Risk Based Centralized Monitoring
Centralized Monitoring involves continuously reviewing all available electronic data for a clinical trial. The data is reviewed for
1. Data errors
2. Protocol Deviations
3. Trends & Patterns
Centralized Monitoring process when combined with Risk Analysis - Risk identification and Risk Mitigation can be implemented effectively, since Centralized Monitoring involves the review of overall clinical study data. The best part is that it can be implemeted anytime during a trial.
As per ICH GCP E6(R2): "The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s)." CRO Oversight is no more a recommendation but a requirement. Globally, all pharmaceutical companies (sponsors) are adapting to CRO Oversight as an effective way of keeping track of how their clinical trials are progressing. Get in touch with us if you would like to implement CRO Oversight in your clinical trial programs
Virtual Monitoring has been always the most efficient and cost-effective way of monitoring clinical trials. What was once a 'good-to-have' option, has become the need of the hour in the new normal.
Virtual Monitoring is only effective when implemented correctly. ClinTrek can help you leverage the technological advantages of virtual monitoring of your clinical trials.
This one tool can bring in significant improvement in the management of your trials.
As an organization, we believe strongly in our values –
ETHICS | INTEGRITY | QUALITY
in everything we do.
We also believe that the journey of conducting clinical trials is in itself an arduous trek and as a high-value service provider, we are here to ensure that our clients reach the zenith of success quickly and reliably!
ClinTrek Research Private Limited
17/159, Eeshavasyam, 4th Cross, Doresanipalya,
Bannerghatta Road, Bangalore - 560076
Call Us: +91 9845 055 425, +91 9866 951 573