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A dvice in M edical I nvestigation and L ogistics for C ommunication A nd R esearch. http://www.amilcar.com.tn. A M I L C A R. The Universitary-linked Tunisian Medical Expert Organisation. Our goals. A M I L C A R - CRO. Support Tunisian biopharmaceutical industry
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Advice in Medical Investigation and Logistics for Communication And Research http://www.amilcar.com.tn A M I L C A R The Universitary-linked Tunisian Medical Expert Organisation
Our goals A M I L C A R - CRO • Support Tunisian biopharmaceutical industry • Promoting national clinical studies • Development of preclinical studies • Ensure a local monitoring of multinational clinical studies in Tunisia • Comply with International Conference on Harmonization • Promoting GCP
Our competence A M I L C A R A M I L C A R - CRO • CRT Feasibility • Protocol and CRF conception • Regulatory affairs, ethics,… • Monitoring, SAE management • Data Management, Statistical analysis • Medical writing • Quality assurance : Audit, ICH, FDA
Our team A M I L C A R A M I L C A R - CRO • Notorious clinical experts • Senior advisor in epidemiology and biostatistics • Experts in pharmacology • MD based Monitoring team • Computer scientist
Competence resources A M I L C A R A M I L C A R - CRO • Clinical Investigation Centers • Tunisian National Center of Pharmacovigilance. • Department of epidemiology and biostatistics, Medical Faculties. • Others competence …….
Our plan A M I L C A R A M I L C A R - CRO • Develop : • ICH-GCP’s in CRTs • Tunisian Clinical Investigation Centers • High quality SOPs • Electronic submission and data transmission • CRO partnership
Our strong points A M I L C A R A M I L C A R - CRO • Notoriety, High graduated team • A perfect knowledge of : • medical field • Policies, regulatory procedures, ethics,.. • AND +++ : our aim to reach highest quality
To reach an emerging market,we are constructing a strong frigate A M I L C A R A M I L C A R - CRO