The electronic data capture system (EDC database) was established in 8 weeks

• The whole process from the finalization of the protocol to the launch of the EDC can be completed within 8 weeks. In order to ensure the high-quality and high-speed submission of the electronic data capture system, the following methods are mainly used:

  ◆ Standard operating procedures are strictly controlled and implemented

  ◆ The review and approval process is as simple and smooth as the factory assembly line

  ◆ Online Review Meeting and UAT

• We are the industry frontrunner and have the ability to build databases in all core EDC systems.We can provide global services ,including:

  ◆ BioKnow

  ◆ Medidata for Rave™

• Develop early plans for different functional teams so that we can complete database locking in 21 days.We provide continuous online data review and effective external data integration services.

  Identifying central trends and implementing risk mitigation strategies allows us to track the entire process. Unlocking after database lock can be reduced to the lowest level below 3%.

• We can integrate data from a variety of external platforms, including: laboratory data, ECG, safety data, ePRO and IxRS, and more. Data integration can save the need for multiple platforms.

• During trials, our proprietary technology platform collects real online data, enabling us to make better decisions and successfully implement clinical trial strategies and track data.

  The verification plan and plan deviation rules formulated according to the project situation, coupled with the efficient communication of each team, allow us to effectively review the data as a whole and identify central trends or potential risks in the early stage of the trial. Together with data management experts, we drive trial success by providing best operation process.

• Efficient teamwork, standardized operating procedures, and skilled application of domestic and foreign laws and regulations enable us to provide you with the shortest development time cycle, thereby reducing the input of manpower and material resources, and ultimately producing the most cost-effective results.

• One of the keys to success in your trials is having a data management team with extensive experience:

  ◆ More than 40 data management and database design professionals.

  ◆ More than 100 EDC completed trials,Involving stage I~IV,across various therapeutic areas.

  ◆ Save 50% of resource costs.

  At the same time, we have professional experts in CDISC/CDASH, and more than 40 team members have been trained in CDISC implementation.

• Equipped with technical experts that the sponsor can rely on. Provide flexible and high-quality consulting services according to the actual situation of the project.So as to issue a single or all-round integrated overall data management solution.

• Sending high-quality and meaningful data query quickly means you can make the right decisions early in your trial.Thereby protecting subjects and obtaining credible test results.

  ◆ Data management consulting and training

  ◆ EDC and paper project services

  ◆ Case report form design

  ◆ Database creation and testing

  ◆ Data management plan writing

  ◆ Data verification plan writing

  ◆ Logic verification programming and testing

  ◆ Electronic and manual verification of data

  ◆ Generation and resolution of data queries

  ◆ Data verification report

  ◆ Medical Coding

  ◆ Serious adverse event consistency check

  ◆ External data management (consistency check)

  ◆ Data quality control

  ◆ Data review report

  ◆ Blind data verification

  ◆ Database lock

  ◆ Data extraction and transfer

  ◆ Data management reports

  ◆ Data management file handover