• Regulatory consulting
• Local applicant support
• Quality and data driven regulatory applications:
  Clinical Trial Permission, Test License, Marketing
  Authorization, Manufacturing License, Import &
  Registration spanning various products
• CTRI registration and updates
• Post approval maintenance
• Safety submissions

• Strategic consulting
• Project management
• Vendor management

• Project Specific Quality Compliance Assessments
• Independent GCP/Compliance Audits
• Standard Operating Procedure (SOP)/Work Instruction (WI) Development
• Pre-Inspection/Audit Preparation
• Quality Assurance Trainings

Team meticulously selects CRAs based on their experience in appropriate therapeutic area.

A strong training program then sets base for the interface between the project team and the Investigator, where CRAs demonstrate high levels of site management skills to ensure that issues at sites are addressed quickly and completely, allowing sites to work efficiently and maximize data quality.

• Drug Safety and Pharmacovigilance
• Medical Monitoring
• Medical Writing

CliniRx has an extensive experience in collecting, storing; analyzing, interpreting and presenting clinical data. Our in-house clinical data management experts are committed to upholding a standardized, process-driven approach by using the state-of-the-art tools such as Medidata, INFORM, etc. Our experienced biostatisticians are able to demonstrate efficacy of a drug or a medical device and present results in the clearest way possible. CliniRx complies with ICH/GCP, CFR PART 11, GDPR, and other data protection guidelines.