Creation or coordination of the production of necessary trial documentation, including protocols, subject information and informed consent, Investigator’s Brochure and IMPD. Management of all aspects of study medication. Identification and selection of the best clinics or Contract Research Organizations (CROs) for the needs of the protocol, clear of any selection bias.
Pharmackt will select the best sites with the clinical expertise related to your study. Writing and submission of the clinical trial application and management of other regulatory aspects of the study Supervision by clinical trial team during preparation, execution and reporting phase Coordination of communication with CRO’s and other partners regarding timelines, budget and quality of the clinical trial Pharmacovigilance Data management GCP monitoring Statistics, analysis and reporting