How Adobe Acrobat Sign helps Acepodia comply with FDA regulations

Cancer affects millions of patients and their families every year. But innovative researchers around the world are making dramatic strides to create treatments that aim to fight cancers and improve health outcomes for patients worldwide.

Acepodia is one such innovator, focusing on developing powerful and accessible cell therapies. The key is Acepodia’s proprietary Antibody-Cell Conjugation (ACC) platform that helps immune cells bind more strongly to cancer cells and target tumors with greater precision.

Cancer research doesn’t take place in a vacuum. Acepodia collaborates with other research and academic organizations around the globe. Contract research organizations (CROs) also play an important role in the research pipeline by providing general support and running critical clinical trials.

Acepodia decided to digitize its agreements with these organizations to get them signed faster, even when signers live in different countries. But as a biopharmaceutical company, Acepodia needed to make sure that it’s digital documents and electronic signatures complied with regulations, including 21 CFR Part 11, part of the regulatory code for the United States Food and Drug Administration (FDA).

“Adobe Acrobat Sign was the only electronic signature solution that met our 21 CFR Part 11,” says Spike Lo, senior director business and corporate development at Acepodia. “By digitizing CRO agreements, we help research and clinical trials run smoother, which can lead to faster time to market for lifesaving and lifechanging treatments.”

Moving faster with electronic signatures

The clinical team at Acepodia typically used paper agreements to interact with CROs but processing wet signatures could be slow and expensive. While some employees work out of offices in the United States and Taiwan, many Acepodia employees work remotely, especially after the COVID-19 pandemic led to lockdowns in many regions. The company knew that switching to digital workflows with electronic signatures would alleviate many of collaboration challenges.

Adobe Acrobat Sign is 21 CFR Part 11 ready and includes the audit trails, identity verification, and other tools that help Acepodia meet its compliance requirements. As a result, the clinical team can switch out its slow, manual document workflows with electronic ones that boost speed and visibility. Acrobat Sign allows the clinical team to automatically route documents between signers, accelerating signing time. The clinical team can check the dashboard at any time to check the status of a routed document.

Signers can also use multiple methods to verify their identity, from phone authentication to single sign-on authentication. Acrobat Sign can be configured to help Acepodia capture the printed name of the signer, the time and date of the signature, and the reason for signing, as well as the signer’s email address and IP address. Additionally, Acrobat Sign uses strong encryption to keep documents secure throughout the signing process.

“With Adobe Acrobat Sign, we eliminate courier costs and reduce the time to complete a document from weeks to hours,” says Nathan Wong, associate operations manager at Acepodia. “Adobe Acrobat Sign gives us the features we need to meet strict healthcare regulations. By accelerating paperwork, we spend more time supporting critical research that brings hope to patients.”

Learn more about how Adobe Acrobat Sign is helping Acepodia operate more efficiently and meet their compliance requirements.