Rita Alphonsa's Contact Details

Rita Alphonsa's Company Details

For Drug Consulting

Malakoff, Île-de-France, France • 22 Employees
Pharmaceuticals

ForDrug Consulting is a private contract safety organization (CSO) specialized in providing consulting services in pharmacovigilance (drug safety), clinical research, and quality assurance.1. Receipt, recording, and management of pharmacovigilance cases in SafetyE@sy (an E2B-compliant web-based drug safety database software that allows user-friendly data entry, analysis, search, and electronic reporting of cases). 2. Registration of products and electronic reporting of Individual Case Report Studies (ICRS) into the EVMPD (EudraVigilance) 3. MedDRA Coding and Causality Assessment by MDs headed by a Canadian university associate professor. 4. Global introspection and algorithm-based causality assessment schemes. 5. Medical writing (narratives, company comments, PSURs, Annual Safety reports, Risk Management Plans) by native English speaking medical writers (MDs and M.Scs). 6. Assistance in setting up a pharmacovigilance department 7. Quality Assurance (audits, updating SOPs) 8. Outsourcing competences in pharmacovigilance (MDs, pharmacists, scientists, database managers). 9. Training in pharmacovigilance (introductory and advanced studies). 10. Registration of drug companies and research centers with the EMEA, etc.