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OC/RDC implementation of clinical trials
发布时间:2019-01-07    浏览次数:612    发布者:H&J (Group) Corporation

June 2015

 

In 2011, Han Bo Rui Qiang took the lead in buying Oracle EDC in China: the Oracle Clinical/RDC/TMS system developed by Oracle Corp, which bought a permanent right to use at a high price.

 

1. the Danish NNIT, which is certified by Oracle Corp, carries out IQ, OQ and PQ certification for oracle bone inscriptions. Through a number of multinational pharmaceutical companies strict IT inspection (Auditing).

 

2. the Disaster Backup (DB) system of the Oracle Oracle Clinical/RDC/TMS system was deployed in the IT room of Shanghai and New Jersey.

 

3., "double channel optical fiber" and "two way power supply" are adopted.


4., the completion of Oracle OC/RDC's sinicization, China's first.

 

5. two development: developing a number of automation functions on the basis of the original OC/RDC, greatly improving efficiency, avoiding human errors, and significantly reducing the use cost of R & D institutions.

 

 

 

Successful case

 

The following is the case and achievement of the OC/RDC implementation of the Han Rui Qiang Oracle Bone Inscription: by the year June 2015, there were 19 online clinical trials, of which 6 were clinical trials in the US Sponsor (English OC/RDC).

 

1. a double-blind, multicenter, placebo-controlled, IIb clinical trial of XXX efficacy and safety in the treatment of advanced metastatic skin cancer with XXX. Center: 7 centers in North America (USA, Canada). Cases were included in 1/3. at the end of February 2015 (English OC/RDC).


2. a randomized, double-blind, multi dose parallel controlled, placebo-controlled phase II trial of XXX in the treatment of attention deficit disorder in 3-10 year olds. Center: 9 centers in the United States. The inclusion of cases at the end of February 2015 has been completed. (OC/RDC)

 

3. efficacy and safety of oral XXX and Paclitarel Injection in the treatment of advanced metastatic breast cancer: a multicenter, multicenter, randomized, open label III clinical trial. Center: 28 centers in South America and Central America, the United States, Argentina and Venezuela. (English OC/RDC)

 

 4. China cardiovascular disease medical quality improvement project (CCC project) (http://www.ccc-heart.com): sponsored by the China Health Planning Commission and the Chinese Academy of Cardiology, funded by the American Heart Association and led by the famous cardiovascular expert, Professor Zhao Dong, director of the Institute of cardiovascular diseases, An Zhen Hospital, Beijing. A total of 150 three grade A hospitals participated in the study. 30 patients with acute coronary syndrome (ACS) and 20 patients with atrial fibrillation (AF) were enrolled every month. Two years included 108 thousand patients with ACS and 72 thousand patients with AS. In March 2014, John Bodry Jon successfully bid from 9 competing companies and the long and difficult 4 round knockout. By the end of February 2015, thousands of patients had been included. At present, the rate of 4500 cases of ACS is quickly incorporated into the case. (Chinese OC/RDC)

 

5. XXX prospective, open IV phase clinical study on chronic back pain and skeletal muscle pain: 3600 cases were included in 37 centers nationwide. The inclusion of cases at the end of February 2015 has been completed. (Chinese OC/RDC) 

A prospective and open clinical trial of 6. XXX in the treatment of advanced non small alveolar lung cancer: 3000 cases were included in 47 centers nationwide. The inclusion of cases at the end of February 2015 has been completed. (Chinese OC/RDC)