Establishes a Smart Clinical Trial Environment by Digitizing the Entire Clinical Trial Contract Process, Advancing ESG Management Practices

Chief Director Joon Woo Bahn of Clinical Trial Center at Asan Medical Center said,

"By shortening the contract process, we will improve patient access to new drugs and strengthen our research competitiveness."

▲ Chief Director Joon Woo Bahn of the Clinical Trial Center at Asan Medical Center (far left) reviews electronically signed clinical trial agreements with researchers.

The Clinical Trial Center at Asan Medical Center has embarked on the digital transformation of research administration by introducing an electronic signature system for clinical trial agreements with global pharmaceutical companies. The initiative aims to enhance research competitiveness and accelerate study initiation in response to changes in the global clinical trial environment.

Recently, the Clinical Trial Center signed clinical trial agreements using the electronic signature system with global biopharmaceutical companies, including Gilead Sciences, Roche, and GSK. This marks the first case in Korea's hospital sector in which a hospital president's electronic signature has been applied to clinical trial agreements between medical institutions and pharmaceutical companies.

Currently, 14 of the world's top 15 pharmaceutical companies utilize electronic signature systems, while leading overseas medical institutions have also actively adopted electronic signatures for research agreements. In recent years, demand for electronic signatures to expedite contract execution has steadily increased not only among global pharmaceutical companies and international research institutions, but also among hospital investigators.

Previously, clinical trial agreements between medical institutions and pharmaceutical companies required multiple administrative procedures, including signatures from pharmaceutical companies and investigators, internal approvals, affixing the hospital president's seal, scanning and storing original documents, and sending contracts by mail. These processes also resulted in considerable postal expenses and administrative burdens associated with document storage.

By shortening the contract execution period, the Clinical Trial Center will be able to accelerate the initiation of clinical studies, enhance its research competitiveness, and expand opportunities to participate in innovative drug development research.

In addition, reducing the need for printing contracts, storing original documents, and sending materials by mail is expected to improve administrative efficiency while supporting the Asan Medical Center's ESG management initiatives.

Asan Medical Center signs more than 1,000 sponsor initiated clinical trial agreements each year. Given that even printing just two copies of each agreement under the conventional system generates thousands of pages of paper documents annually, the introduction of electronic signatures is expected to deliver significant cost savings and environmental benefits.

In addition, the electronic signature system adopted by the Clinical Trial Center provides identity verification through signer email authentication and offers an audit trail function that automatically records signing times, IP addresses, and authentication histories.

As every step of the contract process is digitally documented and protected against tampering, the system further strengthens document integrity and security. Under Korea's Electronic Signature Act, electronic signatures carry the same legal validity as handwritten signatures when mutual agreement between the parties and anti tampering technologies are secured.

Chief Director Joon Woo Bahn of Clinical Trial Center at Asan Medical Center, said, "The adoption of electronic signature agreements marks an important turning point that goes beyond simply replacing paper contracts with digital documents. It represents a significant innovation in aligning our clinical trial operating system with global standards."

He added, "Moving forward, we will accelerate the digital transformation not only of the contract process but also of the entire clinical research ecosystem. By providing sponsors with a faster and more efficient research environment and expanding patients' access to innovative new therapies, we aim to lead the global standard for smart clinical trials."

Established in 2002, the Clinical Trial Center at Asan Medical Center has led the advancement of clinical research in Korea over the past two decades, building world class clinical trial capabilities based on outstanding research infrastructure and specialized expertise.

In particular, the center established the Academic Research Office (ARO) in 2013 to systematically support investigator initiated clinical trials, enabling researchers to identify unmet medical questions and generate clinical evidence on their own.

In 2020, it also launched the Clinical Trial Strategy Development Office to strengthen collaboration with domestic and global pharmaceutical companies as well as contract research organizations (CROs). Moving forward, the center plans to further enhance its global competitiveness in clinical research by advancing its digital research environment and continuously strengthening its research support system.