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Data Science and Operations

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)
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Medical Writing and Operations

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
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Clinical Research and Operations

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
  • Subject enrollment
  • Data collection and monitoring
  • TMF management
Close-out
  • Close-out visits 
  • Final device accountability
  • Audit preparation
Central Lab and SMO
  • Central lab selection and qualification
  • Selected central lab services via OcTech Lab
  • SMO management
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Regulatory Consulting

Experienced regulatory consultants to provide comprehensive, global regulatory strategy for all classes of medical devices and IVDs
  • 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
  • FDA submissions including pre-sub, IDE, 510(k), De novo and PMA
  • NMPA submissions
Regulatory agency liaison