A message for our clients, investigator sites and industry partners
Written by David M Connelly, Chief Executive Officer, 06 Apr 2020
The global COVID-19 crisis has fundamentally impacted the way we live our lives as well as the operation of the entire drug development community. During the early stages of the pandemic the Cmed leadership team has implemented a number of measures to ensure the safety of our employees, clients and partners, as well as ensuring the continued delivery of our CRO services and our encapsia clinical data system. Our goal has been to minimise the impact of COVID-19 on our business, our clients, investigator sites and patients. For your information:
- Cmed staff are working remotely in all countries, with all systems working smoothly
- Our advanced clinical data system, encapsia, is already avoiding the need for CRAs to visit investigator sites through:
- Direct data capture eSource meaning no, or reduced, source data to review in the first place
- Web EDC and eSource used together flexibly within a trial or even a site
- Remote and risk-based monitoring processes
- Capture of source documents, screenshots etc in eSource DDC for remote review
- Cmed is also using its experience to
- access investigator site systems, where applicable, to enable remote source data review
- conduct study start-up activities remotely
- support or rescue ongoing studies that may be in difficulty, especially for example where data flow has become interrupted
- support Extended Access Programs through rapid database build and start-up, flexibility and ease of use
- Accelerate the release of the encapsia Home Visit app to support on and offline capture of clinical trial data from a patients’ home.
To sponsors leading the fight in the treatment of COVID-19
Cmed will provide encapsia and associated services for COVID-19 studies on a Not for Profit basis. This is a sincere and genuine offer.
Cmed management is fully committed to support the fight against COVID-19 and truly believes we can facilitate the capture and management of data for these types of studies more efficiently and quickly than other clinical data systems. COVID-19 studies need to be started rapidly, with high quality data from the outset, support CRAs who may not be able to visit the sites, as well as facilitate immediate decision making with immediate and real-time access to the study data 24x7.
Encapsia is purpose-built for modern, smart, clinical trials with fast database build, flexible data capture and loading options, plus live visualizations of aggregated data to deliver technical data science to our customers.
We expect there will be many more significant challenges ahead and we are committed to overcome them through resourceful, innovative and flexible approaches and thinking. We also want to express our continuing gratitude to our colleagues and friends in the industry. Despite these difficult times, which drive a bleak short-term outlook for the world, we are confident our industry of clinical research can provide the solutions for a brighter, better future.
With best wishes and good health on behalf of the Cmed Leadership Team
David M Connelly, Chief Executive Officer, Cmed Group