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Clinical Trials (phase II - IV)

Therapeutic Equivalence (non-Inferiority) & Superiority Studies  for Locally Applied/Acting & Fixed-dose Combination Products

Investigator Sponsored Studies

Observational Studies

  • Protocol, CRF & ICF development
  • Study conduct
  • Statistical analysis
  • Clinical Study Report

Bioequivalence Studies

  • Clinical phase
  • Bioanalysis
  • Pharmacokinetics & Biometrics
  • Clinical Study Report

Monitoring

  • Initiation, Monitoring & Close-out visits

Data management & Biometrics

  • e-CRFs, Databases & Registries
  • Data management & Statistical analysis plans
  • Data analysis
  • Medical Scientific writing

Pharmaceutical Market Research

  • Questionnaire design
  • Web-based surveys
  • Statistical analysis & Report

Pharmaceutical Advisory Boards

  • Program development & Recruitment of group of advisors
  • Questionnaire design & Surveys
  • Statistical analysis & Report

Regulatory Affairs

  • Module 2 CTD - Clinical & non-Clinical Overviews, Well Established Use
  • Scientific & administrative support of regulatory queries, Expert Reports
  • Type II Variations & Renewals
  • Regulatory dossier compilation, evaluation & submission to IRBs
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