What We Do

What We Do

 

Trial Planning

Identification of “Gaps” on literature
Trials Conception/drawing
Protocol development
Statistical Analysis
Budget forecast
Monitoring Plan
Management on support services (logistic, Courier, laboratory and others).

   
Academic Leadership

National Coordination
Participation on Executive Committees and Steering Committees.
Clinical Help Line
Validation of clinical events

   
Project Management Supervision of all the activities, clinical operation team, outsourced services and others.
   
Sites Management and Monitoring Sites Identification
Selection Visits
Initiation Visit
Monitoring
Close-out Visit
Recruitment activities
Site Trainings
Sites Internal Coordination
Data quality management
   
Regulatory Process Elaboration of regulatory package
Communication with Regulatory Authorities (CONEP and ANVISA).
Import Process Coordination
   
Clinical Events Classification(CEC) Physicians highly qualified and empowered that participate of clinical outcomes review and validation on high impact studies.
Process operational management.
   
Pharmacovigilance Collecting, clinical review and follow-up of adverse events.
Applicable Regulatory Agencies submission.
   
Quality

Quality Assurance on Clinical Trials conducting;
Sites evaluation with regard to actual Quality Management and possible consulting related to its improvement;
Implementation of Quality Management System in the Sites (focus on Normative Instruction nº 4, from ANVISA).
Conducting of Quality Audits.