General planning of clinical and preclinical trials
Sites and investigators selection
Writing and/or translation and/or version of the Protocol / Clinical Report Form
Preparation, Submission and Follow up of the Clinical Trial Authorization / Health Minister
Ethical Comitee- orientation/ organization and colectionof the mandatory documentation
"Investigator Meeting" organization
CRAs training

Clinical Trial Implementation and monitoring
In absolute agreement with GCP and SOPs
Report per visit and site
Adverse Events Report
Time-table Trial Report - Indication of delays and progresses. Reasons and adopted solutions or solutions to be adopted
Qualifying, initial, periodic and close-out Visits

Data management /statistical evaluation / final report/ publication

Quality assurance in clinical trial
Frequent and aleatory audits assuring the time-table and the accomplishing of GCP and SOPs

APM - Associaçao Paulista de Medicina
AMB - Associação Medica Brasileira
Associação Brasileira de Farmacêuticos Homeopatas
Conselho Federal de Medicina
Organização Pan-Americana da Saúde/Brasil
Escola Paulista de Medicina - UNIFESP Sao Paulo
Faculdade de Ciências Médicas da UNICAMP Campinas
Faculdade de Medicina de Botucatu - UNESP -Botucatu - SP
Faculdade de Medicina da UFMG - Belo Horizonte - MG
Faculdade de Medicina USP - Sao Paulo

Faculdade de Medicina USP - Ribeirao Preto
Governo brasileiro
Ministério da Saúde

Instituto Nacional do Câncer
Complete list of links
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