Experience

Ecron Acunova

• Germany
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Research Associate

  • Dec 2021 - Present

  Preparation - study initiation documents, EC submission and approval, regulatory related documents, clinical update. SMF compilation Case report form reviewing Study handling as subinvestigator Preparation - study initiation documents, EC submission and approval, regulatory related documents, clinical update. SMF compilation Case report form reviewing Study handling as subinvestigator



AZIDUS LABORATORIES LTD

• India
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Research Associate

  • Dec 2020 - Dec 2021

  BA/BE studies Clinical research &Medical affairs Preparation - study protocol, clinical study report (eCTD - USFDA, EMA, Health Canada, INVIMA), study summary, informed consent form and case report form DCGI document submission & queries resolving BENOC & T-license applying AE & SAE reporting Secondary pharmacist BA/BE studies Clinical research &Medical affairs Preparation - study protocol, clinical study report (eCTD - USFDA, EMA, Health Canada, INVIMA), study summary, informed consent form and case report form DCGI document submission & queries resolving BENOC & T-license applying AE & SAE reporting Secondary pharmacist