Auditing and expert consultation services

Auditing CRO Clinical, bioanalytical and related facilities as part of qualification of CRO for Bioequivalence studies

1. Assessing performance of CRO through providing standard questionnaire for CRO self appraisal (standard questionnaire In line with GCP / Regulatory requirements)
   
   
2. Evaluation of CRO self filled standard questionnaire & To get further clarity on any questions on need basis
   
   
3. Auditing CRO facilities related to suitability for Bioequivalence studies
   
   
4. Audit report with observations related to
   • Adequacy of systems
     
     
   • Compliance to written systems
     
     
   • Compliance of in-house systems related to regulatory requirements ,GCP and GLP
     
     
   • Other observations and recommendations
     
     
   • To conclude suitability of CRO for intended bioequivalence studies for Europe and other regulatory submissions
     
     
   • And any other important factors
     
     

Training the team related to Bioequivalence studies designing, execution and conclusions

1. General aspects of Bioequivalence studies
   
   
2. Study designs ( 2 way,3 way,4 way ,parallel etc)
   
   
3. Biowaivers considerations
   
   
4. Understanding pharmacokinetics related to biostudy design (Linear, nonlinear, time dependent etc)
   
   
5. Explanation related to various elements of bioequivalence studies with relevant case studies.
   • Ethics committee
     
     
   • protocol preparation, approval
     
     
   • fed / fasting / steady state requirements
     
     
   • Adverse events
     
     
   • Biostudy monitoring
     
     
   • Sponsor responsibilities, etc
     
     
6. Regulatory authority specific technical requirements (Europe, Brazil, etc)
   
   
7. SOP requirements for Sponsors
   
   
8. Trial master file requirements for sponsors
   
   
9. Sponsor audits by regulatory authorities
   
   
10. Any other biostudy related aspects

Expert opinion / Technical inputs for designing Bioequivalence studies

1. Selection of strength for Bioequivalence studies
   
   
2. Decision on Fasting, fed, steady state requirements of project
   
   
3. No of subjects & Time points, Acceptance criteria
   
   
4. Specific study monitoring aspects based on safety and important clinical aspects of particular product
   
   
5. Regulatory requirements for specified territories for particular product
   
   
6. Other study / product related aspects
   
   

Bioequivalence study monitoring at CRO’s

1. To monitor bioequivalence study, being conducted at CRO (Monitoring refers to one bioequivalence study)
   
   
2. To prepare and Issue report related to study monitoring
   
   

Review and expert comments on bioequivalence study results received from CRO

1. Outliers
   
   
2. Statistical verification
   
   
3. Acceptance criteria
   
   
4. Safety assessments
   
   
5. Other observations
   
   

Compliance verification of bioequivalence studies conducted in the past (Old studies) for new regulatory submissions

Statistical applications related to dissolution profile comparisons

1. Model Independent Multivariate Confidence Region Procedure
   
   
2. Model Independent Multivariate Confidence Region Procedure