​​​​​​​​Case Study 1 - CRO and Clinical Data Management Services


​​Background:

After 5 competitive rounds of bidding with 8 major CROs in China, our partner, H&J CRO International, won The China Get with the Guideline (GWTG), project named Improving Care for Cardiovascular Disease in China (CCC). It was co-sponsored by American Heart Association (AHA) and Chinese Society of Cardiology (CSC) under the leadership of China Ministry of Health (MOH). Get with the Guidelines-CCC is the nation’s largest quality improvement program focused on Cardiovascular Disease. The key success factor of the CCC project is to see the degree of the Guideline Compliance of the participating hospitals by analyzing the parameters of the individual hospital to the national results in average. The program can lead to improved outcomes and lower readmission rates – benefiting patients and hospitals alike.

Challenge:

  • The initial plan was to recruit 108,000 Acute Coronary Syndrome (ACS) patients, 72,000 Atrial Fibrillation (AF) patients          consecutively from 150 China cardiology hospitals in the next two years.
  • When the project was awarded, there were only two months left before all the following had to be done:
  1. Complete the design, the text editing, and the production of the study-specific website (www.ccc-heart.com). (At the time the name of the website was not determined, or registered).
  2. Complete protocol design (draft writing), discussing details with CCC members
  3. Complete all the other study material such as base-CRF, ICF, Dossier for EC committee within 6 weeks
  4. Finishing Oracle Clinical e-CRF design, edit-check programming, and UAT in two weeks
  5. Complete all the 150 sites qualification assessmen
  6. Complete all the training material for investigator meeting
  • Deliver 151 reports MONTHLY, based on clean data, statistically comparing the results of hundreds of parameters from        the individual hospital to that of the nation-wide average, and generating thousands of figures and tables


Solution:

  • H&J project manager united all the man-power within company, from IT to medical director, from logistic to finance                department, from medical monitor to CRA, from biostatistician to SAS programmer, data manager to EDC engineer, all          cross-functional teams worked as one team under the leadership of the project manager
  • H&J Innovation Center made up by the Directors of IT, SAS Programming, Bio-Statistics, Medical Department along with      consulting professors from Beijing Institute of Technology and the staff of the Innovation Center were dedicated to work on    the issue of how to get clean report data for processing and analysis. After five weeks, the issue was resolved by writing        programs to automatically process and analyze  the clean data as soon as it is exported from Oracle Clinical


Results:

  • H&J completed all the above work within TWO MONTHS.
  • The Oracle Clinical EDC database was online in time for the study start
  • The 'ccc-heart.com' domain name was registered, the website built (www.ccc-heart.com) and online according to schedule
  • All the 151 individual report could be automatically generated, published as pre-set format within 90 minutes!  In addition,      all the reports automatically go to the respective hospital-specific folder.
  • The project manager from AHA, Louise Morgan, was astonished by H&J efficiency, "Unbelievable", she said.
  • Dr. Sidney Smith, Chairman of the World Heart Association and Ex-AHA chairman, spoke highly to H&J innovation. "Very      impressive", he said.
  • As of Jun 2015, the project has recruited 12,000 ACS subjects, and 600 clinical reports has been generated, without an        error!