Clinical Research Services

iuvo is a leading clinical research services company with experience and expertise over a wide range of medical specialties and therapeutic areas  – with an emphasis in ophthalmology from the front of the eye to the back of the eye.

  • Project leadership and accountability
  • Development and maintenance of project-related plans, procedures and logistics
  • Budget/resource allocation management
  • Market assessments
  • Market research
  • Strategic planning consultation
  • Medical product registration
  • Site recruitment and qualification
  • Site training
  • Patient recruitment
  • Study monitoring and site management
  • Tactical market assessments
  • Market research
  • Product assessments
  • Product launch
  • Product marketing
  • Product sales
  • Clinical investigator brochures
  • Clinical study protocol documents
  • “Instructions for Use”
  • Pre-clinical and clinical study reports
  • Manuscripts
  • Posters
  • PowerPoint presentations;
  • White papers
  • Audits/FDA inspection support
  • GCP seminars
  • Clinical SOP development
  • Data entry/processing/CRF  review/query resolution
  • Data dictionary processing
  • Data imports/exports
  • Data QA
  • Database lock/transfer
  • Database maintenance/archival
  • Security procedures
  • Study design input
  • Sample size/power analysis
  • Protocol development
  • Randomization schedule development
  • CRF schedule development
  • CRF review
  • Statistical methodology consultation
  • Statistical analysis plan development
  • Analysis data set specifications
  • Interim statistical analyses
  • Customized data listings
  • Final statistical tables/listings/figures
  • Review/interpretation results
  • Ad-hoc exploratory analysis
  • Scientific presentations/journal articles/QC of tables
  • Analyses data sets

iuvo’s experience with clinical study inspections by relevant regulatory authorities is integrated into our audit procedures. We work closely with you to clearly establish audit objectives, gain a detailed understanding of the study protocol history, review observations made during ongoing study monitoring, and to understand previous issues identified by relevant regulatory authorities. This helps us optimize audit results.

Following a comprehensive audit plan, our auditors work discreetly onsite to identify procedural deficiencies. When we review, we’ll include our assessment of the seriousness of the deficiencies noted and a proposed plan for addressing them.

  • Good Clinical Practice (GCP) audits
  • Good Laboratory Practice (GLP) audits (you can use image-6 near this)
  • Onsite assistance with FDA BIMO inspections