World’s 1st Integrated CT-Linear Accelerator


2021-12-05

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 selection1 monthClinical 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 preparation1 monthVP 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 filing1 monthClinical Director * 1
CRA * 3
CRC * 3
PM * 1
IRB/EC application for each site
Site kick off meeting1 monthClinical Director * 1
CRA * 3
CRC * 3
PM * 1
Training on PIs, sub-PIs, CRAs and CRCs of each site
Subject recruitment2 monthsClinical Director * 1
CRA * 3
CRC * 6
QA * 2
PM * 1
Covered the tumors in six body parts
Subject follow up4 monthsClinical Director * 1
CRA * 3
CRC * 6
QA * 2
PM * 1
*24h after therapy
*1M follow up
*3M follow up
Clinical monitoring and audit1 monthClinical Director * 1
CRA * 3
QA * 2
PM * 1
*Monitoring twice a month to each site.
*Internal QC audit twice a month.
Data management + statistics1 monthClinical 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-out1 monthClinical Director * 1
CRA * 3
CRC * 3
QA * 2
PM * 1
Drafting CSR and site close-out preparations in parallel