The core activity of Mediconomics is the provision of services for research and development projects in the field of pharmaceuticals, medical devices and development candidates, including clinical trials, pharmacovigilance, medical writing, regulatory affairs and clinical data management. The company offers full-service solutions for clinical development and consulting to pharmaceutical, biotechnology and medical technology companies.
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Planning, conduct and analysis of clinical trials for pharmaceutical, biotechnology and medical technology companies; full-service support from study conception to approval.
Clinical Trials
Clinical trials in phases I-IV with study planning, protocol development, project management, recruitment, monitoring, site management, statistics and final report.
Regulatory Affairs
Regulatory consulting and support for clinical trials and medicines; CTIS management, eCTD submissions, approvals, variations, notifications and life-cycle management.
Clinical Data Management
eCRF design, database design, data entry, coding, query management, quality control, database lock, CDISC-compliant data delivery and SAE reconciliation.
Pharmacovigilance
Drug safety for approved and clinical products; PV systems, safety databases, PSURs, DSURs, ICSR reports, RMPs, PSMF and audits.
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