How can universities be sure they are remaining compliant during remote clinical trials?
Medical centers in top universities across the United States provide broad access to top-ranked specialized care, support clinical teaching programs, and develop new therapies. They are often seen as profit centers because of their ability to raise money through the endowments of the alumni.
Overall, there are 130 life sciences organizations sponsoring clinical trials at these universities. With access to graduate and undergraduate students and the population needed for testing, this is a tremendous source of revenue for the companies and the universities.
The universities also have a unique ability to attract new students and staff who are drawn there by a higher cause; they are intellectuals gaining a reputation based on the good research they are doing.
Now, dealing with a pandemic, universities need to have solid plans in place that support Food and Drug Administration (FDA) initiatives in order to grow this lucrative portion of their business. Just like life sciences companies are doing, universities must operate outside of their digital walls. System access and integration must happen in facilities and sites in real time. Now more than ever, clinical trials rely on the capabilities offered by the cloud. How can they be sure they are remaining compliant during remote clinical trials?
A large, California-based university already had DocuSign in place and they were kicking around the idea of a validated system. Then COVID-19 came along. Clinical trials with people coming on site for testing was no longer viable. Still, they needed to get approvals from doctors inside and outside the university and they needed to communicate with the companies funding these projects. Due to the complexities in medical research caused by the coronavirus pandemic, it became more relevant to have an eSignature solution that allowed them to work remotely and continue this process.
Shaping the Future of Remote Access for Clinical Trials
As universities take on higher-risk studies, scrutiny is on the rise by regulating authorities and the need for remote access will continue beyond the pandemic. Products and services like DocuSign and USDM’s Cloud Assurance are how these universities can ensure that they are meeting regulatory requirements and staying continuously compliant. Electronic signatures require greater validation of the process (i.e., signatures, transfer of data, storage of data) and data protection is of utmost importance.
USDM has helped universities validate DocuSign in a matter of days, not weeks or months, to enable compliant clinical trials. And with USDM’s Cloud Assurance subscription for DocuSign, these universities can trust that they remain in a validated state with every DocuSign cloud update as USDM manages the updates, patches, and vendor SaaS changes to minimize any compliance burdens.
Contact USDM to learn more about how your university can speed up its validation process and enable continuously compliant clinical trials.