As clinical development continues to become more complex and expensive the Pharma industry and Health Authority regulators have responded by matching different study monitoring models/ strategies to the perceived risks for study subjects. These models can be more efficient, produce better quality data and so reduce the cost of conducting clinical trials.
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. The models provided by Cmed range from a completely traditional approach (for example a monitoring visit every 4 to 6 weeks) through risk based monitoring, remote monitoring of image of source and an eSource approach (whereby sites capture the clinical data live as source thus avoiding transcription of source data into an eCRF).
Tailored to meet your needs
At Cmed, we develop our monitoring strategies by working with you to assess the many aspects of the study, the critical endpoints, the patients, the investigator sites etc. and determine and agree the optimal approach. We also recognize that clinical trials are dynamic and will review and agree any changes with you during the course of the trial.
- Traditional monitoring: Regular site visits performed that maximize monitor time spent at site.
- Risk-based monitoring: A strategy adopted in advance of study initiation reflecting the subject/ site type and complexity of the study that, in some situations, can reduce monitor time spent at site.
- Remote monitoring: A strategy that can increase site interaction allowing review of images of source data remotely (at Cmed this is facilitated by our technology), while also reducing expensive face-to-face time at site.
- Use of sophisticated data insights which can be actioned within our technology, encapsia®.
- eSource monitoring: Remote monitoring taken to the next level - sites capture the clinical data live as source thus avoiding transcription of source data into an eCRF. This strategy makes real-time data capture and analytics a reality.
More flexibility, more options
Cmed’s encapsia® clinical data suite 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.