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 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

READ MORE >

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 pipelines0.5 month for each productVP 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 registration1.5 month for each productVP 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 productVP 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 productVP 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 Consultation2 monthsRegulatory Director * 1 QA Director * 1 Technical Director * 2Provide regulatory, testing, clinical pathway and QMS on its China localization

READ MORE >

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 DescriptionDurationBrady ResourceNote
Regulatory and Clinical Strategy for full product pipelines0.5 month for each productVP 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 product18 month for linear acceleratorTechnical 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 consultation0.5 monthRegulatory Director * 1 QA Director * 1 Sr. RA * 1For 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.

READ MORE >

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.

READ MORE >