Page 9 - ADAMAS Brochure

Our range of GCP services Include:
▪ Investigator Site Audits
▫ Routine Investigator Site Audits
(Phase I to IV)
▫ Targeted Investigator Site Audits (Phases I to IV)
▫ For Cause Investigator Site Audits (Phases I to IV)
▪ System Audits
▫ System Audits of Sponsor/CRO/
Phase I/BA/BE/ARO Operations
▪ Mock Inspections
▪ Document Audits
▫ Protocol Audits (all Phases)
▫ Case Report Forms
▫ Informed Consent Forms
▫ Investigator Brochures
▫ Clinical Study Reports
▫ Development Safety Update Reports
▪ Vendor Audits
▫ Monitoring and Project Management ▫ Data Management, Biostatistics
▫ Inspection Preparation and Training (Investigator Site/Sponsor/CRO)
▫ Mock Inspections
▫ Inspection Facilitation
▪ Data Management
▫ Database Audits
▫ Data Management System Audits
▪ Trial Master File (TMF)
▫ TMF Audits (paper and electronic)
and Medical Writing
▫ Clinical Trial Supply
▫ Interactive Response Technology
▫ Translation Services
▫ Archive Facility
▫ Centralized ECG/Imaging Facilities
▪ Consultancy Services
▫ SOP Development
▫ QMS Evaluation
▫ Regulatory Intelligence
www.adamasconsulting.com