Innovative Medical Device for Heart Failure Treatment Delivers Promising Results
Berlin Heals’ innovative implantable C-MIC device delivers encouraging clinical results in the treatment of heart failure.
1. June 2021
The global COVID-19 pandemic has largely impacted the healthcare system and also the conduct of clinical trials. Many sponsors have had to adapt clinical trial operations to the changing conditions of the pandemic, causing major disruptions in trial conduct. Some trials have had to face the shutdown of trial sites, limited access to regulatory bodies, or challenges in patient recruitment and engagement. SCIRENT has been working hard to ensure patient safety while keeping up trial continuity in all clinical trials.
Supporting sponsors to adapt to changing conditions
Our clinical trial and regulatory experts are constantly evaluating the changing conditions of the pandemic to ensure the safety and health of patients and employees. We monitor new regulations to ensure our operational business is aligned with government regulations and guidelines, and advise sponsors how to proceed with their on-going and planned trials.
Travel and social distancing limitations/restrictions may apply during the pandemic and thus it may be necessary to adapt trial designs to ensure continuity and compliance. Using telemedicine or home-based visits, SCIRENT keeps patients engaged in on-going studies and helps patients make up for missed visits at a later stage, when feasible. Wherever possible, we move trials to a remote or hybrid model to protect patients and to best meet their needs for in-home visits.
SCIRENT regulatory experts provide guidance on strategic and operational regulatory updates to support changing clinical trial operations during the pandemic. Clinical trials might need amendments, protocol and study modifications, or support for EC and IRB submissions. Our regulatory affairs staff can advise you how to proceed based on a risk assessment for your individual challenge.
Useful links:
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency (Revised). Guidance for Industry and Food and Drug Administration Staff. Food and Drug Administration. June 2020.
https://www.fda.gov/media/136290/download
Berlin Heals’ innovative implantable C-MIC device delivers encouraging clinical results in the treatment of heart failure.
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The global COVID-19 pandemic has largely impacted the healthcare system and also the conduct of clinical trials. Many sponsors have had to adapt clinical trial
