China Region- Diagnostic Services
Almac Diagnostic Services has been working with Chinese partner labs for many years, supporting biomarker programmes on behalf of our key global Biopharma clients.
We have established strong trusting relationships with our partners, built the framework and put in place robust processes to enable Almac to support Chinese biomarker studies on behalf of our sponsors.
Almac can support your Genomic Services, Clinical Biomarker & CDx Development and Clinical Testing programs in China. Our partnership model enables Almac to be your one point of contact for multi-arm global studies, including the China region.
The China challenge for global studies
China’s National Medical Products Administration (NMPA), govern a regulatory system that differs greatly from US (FDA), EU (EMA), UK (MHRA) and other international regulatory markets.
China’s HGRAC guidance means that almost all clinical trials conducted by multinational companies in China will involve HGR (“Human Genetic Resources” – Samples and Data) and are subject to the regulation.
The regulation prohibits foreign parties from collecting and preserving samples in China, and further prohibits them from supplying samples outside China. Only Chinese parties are permitted to engage in collection, preservation or supply of samples. You need a partner like Almac that has key laboratory partner contacts in China to work with samples and data in the region.
Almac also understands the specific nuances of the China region to help deliver on your global study objectives including: Registration requirements, local testing coordination with NMPA through a local China based representative, a robust quality management system (QMS), clinical trial monitoring in China & post-market surveillance.
Why Almac?
By choosing Almac for your Chinese studies we offer clients the following benefits:
- Almac has audited and qualified partner laboratories in China to enable the transfer of Almac Assays, inclusive of any custom developed software.
- Technical oversight of these assays is maintained by Almac’s CLIA Laboratory and its Lab Director ensuring testing meets CLIA standards.
- Use of the Assay in Chinese based clinical trials is monitored regularly by the Almac clinical research monitoring team to ensure adherence to the clinical trial protocol.
- Almac has a dedicated Global Clinical Trial Monitoring Team to support clients, with knowledge of global regulatory regulations.
- Almac employ Global Clinical Trial Monitors whose native languages are Mandarin and Cantonese and who work with our China Lab partners to keep open lines of communication & promptly resolve any issues that may arise.
- Almac can assist Biopharma Partners with the HGRAC submission process.
- Almac can help you engage with NMPA through our local Chinese agent.
- Almac’s logistics teams have experience in working in collaboration with our Chinese lab partners to ensure a seamless transition of samples into the region.
- We have established a robust supply chain with our Chinese lab partners, navigating the complex import restrictions of China, to guarantee supply of lab reagents and sample collection kits to maintain clinical trial integrity.
Clinical Trial Monitoring of IVD Devices in China. Overcoming challenges with strategies for success
Clinical Trial Monitoring of IVD Devices in China. Overcoming challenges with strategies for success
The blog covers the following key topics: Challenges of Monitoring CTA and CDx Devices in China, including:
• Clinical Trial Regulatory Requirements
• Genetic Material
• Genetic Information
• Communication & Dialects in China
• Cultural Differences
• Commonplace Challenges of Monitoring in China
• How Almac Diagnostic Services has overcome these challenges
• Benefits of Working with Almac to monitor CTA and CDx Devices in China
Our China Partner Labs
Almac currently has agreements in place with the following Chinese lab partners to support your needs:
SEQUANTA
Sequanta Technologies is a leading multi-omics and clinical trial laboratory services organisation in China providing integrated services across scientific research and drug development process to pharmaceutical and academia customers. With a world-class facility of 3,000m2 certified by CLIA, CAP and ISO15189, Sequanta offers more than 300 research or clinically-validated assays including FoundationOne CDx, Illumina TSO500 for tissue and ctDNA, Olink Target 48/96 and Olink Explore 384/1536/3072.
Amoy Dx
Amoy Diagnostics Co., Ltd. (AmoyDx) is a pioneer and globally leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialisation. A rich product portfolio has been established with more than twenty products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS. With multiple technological platforms and full capability for companion diagnostics product development and commercialisation, AmoyDx has become an important diagnostics partner of many pharmaceutical companies around the globe.
Burning Rock Biotech Limited is a global diagnostics company focusing on applying next-generation sequencing (NGS) technology in precision oncology. Guided by the mission of “Guard Life via Science,” Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics (CDx) development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test. Burning Rock stands as a global collaborator in driving advancements in precision oncology.
Interested in partnering with Almac for your biomarker studies in China?
