Pioneering cell therapies are changing the way that doctors and clinicians treat disease. Acepodia was founded in 2017 to focus on creating highly effective cell therapies that specifically target and engage cancer cells. The company’s researchers believe that by creating more potent cellular targeting mechanisms, Acepodia can create cell therapies that are both effective and accessible for patients with cancer.
Acepodia frequently collaborates with biopharmaceutical partners and academic institutes worldwide. In addition, contract research organizations (CROs) play an important role in the development of innovative therapies by supporting research and managing clinical trials. Contracts with CROs are highly regulated by the United States Food and Drug Administration (FDA) and other organizations. One of the FDA’s regulations, known as 21 CFR Part 11, establishes strict criteria for electronic records and electronic signatures, including controls around audits and validations.
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. Switching to digital workflows with electronic signatures would alleviate many of collaboration challenges, but any potential solutions needed to comply with 21 CFR Part 11.
“Adobe Acrobat Sign was the only electronic signature solution with built-in compliance for 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.”