Introduction of Clinical Operation Department

The Department of Clinical Operation was established in 2019. It integrated the function of GCP Office, Quality Management Department and Central Pharmacy, mainly responsible for DCTC daily work, management of registered clinical trials (drugs and medical devices), CRC management, operation of central pharmacy, etc. There are 8 full-time employees.

Optimize Management Process, Accelerate Initiation of Clinical Trials

We have established a pre-review model for clinical trials in 2019, which means we and Ethics Committee could review the materials of clinical trials before sponsors received IND approval. Meanwhile, HGR materials (if necessary) and contract could be prepared as well. The total time for SSU stage will be shortened by 1-2 months. In 2020, another new "one-on-one" service model was established for continually accelerating the SSU stage, especially for first class innovative drugs and medical devices, also for clinical trials initiated by Beijing enterprises. The clinical trial could be approved within 1 day; ethical and HGR review could be within 7 days; review and signature of the contract could be finished within 10 days. A clinical trial expert team was also established to provide technical support, a specialist team to support accelerating ethical review and contract review .

Accelerate Initiation of Clinical Trials for Leading Site

In 2022, Clinical Operation Department collaborated with EC to assist in improving quality and efficiency of clinical trials for leading site. We could participate in developing R&D strategy, writing protocol, amending ICF document, and training the whole research team. At the early-stage of clinical trials, we arrange someone to attend kickoff meeting and communicate risk factors of the project. During the patient enrollment stage, we will hold regular meeting to communicate issues with PI, sponsor, CRC, etc. for ensuring the quality of clinical trials. For example, we only took 59 days to start up a clinical trial for leading site in Respiratory Medicine Department, due to all the favorable policies.

Quality Management for Clinical Trial

Following Risk-based Quality Management concept, we use information technology, and standardized indicators to control source data quality. Meanwhile we train our research teams , including PI, Sub-I, study nurse, CRC, etc. to improve their capabilities to carry out the trials in a right way. For CRC, we have a comprehensive evaluation and management system, ensuring the quality and efficiency of CRC service. We passed all inspections from CFDI and have good reputation from industry peer.

Centralized Management of Clinical Trial Drugs

The Central Pharmacy was established in December 2012, responsible for the centralized management of clinical trial drugs. It has a professional, standardized, streamlined and systematic management system, which guarantees the quality of clinical trials in the hospital from the source, and is highly recognized by researchers, sponsors and drug regulatory authorities. From 2015 to 2018, the national continuing education program training course of "Clinical Trial Center Pharmacy Construction and Management" was held for four consecutive years, attracting 342 trainees from 187 sibling units across the country. The clinical trial Center pharmacy has played a leading role in the domestic industry with its standardized/diversified technical service model, and won the title of the first "Demonstration Unit of Clinical Investigational Drug Centralized Management Project" in China.