BradyKnows provides full CRO services to the world’s 1st Integrated CT-Linear Accelerator. It is following innovative pathway for approval with 2-month NMPA review time and no queries on our 3-site 70-subject clinical trial.
| Brady Service Description | Duration | Brady Resource | Note |
|---|---|---|---|
| Full CRO service for innovative device (3 sites, 70 subjects, 3M follow up) | 12 months | *18 resources in total for clinical trial * Covering clinical operation department, medical affairs department, QA department, technical department, marketing department, PM department | *Through 3 rounds of open tender. *Competing with China’s top 3 pharma CRO companies. *No NMPA queries on clinical trial (approval during 1st round of NMPA review) |
| Site and PI selection | 1 month | Clinical Director * 1 Technical Director * 1 Marketing resources * 2 PM * 1 | 1 site in Suzhou and 2 sites in Wuhan |
| Protocol finalization and IRB/EC application preparation | 1 month | VP of Clinical and Medical Affairs * 1 Clinical Director * 1 Statistician * 1 MA * 2 PM * 1 | 3 sites 70 subjects 5 visits |
| IRB/EC approval and local NMPA filing | 1 month | Clinical Director * 1 CRA * 3 CRC * 3 PM * 1 | IRB/EC application for each site |
| Site kick off meeting | 1 month | Clinical Director * 1 CRA * 3 CRC * 3 PM * 1 | Training on PIs, sub-PIs, CRAs and CRCs of each site |
| Subject recruitment | 2 months | Clinical Director * 1 CRA * 3 CRC * 6 QA * 2 PM * 1 | Covered the tumors in six body parts |
| Subject follow up | 4 months | Clinical Director * 1 CRA * 3 CRC * 6 QA * 2 PM * 1 | *24h after therapy *1M follow up *3M follow up |
| Clinical monitoring and audit | 1 month | Clinical Director * 1 CRA * 3 QA * 2 PM * 1 | *Monitoring twice a month to each site. *Internal QC audit twice a month. |
| Data management + statistics | 1 month | Clinical Director * 1 CRA * 3 CRC * 3 Statistician * 1 MA * 2 QA * 2 PM * 1 | *Internal DM, statistics and MA team to fully support for saving time. *QA involves in to ensure data quality. |
| CSR + site close-out | 1 month | Clinical Director * 1 CRA * 3 CRC * 3 QA * 2 PM * 1 | Drafting CSR and site close-out preparations in parallel |
