Clinical Trials

Our services attend all steps of the clinical trial reducing timelines and costs.

Developments of clinical protocols phase I, II, III, IV and post-marketing.
Design and production of CRFs.
Site Qualification and feasibility analysis for best sites selection.
Monitoring (pre-study, initiation, monitoring and close-out visits).
Informed Consent form design and adequacy to local regulations.
Selection and training of Investigators and study coordinators.
Interaction with Laboratories (national and international) including the selection and set-up of services.
Development of instruction material to sites and laboratories including Investigators and Laboratory Manuals, advertisement materials, patient support materials and others.
Preparation and conduct of Investigators’ Meetings.
Certified technical translations
Preparation of regulatory packages, submission to the Health Authorities and follow-up until approval.
Support in the Ethics Committee documents submission.
Medical support for serious adverse events (SAEs) and SUSARs.
Experienced staff in the importation of clinical supplies process as well exportation of human biological samples.
Supportive and experienced staff in the management of clinical supplies logistics chain;