Data Science and Operations+ 更多
Data Science and Operations
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Clinical Study Design
Strategic Plans & Program Development
- Early phase clinical studies
- Pivotal and confirmatory studies
- Post-market studies
Clinical Study Operations
- Create randomization; Develop SAP and TLFs shells
- CRF creation and review; Database development; Data management
- CEC and DMC support including interim analysis, SSR
Analysis of Study Data
- Creation and validation of analysis datasets, TLFs
- Statistical interpretation (statistical reports and publications)
- CDISC compliant datasets (SDTM and ADaM)
Regulatory Submissions & Scientific Communications
- FDA questions/meetings/panel discussions/China NMPA interaction
- Advisory Committee Support and DSMB (voting and non-voting)
Medical Writing and Operations+ 更多
Medical Writing and Operations
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Strategic Plans & Program Development
- Early phase clinical studies
- Pivotal and confirmatory studies
- Post-market studies
Clinical Evaluation
- Define evaluation scope
- Data collection, comparison and assessment
- Clinical evaluation report
Meta-analysis
- Meta-analysis plan development;
- Literature search; data extraction
- Risk of bias assessment; meta-analysis report
Clinical Study Design
- Residual risk assessment
- Support study design from medical perspective
- Negotiate with regulatory agencies (FDA, China CMDE etc.)
Medical Documents & Reports
- Study protocol development
- IB/ICF development
- CSR development
Clinical Research and Operations+ 更多
Clinical Research and Operations
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Strategic Plans & Program Development
- Early phase clinical studies
- Pivotal and confirmatory studies
- Post-market studies
Start-up
- Investigator and site selection
- Contract and budget negotiation
- Site initiation
Execution
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- Subject enrollment
- Data collection and monitoring
- TMF management
Close-out
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- Close-out visits
- Final device accountability
- Audit preparation
Central Lab and SMO
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- Central lab selection and qualification
- Selected central lab services via OcTech Lab
- SMO management
Regulatory Consulting+ 更多
Regulatory Consulting
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Experienced regulatory consultants to provide comprehensive, global regulatory strategy for all classes of medical devices and IVDs
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- Develop novel regulatory plans with options to tailor specific product
- Integrate with biostatistics, study design and medical writing
- Frequently interact with the Regulatory Agencies on behalf of clients
Support regulatory submission preparations and negotiations
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- FDA submissions including pre-sub, IDE, 510(k), De novo and PMA
- NMPA submissions
Regulatory agency liaison
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