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 Trial Assay and Companion Diagnostic 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) and post-market surveillance.
By choosing Almac for your Chinese studies we offer clients the following benefits:
Experienced Project Managers- One point of contact
Almac Project Management staff have worked on multiple projects in China and can manage your study on your behalf. Your project manager will provide full assistance throughout the entire process. They will be your one point of contact, facilitating continuity across the global study delivery, including the Chinese laboratories.
Lab Vendor Management
- 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.
Ease of Contracting
We can support our global biopharma companies through the contracting process with Almac and our Chinese partners, easing the administrative burden.
- 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.
Almac’s data management team can support Biopharma clients in the development of data transfer agreements, where appropriate, ensuring compliance with HGRAC constraints.