Services

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