Clinical Research
Novocap is the leading CRO specialized in Bioavailability and Bioequivalence studies in Argentina. Our services include the following stages:
Regulatory Stage
Bibliographic search.
Protocol design.
Case Report Form design.
Informed Consent design.
Regulatory approval of protocol (by local authorities and committees).
Clinical Stage
Volunteers recruitment,
Pre-study clinical exams.
Selection and Approval of healthy volunteers.
Dosage administration
Sample collection and storage.
Post-study clinical exams.
Study monitoring and quality control.
Administración de las formulaciones.
Analytical Stage
Sample delivery and storage.
Quantification.
Critical points definition and control.
Statistical Stage
Statistical analysis.
Writing of Final Report (in spanish and/or english).
Critical points definition and control.
Study Coordination
Study general direction.
Coordination of the different professionals involved in the study.
Verification of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) compliance.
Publication
Report writing and submission for publication in local and international journals.
