Successful Case Study

World’s 1st Integrated CT-Linear Accelerator

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

A Global Leader In Precision Radiation Medicine

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

World’s Innovative Cancer Care Solution Manufacturer

BradyKnows provides full regulatory services to this world’s innovative cancer care solution manufacturer, covering the regulatory strategy, import customs clearance, onsite type testing, dossier preparation, initial registration, modification, renewal etc.

Brady Service Description	Duration	Brady Resource	Note
Regulatory and 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 regulatory and the least burdensome clinical solution. • e.g. how to balance certificate renewal and modification; if modification is required for software upgrade
Registration for initial overseas product	18 month for linear accelerator	Technical Director * 1 Onsite test engineer * 1 Regulatory Director 1 Sr. RA 2 PM * 1	• Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample import and delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information
Registration for initial domestic product	14 months for linear accelerator	Technical Director * 1 Onsite test engineer * 1 Regulatory Director 1 Sr. RA 2 PM * 1	• Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information
Certificate modification for software upgrade	12 months for software upgrade	Technical Director * 1 Onsite test engineer * 1 Regulatory Director 1 Sr. RA 2 PM * 1	• Prepare checklist of registration for tracking project schedule • Prepare type testing dossiers, including Product Technical Requirement (PTR) • Coordinate sample delivery • Select appropriate test center • Onsite support testing • Prepare registration dossiers • Train and help on software description document, cybersecurity document and service life document as per China unique requirement • Do E-filing for registration dossier submission • Communicate with NMPA on queries • Confirm certificate information
Certificate modification for manufacturing site change	4 months for manufacturing site change	Regulatory Director 1 Sr. RA 1 PM * 1	• Prepare checklist of manufacturing site change for tracking project schedule • Prepare manufacturing site change documents (e.g. risk management report) • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information
Certificate modification for legal agent change	1 month for legal agent change	Regulatory Director 1 Sr. RA 1 PM * 1	• For all 18 certificates of this client to change legal agent • Prepare checklist of legal agent change for tracking project schedule • Prepare documents for legal agent change • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information
Certificate renewal	2 months for certificate renewal	Regulatory Director 1 Sr. RA 1 PM * 1	• Map out strategy to do certificate renewal first or do modification first • Prepare checklist of certificate renewal for tracking project schedule • Prepare documents for renewal • Do E-filing for dossier submission • Communicate with NMPA on queries • Confirm certificate information
Import customs clearance consultation	0.5 month	Regulatory Director * 1 QA Director * 1 Sr. RA * 1	For the import of products for testing, provide consultations on the import process, model selection strategy for import, the customs clearance statement from test center etc.

NMPA First Approved ENT Active Implant With Real World Data

BradyKnows provides the turnkey regulatory and clinical solutions to NMPA first approved ENT active implant with real world data. It is following Hainan urgent use policy to collect real world data integrated into clinical evaluation report (CER) for NMPA approval. BradyKnows services to this client cover the strategy, registration, type testing, clinical study, clinical evaluation report writing, post-market surveillance, new product R&D etc. for all product pipelines since 2015.

Brady Service Description		Time	Brady Resource	Note
Strategy map-out and refreshing		Oct, 2020	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 PM * 1	* Refresh the strategy corresponding to the upgrade of regulations and policies. *Assess the benefit and risk of new policies.
Type testing	Fixture preparation	Mar, 2021	RA * 2 RA Director * 1 Technical Director * 2	As per the actual situation, adjust and prepare the fixtures.
	Type testing technical meetings	Oct, 2020-April, 2021		Discuss the test protocol.
	Hospital MR safety test	April, 2021		MRI test environment setting up.
Clinical Evaluation Report writing and revision		Nov, 2020-July, 2021	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 MA * 2 RA * 2 PM * 1	Analyze the predicates and the products from competitors. Search literatures. *Search related surgery data.
Surgeon survey		Mar, 2021	CRC * 2 CRA * 2 Clinical Director * 1 Clinical VP * 1 PM * 1	Collect and compile the intra-operative and post-operative safety data, including complications.
Hainan Real World Study	RWS pathway assessment	June, 2020	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 PM * 1	Analyze China’s new RWS guideline Assess the benefit and risk of RWS pathway
	Data collection plan and protocol	June, 2020	Clinical Director * 1 Clinical VP * 1 Technical Director * 2 RA Director * 1 MA * 2 PM * 1	Analyze the related product guidelines, NMPA clinical guidelines and overseas clinical data to prepare protocol
	RWD Application Pilot Program (Fast Track pathway)	July, 2020	RA * 2 Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 PM * 1	Collect product dossiers to prepare Fast Track documents Include RWS protocol, CER, and innovation documents etc.
	Pilot Program Expert Panel Meeting	Oct, 2020	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1	Competing with other 80+ medical devices Do presentations and handle experts’ questions on the meeting *Two implants approved as Fast Track Program products (one of 9 manufacturers with 14 medical devices approved in total)
	Patient follow up	Since Oct, 2020	CRC * 2 CRA * 2 Clinical Director * 1 PM * 1	*Schedule patient visits to avoid COVID impacts
3rd party testing and report recognition assessment		Mar, May, July 2021	RA * 2 Technical Director * 2 RA Director * 1	Analyze the specific requirements of regulations and guidelines Assess the testing qualification of 3rd party test labs *Prepare corresponding test protocols
Product dossiers preparation		Oct, 2020-July, 2021	RA * 2 Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 MA * 2 PM * 1	Cross-check FDA published data Multiple confirmations on the consistency in original product data from IFU, PTR, internal V&V reports etc.
Mock-up review		May-July, 2021	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 RA * 2 PM * 1	*Internal at least three rounds of mock-up review and guess the potential queries from the perspective of technical and clinical reviewers
Submission		Aug, 2021	RA * 1 RA Director * 1	*No technical queries on NMPA pre-review
Handling NMPA Queries		Sep-March, 2022	Technical Director * 2 RA Director * 1 Clinical Director * 1 Clinical VP * 1 RA * 2 MA * 2	Multiple phone calls and online meeting with reviewers to do educations about product Prepare slides to summarize product features and handle queries from NMPA
NMPA Approval		June 2022 and July 2022		Two active implants approved.