Trust is the cornerstone of all health and life science interactions, whether it’s following Good Clinical Practice in running clinical trials or in a patient-doctor relationship. The need for high trust carries throughout everything, including how documents and people are validated. I sat down with our CEO, Zack Schmidt, who shared his insights into why trust is important and how it is measured in Health Sciences.
What is the meaning of “High Trust” in Health Sciences?
High trust is an electronic signature based on cryptographic methods to authenticate both the identity of the signer and the integrity of the document signed. In clinical research, the FDA defines these requirements as part of 21 CFR Part 11 and in FDA SOP 8116.
At a high level, think of the trifecta of trust as being document integrity + identity validation, all validated to be 21 CFR Part 11 compliant.
What’s the difference between commercial electronic signing and high trust digital signing?
We sign electronically all the time in our daily lives – when we sign for groceries on a touchpad with our credit card, or even with real estate transactions or contracts. Those solutions are convenient and easy to use. If there is any kind of identity validation at all, it is usually only your email address. However, electronic signatures in Healthcare must pass a much higher level of validation to meet 21 CFR Part 11 requirements. So, while those solutions are convenient, commercial signing doesn’t meet the infrastructure and processes required in Health Sciences.
Why is high trust signing important for Health Sciences?
All of us involved in clinical trials have a similar goal: to get lifesaving drugs and devices to patients sooner. To help meet that goal, starting in 2017, the FDA has asked for all submissions for forms such as FDA Form 1572 be completed, signed and submitted digitally to streamline the drug evaluation process. While it is still technically possible to submit the many thousands of documents manually, (mostly) gone are the days when truckloads of documents are delivered to the FDA. So, since there are so many electronic documents coming in, you can rest assured that the FDA has some standards you need to meet when submitting them.
High trust digital signing is important not only because it will pass the scrutiny of an audit, but it is also up to 90% more efficient than wet signatures. With the average study having over 3000 documents that need to be validated and signed, the efficiency benefits expand tremendously – all while meeting the rigorous FDA and EC standards.
How can I do this without starting over?
We have many customers who start their digital journey leveraging our cloud-based SurePlatform for our SureESign digital signature solution, but also to manage contacts and collaborate with project team members. In fact, one of our customers just published a case study where they were able to use SurePlatform to get a 100 site study started in less than 3 months.
Many of our customers that are looking to replace their non-compliant existing signing start by adopting our enterprise collaboration platform before they’re ready for a fully unified clinical trial management system, or perhaps they have a legacy system they need to keep working with. The platform is the foundation of our own suite of unified apps and on its own provides enterprise collaboration and connectivity to other legacy systems. And, it’s a cloud-based solution that we typically can get it up and running in minutes, not months.
How can I learn more?
We’re happy to talk to Health Science professionals looking
to ensure they have a fully compliant signing solution. Simply contact us and we’ll set up a demo. We also have a few events coming up where will we demo SureESign publicly.
Webinar: Best Practices for Study Startup: Leveraging Digital Signatures and Process Automation
If you’ll be at HIMSS, stop by and see us at booth 8200-49 in the “Innovation Live” area.
Our product teams have spent decades working on clinical
trials and have deep domain expertise in regulatory and technology issues
specific for the Health Sciences market.
SureESign, like all SureClinical cloud applications, was built by and for Health Science professionals from the ground up to support the stringent regulatory
requirements for healthcare and life sciences.
We’re so confident in our adherence to FDA and EC requirements, we even
have our processes and software independently audited.
About the Author
Laurie Pattison has spent her career working at the intersection of people and technology. By day, you can find her responsible for Marketing for SureClinical. On weekends, you’ll find her snowshoeing or hiking with her dogs in the beautiful Sierra Nevada mountains we’re lucky to have in SureClinical’s backyard. Connect with Laurie on LinkedIn.