Working with specialists and advisors, Expro is responsible for drafting clinical trial protocol, case report form (CRF), informed consent form and other documents.
Expro is responsible for clinical trial center screening, meeting organization, project registering, contract signing and other preparations before the initiation of each clinical trial center and organizing and making arrangement for the formal kick-off of each center.
Expro clinical trial team puts a high premium on the initial training for all investigators before the initiation of clinical trial centers and highlights the important role of principal investigator in the implementation of the clinical trial.
Expro clinical trial team monitors the clinical trial according to the requirements of GCP, clinical trial protocol and SOP in routine monitoring, preventing, finding and solving problems timely and effectively. Expro will increase monitoring frequency at least for the first two months to ensure that all investigators can operate according to the protocol.
By means of co-visit, the project manager of Expro clinical trial team directs and controls the work quality of clinical research associates so as to ensure the quality of the clinical trial.
In the process of drafting protocol, Expro clinical trial team will communicate with the specialists, advisors and investigators about the potential risks and work out corresponding measures. During the period of clinical trial, Expro clinical trial team will keep an eye on the unexpected risk factors and once detecting them, investigate them and recommend solutions and control measures in time.
By means of co-visit, the project manager of Expro clinical trial team directs and controls the work quality of clinical research associates so as to ensure the quality of the clinical trial.
The quality controller of Expro clinical trial team performs in strict accordance with the requirements of SOP and provides corresponding guidance or training to the clinical research associates so as to ensure the quality of the clinical trial.
In the process of drafting protocol, Expro clinical trial team will communicate with the specialists, advisors and investigators about the potential risks and work out corresponding measures. During the period of clinical trial, Expro clinical trial team will keep an eye on the unexpected risk factors and once detecting them, investigate them and recommend solutions and control measures in time.
After completing the first draft of the clinical trial report, Expro clinical trial team will invite the specialist, advisors and investigators to improve the report so that the report can presents a faithful and accurate account of the data and characteristics of the product and meet the submission requirements issued by China National Medical Products Administration (NMPA), so as to provide assurance to its approval by NMPA and its launch in Chinese market.
