Services We Provide

We offer customized consulting services for Clinical Research, In-vitro studies, Non-clinical, Quality Management Systems, Training. Refer our vast service portfolio below and reach out to us to understand your needs and serve you better.

Phase I-IV Clinical Trials oversight

  • CRO and Vendor audits (Data Management, Clinical Trial Supplies, Central lab, Interactive Web Response System)
  • Investigator site audits (Routine and for-cause)
  • Global Project Management
  • Inspection Readiness/Mock inspections
  • On-site/remote
  • Monitoring
  • Go-live audits, Interim project audits/Trial Master File review/Database audits

Quality Management System Set-up and Training services

  • QMS consulting and oversight
  • SOP development and review
  • Training on GCP/GLP, 21 CFR part 11, QMS, EUCTR, GDPR guidelines and clinical research topics
  • System /process audits and gap assessment/due diligence audits
  • Upskilling of manpower by targeted trainings

     

In Vitro Study data review:

  • In-vitro Bioequivalence studies
  • Biowaiver studies
  • In-vitro Permeability (IVPT) studies
  • In-vitro Release Test (IVRT) studies
  • In-vitro comparative studies
  • Mock Inspections/Inspection Readiness

BA/BE studies oversight

  • BA/BE CRO audits
  • Clinical phase in-process monitoring and data review
  • Bioanalytical phase in-process monitoring and data review
  • Inspection Readiness/Mock inspections
  • Auditing of BA/BE studies
     

Software validation review

  • Review of software validation strategy and plans
  • Review of software validation execution documents
  • 21 CFR Part 11 /EU Annex 11 compliance assessment
  • IT and computer system audits

Pharmacovigilance services

  • Audits and systems set up
  • SOP development
  • Inspection readiness
     

Medical Services system set-up & QA

  • Post Marketing Studies/Post Authorization Efficacy Studies/Post Authorization Safety studies
  • Disease Management and patient support programs
  • Marketing survey and research programs
  • Investigator Initiated studies/Scientific Study Research Support (IIS/SSRS)

Other Services:

  • Sponsor audits compliance &CAPA
  • Regulatory query response
  • Operational excellence models
  • Due-diligence
  • Quality Metrics design/ risk management
  • Centralised data digitalisation services.