CDISC Application: The Global Standard for Faster Drug Approvals
Accelerating Drug Reviews with CDISC Compliance
Automating CDISC Standards to Streamline Submissions
[MediPanaNews = Reporter SungHoon Choi] Korean pharmaceuticals and biotech companies can no longer view global expansion as a option, it has become a necessity. However, the path from conducting clinical trial to securing regulatory approval remains challenging.
One of the biggest obstacles is that the domestic industry is still not fully aligned with international standards when it comes to processing clinical trial data, a fundamental step in new drug development.
In many countries, regulatory agencies require or recommend applying CDISC (Clinical Data Interchange Standard Consortium) from clinical trial stage.
CDISC refers to a standardized format for clinical and non-clinical study data submitted in drug applications. While the term originally referred to an organization that develops international clinical trial standards, it now broadly encompasses the standardization of clinical trial data.
JNPMEDI Executive Director, HyunSoo Lee emphasized the importance of CDISC adoption, stating, “For domestic companies to expand globally, CDISC is a must, and awareness of CDISC is steadily growing in Korea.”
For this reason, CDISC is a document designed for regulatory reviewers, and not for pharmaceutical companies or contract research organizations (CROs).
By defining standards for the electronic documentation of clinical trial data, CDISC facilitates the creation, exchange, submission, and storage of this information.
Since CDISC provides a standardized format, regulatory agencies can evaluate new drug applications based on structured reports alone, significantly streamlining the review process.
Recognizing these benefits, FDA has required CDISC-compliant clinical trial data submissions for electronic application (eCTD) since 2016. Japan and China have also made CDISC mandatory, while EU, although it’s not required, majority of applications are following CDISC standards.
Despite this global trend, Director HyunSoo Lee pointed out the reasons for delay in CDISC adoption in Korea: the limited number of professionals and the fact that domestic companies have not yet felt an urgent need for implementation.
Meaning that the importance of CDISC-based clinical data management is becoming more apparent, widespread adoption still remains a challenge.
Many companies question whether investing billions of won in compliance is necessary when Korea’s Ministry of Food and Drug Safety (MFDS) has yet to require it.
Lee, who previously led CDISC-based projects at Korea Otsuka Pharmaceutical and LSK Global PS, joined JNPMEDI in last September with the goal of promoting broader CDISC adoption in Korea.
JNPMEDI specializes in developing software solutions that systematically manages clinical trial.
Lee mentioned that the company is planning the launch of clinical trial data management program that automates CDISC standardization.
Beyond JNPMEDI’s Maven Clinical Cloud, Director Lee’s goal is to create a system that allows seamless compatibility between databases collected from various clinical trial software platforms, such as MEDIDATA and Cube, regardless of the system used.
She especially emphasized that the new program will ensure data quality that fully meets the CDISC standards required by global regulatory agencies.
Director HyunSoo Lee explained that "By utilizing the validation rules provided by CDISC, we can automatically perform checks after data conversion," adding, "This allows us to immediately verify if the generated data meets CDISC standards and regulatory agency requirements.”
She continued, “This will help prevent errors in advance and ensure quality. In other words, minimizing the time consumed during the data validation process and increases accuracy.”
She also predicted that once CDISC is established in Korea, the speed of new drug review could be further accelerated.
Currently, data standards vary for each sponsor, and the regulatory staff at the Ministry of Food and Drug Safety (MFDS) must track the reliability of the data for each individual submission, such as IND (Investigational New Drug) or NDA (New Drug Application) applications. This creates a gap in the process.
However, applying CDISC would mean that all companies submit data in the same format, which could significantly improve both time and reliability.
Lee emphasized, "The first goal is to create an environment in Korea where any company can easily apply CDISC." She also noted, "The MFDS has recently set a goal to strengthen its workforce and improve its systems for new drug approval reviews this year, and the atmosphere is gradually shifting toward creating a CDISC-compliant environment in Korea."
She concluded, "Rather than focusing on maximizing profits, our company’s goal is to shorten approval review times for customers through CDISC standard automation programs and help them succeed with regulatory agencies. From the customer’s perspective, this will clearly result in time and cost savings relative to resource investment."
