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.
Product Development
Consulting and support for pharmaceutical product development as well as medical device development; full-service or partial development, due diligence, gap analysis and MDR compliance.
Medical Writing
Development of study designs, protocols, IMPD, investigator’s brochure, study reports, expert reports, CER/PMCF reports, lay summaries and patient materials.
Clinical Monitoring
Monitoring of investigator sites and study data; on-site, remote, central and risk-based monitoring, data review, reporting and GCP compliance.
Biostatistics
Statistical study planning, SAP preparation, statistical programming and analysis, TLFs, interim analyses, blind data reviews and regulatory review.
CRO Project Management for Clinical Trials
Project management for clinical trials from planning to close-out; coordination of sites, data collection, reporting and compliance with regulatory requirements.
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