On September 19th, 2019, Vinmec Times City International General Hospital was the first hospital officially acquired the “Good Clinical Practice” Accreditation Certificate granted by Vietnam Ministry of Health. This is a solid proof for the endeavor of Vinmec to standardize its system and meet the regulatory requirements for conducting clinical trials. This is also a cornerstone for further cooperation with other national as well as international companies/ organizations and partners to promote scientific research activities at the hospital.
According to Circular 29/2018 / TT-BYT: Regulations on Clinical Trials issued by the Ministry of Health on October 29, 2018, all medical facilities conducting clinical trial (CTs) activities must acquire GCP certificate. To be qualified for this certificate, a medical facility needs to meet an array of high requirements regarding personnel qualifications, operation of the local ethics committee, the infrastructure, medical equipment, clinical laboratories, procedures of reviewing and approving clinical trials, procedures of managing & ensuring quality of medical examination and treatment activities in general and special requirements in clinical trial etc.,
Although Vinmec is having a team of leading professors, associate professors, doctors, masters, specialists level 1 and 2 etc., who are experienced in conducting local clinical trials in Vietnam and international clinical trials, they are still constantly organizing training courses to update and improve knowledge about scientific research for its employees. Vinmec Hospital has collaborated with the Ministry of Health to organize two training courses on “Good Clinical Practice – GCP” in 2017 and 2018, and “Safety Reporting in clinical trials” in early 2019.
To date, 90 and 80 Vinmec employees has been granted with “Good Clinical Practice – GCP” and “Safety Report in clinical trials” training certificate respectively.
In addition, Vinmec always strives to improve the quality of healthcare services in Viet Nam following the strictest quality standards in the world. Vinmec Times City is the only hospital in Vietnam that has been accredited twice, in 2015 and 2018, by JCI (Joint Commission International) which was to appraise and certify international hospital with patient’s safety, quality of care and quality management system. In addition, the clinical laboratory system at Vinmec was recognized with ISO 15189 for laboratory tests on Hematology, Biochemistry and Microbiology.
Vinmec has been equipped with many advanced medical equipment, equivalent to those used by leading hospitals in the US, UK, Germany, Japan, Singapore … to maximize its support in diagnosis and treatment, as well as to meet the most stringent, rigorous testing requirements in clinical trials.
Vinmec is also focusing on developing standard operating procedure (SOP) systems for clinical trials related activities in order to meet regulatory requirements and comply with international regulations and guidelines.
Vinmec invests in developing a standard operating procedure (SOP)
With the aim of scientific research development, availability of an effective clinical trials supporting, organizing and implementing system along with the above-mentioned facilities and equipment, Vinmec Times City International General Hospital was selected by the Ministry of Health as the first site to perform GCP accreditation. Immediately after being granted with GCP certification, Vinmec cooperated with Astra Zeneca Pharmaceutical Company to participate in a phase II multicenter, multinational clinical trial evaluating the effectiveness of non-small cells lung cancer treatment. On top of that, Vinmec is also promoting and conducting clinical trials to evaluate safety and efficacy of stem cells therapy.
The official license to conduct clinical trials is an important milestone in scientific research activities of the Vinmec HealthCare System, helping Vinmec to further improve its scientific research in accordance with the local regulations and international guidelines. This recognition also opens opportunities for cooperation with pharmaceutical companies, Clinical Research Organization, individuals and organizations in the field of clinical trials having the desire to cooperate in researches of new & effective treatments.
