Speed, Savings And Security: Leveraging The Power Of E-Signatures In Clinical Trials
By Pem Guerry, Executive Vice President, SIGNiX
The devil is in the documentation. At least, so it seems with clinical trials. Every step, decision and result of each trial phase must be inked, approved, filed and submitted to appropriate parties. Because trials are part of drug and therapy development, keeping detailed records is a must. But the sheer amount of paper-pushing can dramatically slow the pace of a clinical trial.
Fortunately, technology is simplifying this documentation, particularly with the expansion of electronic signatures.
Today, most e-signature platforms are built within cloud-based infrastructures. Documents are hosted online and can be accessed by authorized people anywhere there’s an Internet connection, on any device. This ubiquitous and immediate access to approve documents is especially valuable for clinical research organizations needing to ease the paper burden. Rather than printing, stamping and shipping documents for a physician’s or a patient’s signature (a process that can take many days, if not a few weeks), documents can be signed the moment they are ready.
The Bottom-Line Impact of E-Signatures
E-signature usage is on the rise—having grown at a rate of 53 percent annually since 2012, according to Forrester—and clinical research organizations are among the many starting to leverage its power.
In fact, one of the world’s leading clinical research organizations recently adopted e-signatures to meet the challenge of rising clinical trial costs and ever-burdening paperwork. The organization piloted its e-signature program to expedite the physician signature process. Running approximately 500 clinical trials a year with more than 1,000 physicians dispersed across the world, the organization found that adopting e-signatures for trial approvals resulted in a dramatic improvement: e-signatures reduced the average time to sign clinical trial documents from up to 58 days to just three to four days. It also saved approximately $250,000 in paper-related costs during the first year of implementation.
From a big-picture perspective, here’s what e-signatures can mean for clinical trials:
- Drugs get to market faster. This means healthier patients and a healthier pharmaceutical industry. A company can lose revenue of more than $2.7 million each day a blockbuster drug is delayed in getting to market, according to a report by Ronald D. Snee of Tunnell Consulting.
- Clinical research organizations are paid sooner. E-signatures expedite document workflows. That means trials can start on time and organizations are compensated quickly, improving the fiscal balance.
- Time and money can be reallocated to focus on mission-critical tasks. Something as simple as revamping signature processes can free a significant amount of labor and money that can be allocated to other areas of the trial or organization. Employees no longer have to spend time sorting documents and tracking down signatures, and companies no longer have to pay for paper, ink, shipping and storage for documents.
- Security is improved. When using e-signatures that deploy identity authentication, encryption, audit trails and other security technologies, documents become more secure than those signed by wet ink and paper.
Types of E-Signatures for Clinical Trials
Before e-signatures can benefit clinical trials, they must first meet regulatory and security requirements. Many different kinds of e-signature platforms exist, so it’s important for clinical trial administrators to examine the e-signature solution’s technical architecture before moving forward with adoption. Here’s what to look for:
Independence. An e-signature can be a simple electronic image symbolically representing a signature, or it can be a more complex digital process. But all e-signatures can be divided into two camps: independent and dependent.
Independent e-signatures (also called digital signatures) directly and permanently embed an e-signature’s cryptographic information (or legal evidence) into the signed document. An independent e-signature uses public key infrastructure—a process that incorporates a public key anyone can access and a private key stored in a secure location—to ensure the signature is unique to the person using it, the validity of the signature is undeniable and the document retains integrity. All parties always have direct access to the legal evidence of a signature.
Digital documents signed with independent e-signatures don’t have to remain on outside severs, which provides more document control. Copies can be digitally destroyed from a vendor’s servers so that there is only one point-of-access to the documents.
Alternatively, dependent e-signature technology simply links an image of a signature back to a vendor’s server. The server is where legal evidence is stored, meaning users must rely on their relationship to a vendor to verify a signature’s validity.
Compliance. Most e-signatures used in the United States are compliant with the federal Electronic Signatures in Global and National Commerce Act (ESIGN) and the state level Uniform Electronic Transactions Act (UETA), which provide the framework for legally acceptable e-signatures in the U.S. But e-signatures used for clinical trials must also be compliant with 21 CFR Part 11 regulations outlined by the U.S. Food and Drug Administration (FDA). Otherwise, the FDA will not accept trial documents or signatures in electronic form.
21 CFR Part 11 necessitates heightened security measures that aren’t required by ESIGN or UETA. These measures include detailed audit trails that track every part of the signing process, tamper-evidence technology to alert users of document changes and multi-factor authentication, which deploys at least two levels of identity-authentication technology.
Adherence to Standards. The technology that undergirds e-signature software should be based on international, published standards for two primary reasons:
- Published standards exist in the public domain, which means they will always be discoverable, even if they fall into disuse.
- If clinical trial documents are submitted to organizations outside of the United States, e-signatures backed by international standards are more likely to be accepted worldwide than those based on proprietary technology.
Technology can help save significant time and money, and e-signatures are a prime example of this, especially within in the clinical trial space. That means documentation won’t hold the devilish distinction that it could. And clinical trial administrators can focus less on the administration and more on the trials.