Reliable Performance
 Absolute Accountability

• Timely identification of study violations and deviations are properly noted
• Required and appropriate explanation and clarification for deviations are present in the Investigator Site File
• Meticulous management of IP has been established for every pill, vial, liquid, injectable and every patient
• Safety Parameters, Required Reportable, Attributable Documentation (i.e., Hospital Discharge records) Risk 
• Management Analysis and Quality Assessments are properly collected, reported, processed and stored per Sponsor instructions
• All Essential Documents are properly handled and maintained in the Trial Master File​

Audit readiness is the key to meeting time sensitive deliverables and ensuring an FDA/ICH/GCP compliant clinical trial.  ProClinical Research Consultants target and reconcile the file to confirm: 

• Assurance that all subjects have been properly consented and patient safety per FDA/ICH/GCP guidelines are unequivocally practiced at the site
• Essential Document accuracy reflects current status of the study staff and site
  
• Leadership of Investigator shows accountability and adequate training of staff
  
• Documentation that legal, clinical, regulatory and ethical adherence and compliance has been and continues to be met
• Protocol execution for timely, accurate and complete source documentation and CRF entry
  

Targeted and Specific Monitoring

Protocols that are created to identify specific isolators and key endpoints are necessary for establishing parameters for maximum tolerated dose (MTD) and flexible interval dosing, chemistry compatibility and side effects.  ProClinical Research Consultants specialize in targeted monitoring details that provide our clients with only the data that they need when they need it. Targeted and Specific verification of data are offered for conventional monitoring as well as the areas noted below.

• Compassionate Care
  
• Orphan Drug
  
• Safety (Adverse Event, Pharmacokinetic, labs, vitals, baseline to EOS assessments)
  
• Unblinded IP Surveillance ​

Targeted Monitoring/Quality Auditing

Quality Control and Auditing Services