Risk-Based Monitoring in BA/BE/Clinical phase (Healthy & Patient) Studies.
- System and Facility Audits
- CRO Qualification: System and Facility Audits
- GAP Audit
- Qualification/Re-qualification Audits
- Retrospective GCP – Study Specific Audit
- For-Cause Investigative Audit
- Pre-inspection readiness Audit
- Pre-clinical audit
- Data Integrity and Compliance Assessments
We offer complete support in PK stat which starts from Study Design finalisation to final review of PK stat report/SAS Out put.
CRO SETUP & UPGRADATION: IN COMPLIANCE WITH USFDA/EMA/ICH
- GAP analysis of the quality System vs new EU-CT regulation and ICH E6 R2
- Inspection Readiness Support (Sponsor, CRO, Investigational Site, Back & WarRoom)
- SOPs/Policies Development, Issuing and Review
- Clinical Process mapping
- Compliance support
Site Identification, Feasibility, Audit, and Selection through budget finalization, Protocol Review, Complete coordination and Monitoring of Study from Start to end till Final Closeout and report submission.
- Bioequivalence Study Design
- Clinical Study Setup
- Compliance Verification with minimal technical requirements for clinical sites involved in Bioequivalence studies
- Risk Management Support
- CRO Selection support
- Archiving Requirements for Study Documents
Learner Centric Approach
From basic GxP to advanced specific trainings
- Our Experienced subject matter experts provide correct training on all GXP topics, Policies, Procedures, Documentation, Data Integrity and Customized topics to enhance operational excellence and serve as best tool to mitigate risks at cost effective manner.
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- Our Experienced subject matter experts provide correct training on all GXP topics, Policies, Procedures, Documentation, Data Integrity and Customized topics to enhance operational excellence and serve as best tool to mitigate risks at cost effective manner.
Learn More...