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The Clinical Data Interchange Standards Consortium (CDISC) has become an essential standard in the global bio and pharmaceutical industries, and this shift is driving changes in Korea as well.

At JNPMEDI, we have analyzed these developments and compiled the latest domestic trends related to CDISC.

For two consecutive years, CDISC-related events have been held in Korea, and the CDISC headquarters recognizes these as significant opportunities. Domestically, the regulatory environment is also shifting toward stricter CDISC-based reviews, prompting companies to develop response strategies accordingly.

As CDISC is now a requirement rather than an option in global clinical trials, how should companies prepare? Let’s explore the key trends and the direction of these changes.

CDISC: A Key Requirement for Global Market Entry

CDISC plays a crucial role in standardizing clinical data, enhancing data quality, and meeting global regulatory requirements. At CDISC Interchange Seoul, held in August last year, the President of CDISC Headquarters attended in person to emphasize the necessity of CDISC in global clinical trials and share the organization’s future roadmap.

As the demand for CDISC implementation grows, related events are being actively held in Korea. The 2024 CDISC Day in Seoul was hosted in Korea for the second consecutive year, underscoring the increasing adoption of CDISC in the country. For companies aiming to expand into global markets, CDISC is no longer an option but a fundamental requirement.

Regulatory Changes Driving CDISC Adoption

CDISC adoption is no longer just an industry trend—it is becoming a regulatory requirement.

The Korean government is also showing clear signs of change. The Health and Welfare Committee recently requested a budget increase of KRW 1.553 billion to modernize the drug approval and review process, which includes building a CDISC-based clinical and non-clinical data review system and covering the licensing fees for programs such as Base SAS and JMP Clinical. This move reflects the regulatory agencies’ commitment to actively incorporating CDISC in their review processes.

These changes hold significant implications for domestic bio and pharmaceutical companies. As CDISC-based data management becomes a global prerequisite, Korean companies must prepare accordingly. Implementing structured and standardized data management will be a key factor in securing competitiveness in the global market.

How Korean Companies Are Responding—Strengthening CDISC-Based Data Management

As CDISC becomes the global standard, Korean companies are adjusting their strategies to align with this shift.

Domestic Contract Research Organizations (CROs) are also reinforcing their approaches to CDISC adoption. EPICORE recently stated that collaboration with CROs is the most effective way to facilitate CDISC submissions, proposing the use of data converters to manage internal data transformation processes.

Furthermore, data standardization is more than just a technical requirement—it enhances credibility in the global market and improves the efficiency of clinical trial operations. As a result, establishing strong CDISC-based data management capabilities will be a critical factor in securing competitiveness in future global clinical trials.

JNPMEDI Leading Innovation in CDISC-Based Global Clinical Data Management

Amid these changes, JNPMEDI is at the forefront of CDISC-based data management innovation, strengthening its role in supporting global clinical trials.

Through Maven Clinical Cloud, we provide standardized clinical data management solutions that comply with international regulatory requirements. As global clinical data regulations become increasingly stringent, JNPMEDI effectively supports data organization and submission based on CDISC standards, helping Korean bio companies streamline global clinical trial operations.

JNPMEDI goes beyond basic data management solutions by offering end-to-end clinical trial support, covering everything from trial design and data collection to standardization and submission. This ensures that companies can seamlessly meet global regulatory requirements.

CDISC Is no longer an option—It’s a requirement for global clinical trials

To keep pace with the evolving industry, structured data standardization is essential. Companies that act swiftly in adopting these standards will gain a competitive edge in the market.

In Korea, discussions surrounding CDISC adoption are gaining momentum, with both regulatory agencies and companies accelerating their preparations. At JNPMEDI, we are staying ahead of these developments and expanding our role as a leader in global clinical data standardization.

Clinical data management is shifting beyond simple record-keeping to a global-standard compliance model, and companies that effectively implement these standards will be well-positioned to stand out in the global market.

JNPMEDI remains committed to helping Korean companies successfully integrate CDISC-based data management systems, ensuring their seamless entry into the global clinical research landscape.

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📌 References

1. [데일리팜] 2024 CDISC DAY IN SEOUL 개최…최신 정보 공유 (2024.06.12)

2. [데일리팜] CDISC 인터체인지 서울, 글로벌 진출 필수 코스 (2024.08.19)

3. [메디파나] 복지위, 식약처 신약 허가·심사 혁신 예산↑… 지원 강화 기대 (2024.11.15)

4. [히트뉴스] CDISC는 데이터 과학(Data Science)의 길잡이다 (2025.01.14)

5. [네이버 블로그] 임상시험 데이터 정리, CDISC 없이 가능할까? (2025.02.16)