Song Hyun YANG, Ph.D CEORecognizing the need for a specialized lab to provide tailored services for the increasingly complex demands of clinical trial sample analysis, South Korea-based Global Clinical Central Lab (GCCL) was established in 2019 as a joint venture between GC Cell, a company that develops cell therapy products and operates a CDMO business and C&R Research, a South Korea-based global CRO company.
By blending the local expertise of a regional lab with the capabilities of a global giant, GCCL's vision extends far beyond its domestic boundaries, rewriting the script of clinical trial support. It caters to new drug development companies such as bioventures, pharmaceutical companies, CRO companies, and hospitals.
What sets GCCL apart is its unique combination of central lab and bio-analytical functions. While many other central labs in Korea outsource their bio-analytical analysis, GCCL provides customized analysis services for all clinical trial phases, from Phase 1 to 4. It possesses expertise in PK/ PD, biomarker analysis, ADA, neutralizing antibody analysis, method development, and validation for small molecule drugs and biologics. This holistic, multifaceted approach positions GCCL as a one-stop shop for sponsors seeking comprehensive support throughout trials.
Strengthening its bio-analytical services, the company has also increased its involvement in early-phase clinical trials of new drugs developed by pharmaceutical and biotech companies. With specialized Biosafety Level 3 facilities, GCCL also handles numerous projects on developing vaccines and therapeutics for infectious diseases. Approximately 30 percent of the COVID-related projects conducted in South Korea have been collaboratively undertaken with GCCL. Additionally, GCCL have recently been preparing for the future by strengthening clinical trial sample analysis for CNS diseases including dementia.
The company operates in alignment with international guidelines such as the FDA and EMEA and aims to establish itself as a prominent central lab in Asia. To achieve this, GCCL has partnered with over 15 harmonization labs worldwide, increasing its involvement in global projects. It also plans to expand through overseas-owned labs and offices, promising a greater global reach and impact.
"In addition to our analysis services, we take immense pride in our project management prowess. We have embraced cutting-edge technology, implementing Thermo Fisher's LIMS to streamline analysis management. We have also developed our in-house system, G-HUB, which provides a customer portal for real-time project monitoring," says Song Hyun YANG, Ph.D, CEO of GCCL. "Combined with our meticulous lab-collection kit production and a nationwide logistics network, we ensure clients full visibility and transparency into the progress of their projects, from sample collection to final analysis."
Combined with our meticulous lab-collection kit production and a nationwide logistics network, we ensure clients full visibility and transparency into the progress of their projects, from sample collection to final analysis
The company operates in alignment with international guidelines such as the FDA and EMEA and aims to establish itself as a prominent central lab in Asia. To achieve this, GCCL has partnered with over 15 harmonization labs worldwide, increasing its involvement in global projects. It also plans to expand through overseas-owned labs and offices, promising a greater global reach and impact.
GCCL offers various proposals and tailored solutions to sponsors in multinational clinical trials. In a Phase 3 clinical trial across Korea, Asia, and Europe, GCCL played a pivotal role in cost reduction and efficiency optimization. By collaborating with a harmonization lab in Europe, GCCL reduced transportation costs by approximately USD 3 billion and reduced turnaround times by 2-3 days. This costeffective solution highlights GCCL's commitment to delivering value to clients.
In another project involving sample processing across Asian countries, GCCL coordinated rapid sample processing and transportation to a specialized lab in Europe. This intervention successfully included Asian sites in the global project, demonstrating GCCL's adaptability and dedication to solving complex logistical challenges.
Through innovative solutions and a commitment to excellence, GCCL offers tailored solutions that elevate the quality and efficiency of clinical trials. As it expands its global footprint, GCCL is set to leave an indelible mark on the field, shaping the way clinical trials are conducted worldwide.
[PR] Elevating Clinical Trial Services to New Heights
Monday, December 11, 2023
South Korea's ascent to becoming one of Asia's top clinical trial sites has been nothing short of remarkable, with
Seoul consistently ranking within the top 5 world clinical trials by city annually. However, in the past, clinical trial samples from Korea often detoured to countries like Singapore, which have major central labs.
Recognizing the need for a specialized lab to provide tailored services for the increasingly complex demands of clinical trial sample analysis, South Korea-based Global Clinical Central Lab (GCCL) was established in 2019 as a joint venture between GC Cell and C&R Research.
By blending the local expertise of a regional lab with the capabilities of a global giant, GCCL's vision extends far beyond its domestic boundaries, rewriting the script of clinical trial support. It caters to new drug development companies such as bioventures, pharmaceutical companies, CRO companies, and hospitals.
What sets GCCL apart is its unique combination of central lab and bio-analytical functions. While many other central labs in Korea outsource their bio-analytical analysis, GCCL provides customized analysis services for all clinical trial phases, from Phase 1 to 4. It possesses expertise in PK/PD, biomarker analysis, ADA, neutralizing antibody analysis, method development, and validation for small molecule drugs and biologics. This holistic, multifaceted approach positions GCCL as a one-stop shop for sponsors seeking comprehensive support throughout trials.
Strengthening its bio-analytical services, the company has also increased its involvement in early-phase clinical trials of new drugs developed by pharmaceutical and biotech companies. With specialized Biosafety Level 3 facilities, GCCL also handles numerous projects on developing vaccines and therapeutics for infectious diseases. Approximately 30 percent of the COVID-related projects conducted in South Korea have been collaboratively undertaken with GCCL.
"In addition to our analysis services, we take immense pride in our project management prowess. We have embraced cutting-edge technology, implementing Thermo Fisher's LIMS to streamline analysis management. We have also developed our in-house system, G-HUB, which provides a customer portal for real-time project monitoring," says Song Hyun YANG, CEO of GCCL. "Combined with our meticulous lab-collection kit production and a nationwide logistics network, we ensure clients full visibility and transparency into the progress of their projects, from sample collection to final analysis."
The company operates in alignment with international guidelines such as the FDA and EMEA and aims to establish itself as a prominent central lab in Asia. To achieve this, GCCL has partnered with over 15 harmonization labs worldwide, increasing its involvement in global projects. It also plans to expand through overseas-owned labs and offices, promising a greater global reach and impact.
GCCL offers various proposals and tailored solutions to sponsors in multinational clinical trials. In a Phase 3 clinical trial across Korea, Asia, and Europe, GCCL played a pivotal role in cost reduction and efficiency optimization. By collaborating with a harmonization lab in Europe, GCCL reduced transportation costs by approximately USD 3 billion and reduced turnaround times by 2-3 days. This cost-effective solution highlights GCCL's commitment to delivering value to clients.
In another project involving a Sample processing project across Asian countries, GCCL coordinated rapid sample processing and transportation to a specialized lab in Europe. This intervention successfully included Asian sites in the global project, demonstrating GCCL's adaptability and dedication to solving complex logistical challenges.
Through innovative solutions and a commitment to excellence, GCCL offers tailored solutions that elevate the quality and efficiency of clinical trials. As it expands its global footprint, GCCL is set to leave an indelible mark on the field, shaping the way clinical trials are conducted worldwide.
