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Post-Marketing Study

 

Overview

Further Surveillance of Safety and Efficiency in an Enlarging Population

All clinical studies for new drugs conducted after being approved by drug regulatory administration are post-marketing study. The main purpose for PMS would be further surveillance of safety and efficacy in an enlarging population. Therefore, reliable PMS results and reports will be more conducive to the long-term promotion and use of products in the market.

 

Features and Advantages

Dedicated to Authoritative Experts and TA for Large Multi-center Clinical Study

  • Solid expert resources/Extensive network of hospital specialists
  • Broad coverage of the executive team
  • Professional data quality management team
  • Abundant post-marketing clinical research experience
  • Diversified project cooperation platform

To Provide One-stop Solution to Large Sample Size Clinical Studies

  • Expert management:Academic conferences and training
  • Medical Writing:protocol writing and medical translation
  • clinical study management:on site monitoring, project management, call center,EDC&APP

 

Case Study

*As of Q1 2020

DYSIS Study- Dyslipidemia Survey(Prospective cross-sectional non-intervention study)

199 sites initiated within 4 months;More than 20,000 subjects enrolled within 8 months; big challenge for project management in large number of sites. Regional management mode is used under the overall control of PM. The partition PL follows up the project progress of each region respectively. After Regional PL reports the progress of the partition separately PM summarizes and reports the progress as a whole. Set recruitment target and followed the progress every week and every month, analyzed the reasons for the difficulty in recruitment and provided solutions. Conducted QC according to the progress and summarize findings on CRA training meeting; strengthen communication and training with investigators.

ASTRIS Study (RWS in oncology)

Nearly 80 sites initiated with 1,350 subjects enrolled with one year. The study design is complex, additional collection requirements are added in the process, which increased difficulty in execution. Set up 6 regional management, make reasonable plans and follow up closely, communicate fully with investigators, train study team with monitoring guidance documents to ensure key data quality.

Project Experience

*As of Q1 2020

75 post-marketing clinical studies (each enrolled 1000+ subjects)

Studies