make our Investigative Sites a truly research friendly environment.
SMO-CLINICA does address Sponsors' concerns through its unique business model ensuring the on-time "delivery" of the committed number of patients associated to a high retention rate and at competitive costs thanks to our Investigative Sites.
BDA Xihuan Nan Lu No.18
Building A, 3rd Floor
People’s Republic of China
Contact us at: firstname.lastname@example.org