#Nucleus #Network #streamlines #clinical #trial #management #Adobe #Acrobat #Sign
When the COVID-19 pandemic swept across the world, the healthcare industry had to quickly rethink how it worked. Within months, clinical trials began to test the efficacy of COVID-19 vaccines and treatments. The fast response helped bring medicines to people faster, helping to reduce the spread and threat to life caused by COVID-19.
In this article
- Achieving FDA compliance with Acrobat Sign
- Streamlining clinical documents
- Electronic signatures for all use cases
Many of these clinical trials were managed by clinical research organizations (CROs) that specialize in running clinical trials for biotechnology and pharmaceutical companies. Nucleus Network, a multinational CRO operating out of Australia and the United States, applies its expertise to a wide range of clinical trials studying everything from COVID-19 to asthma to ALS. By helping clinical trials run smoothly, Nucleus Network can help accelerate the time to market for life-changing and lifesaving treatments.
One of the most time-consuming parts of managing any clinical trial is paperwork. “Clinical trials are highly regulated,” explains Vijay Shetty, Head of Information Technology for Nucleus Network. “We need to demonstrate that we run our clinical trials according to strict guidelines that meet all scientific and ethical standards. This means we have to carefully document everything we do.”
Nucleus Network was already well on its way to digitizing signature processes before the COVID-19 pandemic made touchless processes a necessity. While many trials are run out of Australia, the company needs to comply with various regulations in countries where it submits its filings. For example, Nucleus Network needs to comply with 21 CFR Part 11, which is part of the regulatory code for the United States Food and Drug Administration (FDA). It establishes requirements for how organizations must handle electronic documentation and electronic signatures in a clinical setting.
“I spent a lot of time going through the regulations and researching possible solutions,” says Shetty. “Adobe Acrobat Sign had the answer we needed to help us streamline paperwork and handle clinical trials more efficiently.”
Achieving FDA compliance with Acrobat Sign
Many departments at Nucleus Network were already using Adobe solutions, such as Adobe Creative Cloud and Adobe Acrobat. When Shetty discovered that Adobe Acrobat Sign could be leveraged for regulated use cases, Acrobat Sign was validated to make sure it met the company’s requirements and approved by the quality team for use in production by clinical teams.
Two of the biggest compliance challenges that Acrobat Sign solves are signature manifestations and signature authentication. For 21 CFR Part 11 compliance, each signature must have a signature manifestation that includes the reason for the signature, and Acrobat Sign allow Nucleus Network to add this reason field for signers.
Acrobat Sign also enhances signer identification by adding an option for signers to identify themselves with phone authentication. “To comply with 21 CFR Part 11, we need to tie signers to a unique identifier in addition to their email address,” explains Shetty. “Internally we can use the Adobe Acrobat Sign login, but we need something else for external signers. That’s where phone authentication comes in. We send a unique identity verification code to signers’ phones, which helps us achieve compliance.”
Streamlining clinical documents
Working with Acrobat Sign, Nucleus Network has digitized clinical documentation for electronic signatures. The project management team are especially heavy users of Acrobat Sign. Nucleus Network may run around 50 clinical trials simultaneously, and it’s the project management team’s job to keep on top of validation protocols, user requirements, and training for clinical staff. All these documents can now be signed electronically while maintaining critical audit and compliance standards. Acrobat Sign also benefits clinical documentation with greater speed, group signing, and lower costs.
“One company executive told me that he was signing a document on his phone on the way to the airport — he was very impressed by how easily we could get things signed and how that can help us run clinical trials more efficiently.”
Greater speed: With people working out of clinical trial sites in Brisbane and Melbourne in Australia and Minneapolis, Minnesota in the United States, even getting a simple document signed by more than one person could easily take a week or more. With Acrobat Sign, it now takes minutes. “One company executive told me that he was signing a document on his phone on the way to the airport,” says Shetty. “He was very impressed by how easily we could get things signed and how that can help us run clinical trials more efficiently.”
Bulk signing: Nucleus Network uses internal training records for bulk signing. Internal training records are used to capture appropriate training for individual study protocols. This is managed by the project management team.
Lower costs: Clinical documentation can get quite detailed and long. By digitizing documents, Nucleus Network eliminates print and postage costs, saving money while saving the environment.
Electronic signatures for all use cases
While Nucleus Network decided to standardize on Acrobat Sign for its compliance support, it’s useful across many areas of the organization, including:
- Change control documents
- Contracts with sponsors
- Validation documents
- NDA with vendors
- Internal training records
- File notes
- Employee contracts
Currently around 2,500 documents per month are sent through Acrobat Sign. Shetty expects that number to increase even further with potential Microsoft SharePoint and Salesforce integrations on the horizon.
“Adobe Acrobat Sign is great for everyone,” says Shetty. “It saves time, it’s very easy, and it keeps things compliant. It’s a win for us, for our sponsors, and ultimately for volunteers who participate in our clinical trial.”
Learn more about working with Adobe Acrobat Sign in the Healthcare and Life Sciences industry.