Acepodia digitizes paperwork and signatures while maintaining compliance with Adobe Acrobat Sign.
Achieve compliance with FDA code 21 CFR Part 11
Comply with industry and government regulations
Streamline paperwork between remote employees in a multinational company
Communicate more efficiently with partners for stronger research and clinical trial support
Achieve compliance with FDA regulations with built-in processes
Accelerate signing time with documents returned weeks faster
Eliminate courier fees to route documents between signers
Maintain more secure audit trails required in healthcare
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.”
Senior Director Business and Corporate Development, Acepodia
Adobe Acrobat Sign includes the audit trails, identify verification, and other tools that help Acepodia make its electronic signatures 21 CFR Part 11 compliant. Signers can use multiple methods of verifying their identify, from phone authentication to single sign-on authentication. Using the Bio-Pharma Settings, Acrobat Sign can capture the printed name of the signer, the time and date of the signature, and the reason for signing—all information required by 21 CFR Part 11.
In addition, Acrobat Sign records the name, email address, and IP address of the signer along with the date and time of the signing for its audit trail. The audit trails are collected into an audit report for each document, further supporting 21 CFR Part 11 compliance. Strong encryption keeps documents highly secure at every step of the signing process, from the time documents are first sent out by Acepodia staff until they are finalized and stored in Acrobat Sign.
“The 21 CFR Part 11 validation process was critical for electronic signatures to work for us,” says Lo. “Adobe Acrobat Sign helps us move away from paper while maintaining the compliance that we need. It is reassuring to know that if we’re ever audited by the FDA, we can demonstrate compliance.”
Associate Operations Manager, Acepodia
The eight members of the clinical team frequently send documents and agreements to CROs. These documents require multiple layers of approvals with audit trails and identity verification every step of the way.
With Adobe Acrobat Sign, Acepodia can automatically route documents to any number of signers. This speeds up signing time by eliminating delays between signers. Before, signers needed to return documents to the clinical team or remember to forward documents to the correct person in the approval chain. Signers sometimes handed off signed documents to a courier, which was costly and slow. Otherwise, they would fax or email the scanned document, which tended to lower document quality and create multiple copies of each document.
“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. “Acrobat Sign gives us much more visibility throughout the signing process so that we know exactly who has received the document and whether it’s been signed.”
Associate Operations Manager, Acepodia
While Acepodia initially chose Adobe Acrobat Sign for its 21 CFR Part 11 compliance, the company is starting to explore using Acrobat Sign for other types of electronic signatures across the company. Human resources, legal, and general business documentation could all benefit from the speed of digitization.
“All companies are going paperless and implementing electronic signatures because it’s a much faster and more efficient way of handling paperwork—especially with a multinational workforce,” says Wong. “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.”