For over 30 years, METRONOMIA has been an exceptional CRO partner for biostatistical services and consulting, clinical data management and medical writing.
Our team of 110+ highly skilled and committed employees serve the needs of our customers with the highest degree of flexibility, reliability and quality.
Our clients are pharmaceutical, biotech and medical device companies. Over 650 successful projects in all clinical development phases and major therapeutic areas are a testament to our data science excellence and exceptional service quality!
WHY US?
- Sustainable business relationships with >92% repeat business and a high staff retention rate.
- Exceptional customer experience through personalized service, and open, honest and proactive communication.
- Direct access to subject matter experts, statisticians, clinical data managers & medical writers enables maximum efficiency and adaptability to client needs.
- State-of-the-art knowledge, processes & technology
- Size matters! Our clients experience METRONOMIA as the “right”-sized partner – which always gives the “right” attention to their projects.
SERVICES
Biostatistical consulting
- Statistical and regulatory intelligence
- Strategic study design planning
- Statistical consulting based on state-of-the-art methods
- Active involvement in scientific advice meetings
- Modelling and simulation
Clinical Data Management
- CDASH compliant eCRFs
- Complete clinical data management package incl. data review & cleaning, medical review & coding, eCRF user management, helpdesk & support
- Vendor oversight support
- Vendor oversight support
- eCRF, ePRO, IRT, RTMS
- Systems:
- CLINCASE
- RAVE
- VIEDOC
Biostatistical Services
- Protocol and SAP development
- Submission support
- ISS & ISE analyses
- Comprehensive DSMB/IDMC support
- Randomization
- Non-clinical statistical services
- Vendor oversight support
Statistical Programming
- SDTM and ADaM datasets & submission ready CDISC packages
- TFL programming and validation
- Conversion of legacy data
Medical Writing
- Study protocols/ Clinical Investigation Plans
- DSURs
- CSRs, Clinical Investigation Reports & manuscripts
- Submission dossiers
- Non-clinical medical writing
IDMC Support Services
- Independent data center services and secure data storage/exchange
- Acting as central point of contact for sponsor and IDMC members
- Statistical services for interim analyses
- Management of committees including contracts, remuneration and meeting minutes
Partnered Full-Service and Tailored Service Packages
- Feasibility studies and site recruitment
- Project management, clinical monitoring, RBM
- Safety management
- Regulatory services
Trial Rescue Services
- Risk assessment and minimization
- Corrective and Preventative Action (CAPA) plans and implementation
- Project management and vendor oversight
- Uninterrupted data collection, processing, analysis and reporting
About Clinical Trials Innovation Programme 2023
Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.
Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2023 will feature tailored sessions presented by the leading experts from across the globe.
We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.