Services provided
Clinical Research
Clinical trials checking from the conception to their final report. Among other activities, it might include ANVISA meetings to discuss the adopted protocol.
Clinical trials supervision in the centre(s) of research (in situ visits) and/or remote monitoring according to the guidelines established in clinical good practises. Report writing for the sponsor and research centres. Preventive and corrective actions and trainings.
Support given to research centres to submit a study to your company’s Committee on Ethics on Research and Plataforma Brasil. Organization and keeping of regulatory files in the research centres and the sponsoring institution.
Databank compilation, organization and maintenance. It might include an electronic format.
Databank analysis and statistical description of clinical trial results.
Writing of the clinical trial final report according to the statistical results collected in the statistical data assessment.
Writing of efficacy and safety reports based on scientific literature.
Collecting of information regarding the technical bases, goals, outlining, methodology, sample number calculations as well as the study budgeting including the costs of the research centre(s) which will carry out the trial.
Descriptive report based on the scientific literature and other data sources such as international agencies regarding the feasibility of a clinical trial.
Scientific literature research, trial outlining, and writing of protocols and informed consent forms, medical records, etc. according to good clinical practises.
Writing and submittal of CDDDs (Clinical Drug Development Dossiers), according to ANVISA’s specific legislation and based on the documents supplied by the sponsor (including the final research protocol).
Selection and qualification of sites and investigators experienced in carrying out clinical trials according to the therapeutical area required by the trial sponsor.
Sponsor’s representation, taking the lead of their activities in the trial and including the clinical trial management, writing of the research protocol, selection and qualification of sites and investigators, regulation compliance checking in research, DDCM writing, and submittal at ANVISA, monitoring, data statistical assessment, trial reports, etc., including the importation of the analysed products.