BradyKnows provides the least burdensome clinical solution to a global leader in precision radiation medicine, covering from clinical strategy to clinical evaluation report for full product pipelines. This client pays annual service fee to BradyKnows for a long-term partnership.
| Brady Service Description | Duration | Brady Resource | Note |
|---|---|---|---|
| Clinical Strategy for full product pipelines | 0.5 month for each product | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Technical Director * 1 Regulatory Director *1 | • For each product, BradyKnows team will make assessment and provide the least burdensome clinical solution. • e.g. for MRI-guided linear accelerator registration, CER was submitted for initial registration and provided clinical trial report during supplementary notice to save time. |
| Clinical Evaluation Report for initial overseas product registration | 1.5 month for each product | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Statistician * 1 MA * 3 Technical Director * 1 Regulatory Director *1 | • Identify NMPA approved equivalent devices (1-3 predicates) • Collect, analyze, and summarize non-clinical research data, clinical literatures, clinical experiential data, clinical research data on Chinese population, and adverse event data from Chinese and English • Collect, analyze, and summarize internal unpublished and submitted clinical data • Evaluate data quality, establish data sets, and conduct data statistical analysis • Conduct difference analysis between the product and its predicates and prepare the comparison table as per NMPA requirements • Write the final CER as per NMPA medical device clinical evaluation technical guidelines (China new CER guidelines have published) |
| Clinical Evaluation Report for initial domestic product registration | 1.5 month for each product | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Statistician * 1 MA * 3 Technical Director * 1 Regulatory Director *1 | • Domestic product is a localization of overseas product from this company. • Identify NMPA approved equivalent devices (usually the overseas product of this company) • Prepare the comparison table of all overseas and domestic products of this company, to expedite the CER strategy and predicate determination for each CER. |
| Clinical Evaluation Report for certificate modification | 1.5 month for each product | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Statistician * 1 MA * 3 Technical Director * 1 Regulatory Director *1 | CER for • Software upgrade • Expanding intended use • Adding new function |
| Local Manufacturing Consultation | 2 months | Regulatory Director * 1 QA Director * 1 Technical Director * 2 | Provide regulatory, testing, clinical pathway and QMS on its China localization |
