Let’s imagine that OnlineCRF is configured and validated. User accounts are properly generated, and investigators enroll subjects and collect data. There are many hurdles on the way to successful data capture. Some study sites do not randomize subjects, some data are questionable and require forms or questions to remain blank. If some data are entered, they can be misleading or even incorrect. Adverse event forms are incomplete, or the next visit is overdue.
In reality, there should be a team dedicated to supervising site activity, identifying bottlenecks, creating queries and resolving them. Monitoring plans should be done to determine the frequency and volume of specific variables, which should also undergo a manual. Additionally, procedures should be created for data managers and clinical monitors.
If you are willing to outsource these activities to enhance data clarity and validity, we are ready to involve our Clinical Data Management department.
DM tasks that may be covered by our team:
- Supervise study site activity and identify available issues.
- Technical support for investigators.
- Monitor the completeness of the pages/visits.
- Remotely identify protocol deviations.
- Analysis of a series of numbers to identify outliers.
- Create queries and resolve them.
- Run manual checks.
- Perform medical coding.
- Clinical monitoring.
- Generate reports.
To perform the selected activities, we involve data managers, biostatisticians, medical monitors, medical advisers, remote monitors and subject matter experts (from a particular therapeutic area).
If you need an electronic data collection system and other monitoring activities are not requested, please visit the page OnlineCRF for Rent.
If you are looking for a broader spectrum of activities than those described above, please visit the page where a Full service is described.