Support for Virtual Clinical Trials from Cmed
Written by Crista Casey, VP of Clinical and Regulatory Operations
The dramatic coronavirus (COVID-19) pandemic has disrupted all aspects of daily life including clinical trials. Medical staff limitations and reorganizations, travel bans and access restrictions to medical facilities have challenged sponsors and sites’ current clinical trial processes.
The coronavirus outbreak has effectively forced a change in patient care and clinical trials. To continue bringing new therapies to market and support patients, sites and sponsors have accelerated the adoption of new technologies into decentralized trials or hybrid trials.
Cmed is well-placed to support sponsors with the change to a more decentralized approach.
First, we recognise that patient safety remains paramount.
Secondly, we have both processes and systems in place to manage mid-study protocol changes smoothly, staying true to the trial objectives.
Third, we have established offsite source document review, source data verification and central monitoring capabilities.
We have the advantage of a highly flexible clinical data system, encapsia, that enables any mix of clinical data collection methods into a single data repository, including EDC, lab data reports, wearables, eSource direct data capture (DDC) at trial sites or via nurse visit to patients’ homes.
Patient interactions are streamlined as sites can request drug dispensation, perform drug accountability, or randomize directly while using eSource or the Home Visit app for direct data entry. eSource reduces the number of site visits needed as there is no need for source data verification, and data is validated immediately on entry to limit post-visit queries.
Encapsia visualizes the clinical data and trial metadata in real time, enabling trial reviewers to quickly identify missing or anomalous data instead of wasting time moving data between systems in batches for analysis.
Encapsia is also straightforward to integrate with other systems using a RAID technology, enabling real-time data transfer and visibility, easy implementation and quicker setup. This can be adapted for ePRO, eCOA, televisit or wearable technologies to gather more data.
If you would like to talk to our team about our experience and capabilities in virtualized clinical trials, please contact in the first instance: