Feasibility & Study Start-Up
Clinical development continues to become more complex driving the need for additional clinical monitoring models.
The movement away from the traditional model of regular site visits can be a cause for concern to some sponsors. Cmed can help as we understand the practicalities of choosing a monitoring model for your clinical trial.
Tailored to meet your needs
At Cmed, we develop our monitoring strategies by working with you to assess the many aspects of the study including risks, critical endpoints, participants, the investigator sites etc. and determine the optimal approach. We also recognize that clinical trials are dynamic meaning we can fluidly transition monitoring strategies based on the trial’s needs. The clinical monitoring models provided by Cmed include:
- Data Driven
- Frequency based (example, visits every 4 to 6 weeks regardless of site activity)
- Traditional monitoring: 100% onsite or offsite site source document verification/source document review
- Risk-based monitoring: An onsite or offsite monitoring strategy reflecting the participant, site type, study complexity, risk thresholds and mitigations that, in some situations, can reduce monitor time.
- Reduced source document verification or source document review: see risk base monitoring above.
- Remote monitoring: offsite review of data by clinical and data management team members to identify data anomalies without source documentation present. This is used between monitoring visits to optimize CRA time expenditure.
Cmed’s encapsia technology increases clinical monitoring efficiency by:
- Use of sophisticated data insights which can be actioned within our technology, encapsia is used to support all monitoring efforts. encapsia insights are real time, within a single data repository
- eSource: Monitoring taken to the next level - sites capture the clinical data live as source thus avoiding transcription of source data into an eCRF. This approach removes the need for source document verification and potentially for source document review, depending on the trial’s needs. This strategy makes real-time data capture a reality.
More flexibility, more options
Cmed’s encapsia game-changing EDC and eSource platform can provide you and the sites with more and better options to ensure data are captured, managed, monitored and reviewed in the most efficient possible manner.