Therapeutic Expertise

In Vitro Diagnostic Services - Assist You to Develop a Successful Dx Product 

 

Service options

 

Clinical Study Design

 

  • Provide input on site selection, inclusion/exclusion criteria, etc.
  • Provided input on optimal sample type and collection procedures
  • Site selection and evaluation

 

Patient Enrollment and Sample Collection

 

  • Develop patient enrollment and retention (if applicable) plans
  • Provide on site training and monitoring of sample collection
  • Determine sample transit and storage logistics
  • Monitor patient data

 

Clinical Data Management

 

  • Build clinical data base and  perform biostatistical analysis
  • Combining clinical outcome with analytical data to determine clinical validity and utility of Dx test
  • Build algorithms for multiplex tests if applicable

 

Regulatory Submission (European and US)

 

  • Strategic Regulatory Plans -- understanding the road to market
  • Investigational Device (IDE) Submissions
  • Pre-Market Approval (PMAs) Applications and Pre-Market Notification Submissions (510k’s)
  • EC  and country authority submissions in Europe

 

Hua Gong, MD, PhD - IVD Executive Director

 

  • Over 12 years of working experience in developing biomarker /diagnostics tests for Oncology, RA, IBD, IBS, and CNS diseases
  • Successfully led multi-million dollar collaborations with pharmaceutical companies in developing companion diagnostics
  • Extensive experience in clinical study design for clinical validation and clinical utility studies  required for IVD development
  • Extensive experience of developing biomarker assays using multiple technology platforms including Protein microarray, genotyping, microRNA profiling, mutation analysis, gene expression profiling, ELISA, MSD, HPLC etc.
  • Strong network with KOL in multiple disease areas including oncology, autoimmune and CNS
  • Familiar with the requirements for FDA IVD clerance


Supported by team of medical device / IVD experts in Study Start up and submissions team and our dedicated clinical operations group with country based local CRAs in US and Europe.