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Impact of ISO 14155 on PMCF Investigations Under the MDR
Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with...
Impact of COVID-19 and the Imminent MDR Delay
Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This...
Using Machine Learning to Identify At-Risk COVID-19 Patients (COVID-PREDICT)
The ongoing COVID-19 pandemic is one of the most serious health crises in modern history, affecting an unprecedented...
4 ways the Medical Device Regulation (MDR) will impact your device studies
Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As...
Mitigating the impact of COVID-19 on clinical research
Clinical trials are experiencing significant disruption worldwide due to the COVID-19 pandemic. Medical research is not immune to...
Forecasting the impact of COVID-19 on medical device trials
As of early April 2020, over 1,000,000 people have been confirmed infected with the SARS-CoV-2 coronavirus, and governments...
Castor launches COVID-19 monitoring and research platform, and is supporting over 100 trials globally
Platform to facilitate rapid deployment of trials to test vaccines and treatments Hoboken, New Jersey: April 2,...
ADVOR Study: 2019-20 Castor Research Award Nominee #11
Today’s increase in the incidence of heart failure is due to an aging population and therapeutic advances that...
Resources for clinical trials affected by COVID-19
Many are wondering how to start planning for COVID-19’s impact on clinical trials. Here are some resources that...
TEPHRA Study: 2019-20 Castor Research Award Nominee #10
High blood pressure affects at least 1 in 4 adults and is becoming more common in young adults....
JOINT Referral Study: 2019-20 Castor Research Award Nominee #9
Patients suffering from arthralgia at risk of an inflammatory rheumatic disease depend on an appropriate referral. But general...
FDA issues guidance for clinical trials during COVID-19 pandemic
On March 18, the FDA issued a guidance document for the medical research industry as a result of...
Coronavirus putting a halt on site-monitoring
Over the past few weeks, the entire world has been focused on the COVID-19 pandemic. With over two...
NARSYN Study: 2019-20 Castor Research Award Nominee #8
Respiratory syncytial virus (RSV) is the secondary cause of death after malaria for children <5 years of age...
DEXA-CORT Study: 2019-20 Castor Research Award Nominee #7
Dexamethasone is a synthetic glucocorticoid used by patients for immune-suppressive effects. But the drug can have severe side...
ProlaC Study: 2019-20 Castor Research Award Nominee #6
When treating microprolactinomas (hormone-secreting tumors on the pituitary gland) is surgical treatment (endoscopic adenoma resection) superior and cost-effective...
6 Steps for Using eCOA / ePRO & Physician Surveys to Fulfill MDR PMCF
To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance...
Coach2Move Study: 2019-20 Castor Research Award Nominee #5
Continuing the nominations for the 2020 Castor Research Award, here is nominee #5. The Coach2Move study looks at...
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