OmniacPharmConsult Ltd provides select suite of clinical development and medical affairs services to pharmaceutical and biotech companies.
Our clinical development expertise has played a key role in obtaining multiple health authority approvals of global and country-specific submission dossiers for new medicines and line extensions. Recent track record of consistently high standards and on-time project completion by focusing mission-critical documents for multiple successful projects within Oncology and Hematology including:
• CDP planning and execution
• Scientific evaluation and due diligence
• Medical monitoring
• Study protocols (Phase I-IV)
• Investigator brochures
• Clinical study reports
• Clinical summary documents for global submission dossiers (CTD format)
• Patient safety narratives
• Health authority briefing documents
• Submission-related responses to health authority questions
• Responses to pre- and post-approval health authority requests
During the trial conduct, Omniac provides medical monitoring, scientific review and query resolution of clinical data prior to database lock and quality assurance reviews of reports to ensure consistency with source data.Medical Affairs services include UK and Global Medical affairs expertise provided by Certified Final Signatories with significant experience in UK and European compliance and applicable codes of practice.
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