Clinical Trial Monitoring
Clinical Trial Monitoring
Clinical Trial Monitoring Team
Experienced Team
Almac Diagnostic Services has a dedicated Global Clinical Trial Monitoring Team, experienced in Monitoring Clinical Device Trials globally. Our team ensure effective and efficient Clinical Trial Device Monitoring across a range of diverse diagnostic device technologies (such as qPCR, NGS, NanoString, IHC, ELISA).
Independent Analysis
The Global Clinical Trial Monitoring Team are independent from our Clinical Device Trial Delivery and Clinical Testing teams; and report directly to Almac Diagnostic Services Global VP & Medical Director, enabling rapid decision making & resolution.
Qualifications & Language Proficiency
Many of our team hold PhD academic qualifications in areas relevant to Diagnostic Devices, to ensure compliant and effective Clinical Device Trial Monitoring. Additionally, Almac employ native language speakers (Mandarin, Cantonese, etc.) to support the specific challenges in Device Trial delivery and Device Trial Monitoring in China.
Clinical Trial Monitoring Service
Global Clinical Trial Monitoring confirms Clinical Device Trials are conducted in adherence with ICH Good Clinical Practice (GCP), applicable regulatory requirements (e.g. Clinical Performance Study Plan (CPSP), Investigational Device Exemption (IDE), In Vitro Medical Devices Regulation (IVDR), and other specific client requirements. Furthermore, it enables alignment of Clinical Device Trial delivery globally ensuring patient safety and data integrity, while also supporting future product approvals.
Almac Diagnostic Services has rigorous monitoring procedures established which meet global regulatory requirements (ICH GCP, IVDR, ISO 20916, IDE, & Human Genetic Resources Regulation) throughout the trial duration; guaranteeing effective, efficient, and compliant visits are conducted, including:
- Site Initiation Visits (SIVs)
- Interim Site Monitoring Visits (SMVs)
- Site Closeout Visits (SCVs)
Our monitoring strategies are flexible and risk based enabling us to meet client and clinical device trial requirements. We can adjust the frequency of SMVs and the depth of Source Data Verification (SDV) as necessary, while maintaining patient safety and data integrity.
Core Areas Audited During Site Visits
Clinical Trial Monitoring in China
Our Global Clinical Trial Monitoring Team are experienced in the challenges of Clinical Trial Device Monitoring within the China region.
- Use of an assay in Chinese based clinical trials is monitored regularly by the Almac Global Clinical Trial Monitoring Team to ensure adherence to the clinical trial protocol.
- Almac’s Global Clinical Trial Monitoring Team support clients with knowledge of global regulatory regulations including China.
- 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.
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 programmes in China.
Our partnership model enables Almac to be your one point of contact for multi-arm global studies, including the China region.
Find out more on our China Region Diagnostic Services
Blog:
Read our latest blog entitled ‘Clinical Trial Monitoring of IVD Devices in China. Overcoming challenges with strategies for success’.
Contact Us
For further information on how we can support Clinical Device Monitoring within your Clinical Trial, simply fill in the form below and we will be in touch to discuss your specific requirements.
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