Services

1. Bioequivalence / Bioavailability (BE/BA) Studies
   
2. Phase II-IV
3. Bioanalysis
   
4. Data Management and Biostatistics
   
5. Medical Writing
   
6. Special Population Studies (Patients / Post-menopausal Women)

Bioequivalence and Bioavailability (BE/BA) Studies
We conduct

• Fasting Studies
• Food Effect Studies
  
• Special Population Studies (Patients / Post-menopausal Women)
  
• Interaction Studies
  
• Multiple Dose And Steady State Studies
  
• Dose Linearity Studies
  
• InVitro - InVivo Correlation
  
• PK-PD Modeling

Phase II - IV Studies

We conduct

• Feasibility Study
  
• Protocol Development
  
• Site Identification
  
• Clinical Investigator Selection
  
• Clinical Study Monitoring
  
• Auditing
  
• Clinical Trial Co-ordination
  
• Clinical Trial Project Management
  
• Independent Ethics Committee Dossier Preparation
  
• Regulatory Submissions
  
• Post Marketing Surveillance (P.M.S.)
  

Data management and Biostatistics

Data Management

• CRF Annotation And Data Handling Manual
  
• Data Management Plan
  
• Customized Database Design and Development
  
• Data Entry With High Accuracy by Independent Double Data Entry
  
• Query Management Through Computer-generated Tracked Data Clarification Forms(DCF)
  
• Full Electronic Audit Trail
  
• Comprehensive Data Validation And Data Validation Reports
  
• Electronic Transfer (SAS Export Files)

Pharmacokinetics and Biostatistics

• Consultancy In Pharmacokinetic Strategy As Part Of Drug Development
  
• Study Design And Sample Size Calculations
  
• The Scientific Inputs For Developing The Collaborative Protocol Development
  
• Statistical Analysis Plan (SAP) Development
  
• Generation Of Randomization Schedule For Clinical Trials Using SAS Software
  
• Pharmacokinetic And Pharmacodynamic Analysis
  
• Study Sample Analysis Review And Handling Of Pharmacokinetic Repeats
  
• Statistical Programming (SAS Code Programming)
  
• Statistical Analysis And Preparation Of Statistical Reports
  
• InVitro - InVivo Correlation