✅ Original Article : https://www.medipana.com/article/view.php?news_idx=337176&sch_cate=D
[MediPanaNews = Reporter SungHoon Choi] Korean pharmaceuticals and biotech companies can no longer view global expansion as a option, it has become a necessity. However, the path from conducting clinical trial to securing regulatory approval remains challenging.
One of the biggest obstacles is that the domestic industry is still not fully aligned with international standards when it comes to processing clinical trial data, a fundamental step in new drug development.
In many countries, regulatory agencies require or recommend applying CDISC (Clinical Data Interchange Standard Consortium) from clinical trial stage.
CDISC refers to a standardized format for clinical and non-clinical study data submitted in drug applications. While the term originally referred to an organization that develops international clinical trial standards, it now broadly encompasses the standardization of clinical trial data.
JNPMEDI Executive Director, HyunSoo Lee emphasized the importance of CDISC adoption, stating, “For domestic companies to expand globally, CDISC is a must, and awareness of CDISC is steadily growing in Korea.”
For this reason, CDISC is a document designed for regulatory reviewers, and not for pharmaceutical companies or contract research organizations (CROs).
By defining standards for the electronic documentation of clinical trial data, CDISC facilitates the creation, exchange, submission, and storage of this information.
Since CDISC provides a standardized format, regulatory agencies can evaluate new drug applications based on structured reports alone, significantly streamlining the review process.
Recognizing these benefits, FDA has required CDISC-compliant clinical trial data submissions for electronic application (eCTD) since 2016. Japan and China have also made CDISC mandatory, while EU, although it’s not required, majority of applications are following CDISC standards.
Despite this global trend, Director HyunSoo Lee pointed out the reasons for delay in CDISC adoption in Korea: the limited number of professionals and the fact that domestic companies have not yet felt an urgent need for implementation.
Meaning that the importance of CDISC-based clinical data management is becoming more apparent, widespread adoption still remains a challenge.
Many companies question whether investing billions of won in compliance is necessary when Korea’s Ministry of Food and Drug Safety (MFDS) has yet to require it.
Lee, who previously led CDISC-based projects at Korea Otsuka Pharmaceutical and LSK Global PS, joined JNPMEDI in last September with the goal of promoting broader CDISC adoption in Korea.
JNPMEDI specializes in developing software solutions that systematically manages clinical trial.
Lee mentioned that the company is planning the launch of clinical trial data management program that automates CDISC standardization.
Beyond JNPMEDI’s Maven Clinical Cloud, Director Lee’s goal is to create a system that allows seamless compatibility between databases collected from various clinical trial software platforms, such as MEDIDATA and Cube, regardless of the system used.
She especially emphasized that the new program will ensure data quality that fully meets the CDISC standards required by global regulatory agencies.
Director HyunSoo Lee explained that "By utilizing the validation rules provided by CDISC, we can automatically perform checks after data conversion," adding, "This allows us to immediately verify if the generated data meets CDISC standards and regulatory agency requirements.”
She continued, “This will help prevent errors in advance and ensure quality. In other words, minimizing the time consumed during the data validation process and increases accuracy.”
She also predicted that once CDISC is established in Korea, the speed of new drug review could be further accelerated.
Currently, data standards vary for each sponsor, and the regulatory staff at the Ministry of Food and Drug Safety (MFDS) must track the reliability of the data for each individual submission, such as IND (Investigational New Drug) or NDA (New Drug Application) applications. This creates a gap in the process.
However, applying CDISC would mean that all companies submit data in the same format, which could significantly improve both time and reliability.
Lee emphasized, "The first goal is to create an environment in Korea where any company can easily apply CDISC." She also noted, "The MFDS has recently set a goal to strengthen its workforce and improve its systems for new drug approval reviews this year, and the atmosphere is gradually shifting toward creating a CDISC-compliant environment in Korea."
She concluded, "Rather than focusing on maximizing profits, our company’s goal is to shorten approval review times for customers through CDISC standard automation programs and help them succeed with regulatory agencies. From the customer’s perspective, this will clearly result in time and cost savings relative to resource investment."
✅ Original Article : https://www.medipana.com/article/view.php?news_idx=337176&sch_cate=D