The Worldwide Epidemiology R&D Group of a large Pharmaceutical Company asked for help with their EMA requested Phase IV European Safety Study.
- EMA requested that electronic data capture be used to collect the safety data.
- The company’s CROs were having difficulty with the timeline requirement for patient enrolment and delivery of study analysis required by the European Regulator.
- The Company was unsure how to proceed until EMA suggested that they approach daCRO for help.
daCRO were asked to:
- Generate a list of prospective sites/investigators.
- Generate and execute confidentiality agreements with potential sites/investigators.
- Generate and execute site feasibility questionnaire.
- Nominate which sites/investigators to use.
- A Network Advisory Committee was established and significant protocol enhancements were achieved from physicians and nurses who would actually run the study.
- These changes were taken back to EMA and study time line was reduced from 2 years to one year.
- A total of 300 European sites in 30 countries were evaluated using our standard site feasibility tool.
34 sites from 10 countries were accepted from the 300 sites assessed.
All Sites chosen:
- Had experience to run study.
- Saw sufficient patients to meet eligibility criteria and therefore would enrol 100 patients within 12 months.
- Had no current or planned research studies with the same target population that would compete.
- Sites/investigators were informed that patients would be recruited.
25 sites from 10 countries provided 105 patients on a competitive first come basis.
By acting as a patient recruitment accelerator we were able to help the Company and their CRO to:
- Achieve patient enrolment well within the original timeline not achievable by the CRO alone e.g. 105 patients were recruited within 6-months.
- Achieve study analysis and writing of final report well within original timeline requested by EMA.
“ The success in running this study should be viewed in the context that our CRO were unable to achieve our patient recruitment goals by themselves ”