The rise of coronavirus continues, with more than 13 million confirmed COVID-19 reported cases. Into this dynamic landscape, pharmaceutical companies, large and small, have sped forward to develop potential treatments and interventions. Currently, there are over 1,900 clinical trials in progress around the globe – ranging from examining the safety and effectiveness of vaccines to the treatment of managing coronavirus symptoms.
Companies interested in running COVID-19 studies need to be up to the challenge, and then some! These types of trials are conducted differently than standard drug or device trials and require a strategy that includes a laser-focused mindset along with the guidance of partners experienced in the ever-changing landscape of COVID-19 trials.
Biorasi is Ready for Action! Are You Prepared for Your COVID-19 Trial?
Biorasi is a full-service global CRO, experienced and engaged in the management of multiple coronavirus clinical trials. For companies ready to start up and initiate on potential opportunities to develop interventions and treatments for COVID-19, we are ready for action.
Over the next few weeks, Biorasi will be posting detailed articles on the dynamic and demanding landscape for COVID-19 trials, and what pharmaceutical companies and CRO partners need to be prepared for. This includes:
- Disease Management. Looking for epidemiological certainty in your clinical trial? You won’t find it in COVID-19 studies. You need to be prepared to address an ever-changing virus that features variable symptoms across diverse demographics and geographies. You need to be able to react quickly to any and all changes and update trial protocols and study documents if necessary.
- Site Selection. Be prepared to throw your current site selection process out the window. Patient safety in COVID-19 studies is paramount during clinical trials, and this includes how you communicate with clinical sites – and how you set up remote solutions – to ensure regulations and good clinical practice (GCP) guidelines are being met.
- Regulatory Timelines. Speed is the key in COVID-19 studies. Remember: fast-tracking vaccines and treatments is imperative; running these studies in the wake of multiple approved drugs on the market will be more difficult. Thankfully, regulators are recognizing expedited timelines and offering review (s) in days or weeks – not months. To stay agile and able to make quick decisions, you need a proactive strategy that features risk mitigation and robust collaboration with your CRO and clinical sites.
- Monitoring Solutions. Traditional clinical trial practices may not be able to address the ever-changing landscape for COVID-19 variables. Strongly consider decentralized remote monitoring solutions – including site selection, initiation, and close-out visits; Remote Source Data Verification (SDV); mobile device data capture; and 24/7 real-time data transparency. A decentralized strategy is your toolbox of choice for COVID-19 clinical trial challenges.
- Patient Scheduling. What else is in the decentralized strategy toolbox? Remote patient solutions, of course. Remember: Your target patient population is compromised from the coronavirus. Meeting milestones for COVID-19 trials is “virtually” impossible without remote options – from telemedicine and home nursing care to mobile devices and eSourcing.
If you are considering a COVID-19 study, Biorasi encourages you to think carefully about the challenges you’ll encounter and the need for an agile response. Stay tuned for our upcoming posts and start preparing now.
If you are ready to move forward, schedule a call with one of our experts to talk about your upcoming COVID-19 clinical trial.