2 September, 2020, by clincapture-client
Over the past several months, clinical trials have moved at a rapid pace to find viable treatments for COVID-19. The Food and Drug Administration (FDA) created an emergency program that “uses every available method to move new treatments to patients as quickly as possible.” As of July 31, more than 570 drug development programs were in planning stages, more than 270 trials were reviewed by the FDA, and two treatments have been authorized for emergency use. For decades, most drugs endured a number of tests before regulators such as the FDA allowed it to be released to the mass market, leaving a small percentage that was fast-tracked for use. Seeing trials accelerate, it leaves many wondering if it is the new normal.
COVID-19 has facilitated the adoption of early technology, explained ClinCapture CEO Scott Weidley. This has occurred across multiple industries. For example, tools for remote meetings are not new, however during the COVID-19 pandemic, as many employees were no longer able to work from their offices, they had to quickly adapt to the existing technology. Such is the case with Electronic Data Capture (EDC), the core technology is not new, however, it is being adopted faster. “As regulatory bottlenecks are widening” with the help of guidance from the FDA, Weidley said, “study build times increasingly become a limiting factor.” He added, “now it is more important than ever to select the fastest EDC partner available.”
Due to COVID-19, current studies that continued or were related to the pandemic underwent protocol amendments for remote/virtual trials introducing remote site monitoring and remote work. With the use of EDC, it is easy to amend protocol changes with eCRFs, also known as electronic Case Report Forms. Changes completed in intuitive systems like ClinCapture are simple and easy to do. But an EDC helps accelerate the trial even further.
With remote/virtual trials gaining more prominence, and the convenience of an EDC, remote site monitoring, data verification and reporting are seamless. Advanced reporting through ClinCapture’s Captivate EDC is conducted in real-time with the information readily available for data managers, CRO’s and/or sponsors. Electronic Patient Reported Outcomes (ePRO) and electronic Clinical Outcomes Assessment (eCOA), allows patients, clinicians and caregivers to report data electronically through a phone, computer or tablet anywhere.
What does the future of trials look like? Weidley believes that the number of clinical trials recorded purely on paper will be nearly eliminated in 5 to 10 years, as EDC achieves total adoption. Ultimately, studies will no longer need a paper source at all, as electronic source documents, or eSource offers a way to comply with the FDA.
ClinCapture announces Captivate 3.4ClinCapture is excited to announce Captivate 3.4 with new features that improve your experience. We’ve enhanced the system and added additional tools. Here is a breakdown of the changes: Build New VAS Scale Printable annotated case report forms (CRFs) Customizable date/time format Ability for users to fully build and configure patient surveys themselves within ePRO
1 September, 2020
Meet the Team: Scott WeidleyIn San Francisco, as office spaces remain closed, workers are busy keeping up with day-to-day business out of their homes. That includes ClinCapture CEO Scott Weidley. Sitting in his home office surrounded by vintage guitars, Weidley checks-in with employees through video calls and emails. “I am very proud of what the team has accomplished while working remotely, but I am excited for the day
16 March, 2020
Clinical Research for COVID-19With the pandemic of COVID-19, efforts to speed up treatments and develop a vaccine are increasing dramatically. Many companies have been repurposing antivirals while others are pursuing a more high-tech approach. With recent findings from Clover Biopharmaceuticals, COVID-19 is variegated with a protein aptly called ‘Spike’ (S) protein, allowing the virus to burrow into the cells of humans, ma