Metronomia Clinical Research GmbH
Metronomia is a mid-size, owner-driven clinical research organization (CRO), located in Munich, Germany. The company offers high-quality clinical research services serving clients ranging from small biotech startups to global pharmaceutical companies, along with the medical device industry.
With more than 500 clinical projects successfully performed, Metronomia has a proven track record in all major therapeutic areas, throughout all clinical phases as well as non-interventional studies (NIS).
The company’s name is derived from the ancient Greek for “managing the measurable”, referring to Metronomia’s core mission to collect, process and provide high quality data in clinical research.Services
Metronomia offers a comprehensive suite of services.Full-Service in clinical trials phase I – IV and NIS
These services include:
- Statistics & statistical consulting
- Data management & e-clinical services
- Monitoring & project management
- Medical writing
- Market access support
In addition, a number of its clients have chosen Metronomia as a preferred partner for functional services in the companies’ core competence areas:
- Biostatistics and statistical consulting
- Data management
- E-clinical services
For some of these clients, Metronomia also took on the role as outsourced statistics- and/or data management department.Biostatistics
Metronomia offers a complete range of biostatistical services, performed by expert teams of clinical SAS programmers and biostatisticians. In-depth experience over a wide range of therapeutic areas, combined with profound understanding of ICH GCP, regulatory requirements and CDISC, ensures highest biostatistical quality throughout all stages of clinical development.
Biostatistic services include statistical planning of clinical trials, liaising with regulatory bodies, participation in DSMBs, preparation of Statistical Analysis Plans and generating CDISC SDTM and ADaM datasets.Statistical Consulting
Metronomia’s specialized expertise in biostatistics and e-clinical services, product development, statistical and regulatory compliance is available to biotech, pharma and medical device customers on a consultancy basis. Metronomia provides standard data processing and analysis along with the consulting services of its highly qualified professionals.
Statistical consulting services include study design for phase I-IV clinical trials, statistical planning, protocol development, participation in advisory board meetings, preparing and attending scientific advice meetings with regulatory agencies and participation in DSMBs.Clinical Data Management & e-clinical Services
Metronomia's high performance in clinical data management is founded in well-established standard operating procedures, implemented by highly-experienced clinical data managers supported by high-end clinical data management solutions.
With more than 25 experienced data management systems users, Metronomia has an impressive track record in completing large phase III trials as well as demanding phase I trials in oncology, with corresponding challenges on efficiency, quality and flexibility.
Metronomia supports all leading industry standard data management solutions including Oracle’s Clintrial, Medidata’s RAVE, and Quadratek’s clincase, supplemented by various in-house developed technologies.Monitoring & Project Management
Dedicated teams of continuously trained clinical research associates (CRAs) ensure consistent and effective monitoring of study sites, including pre-study, initiation, interim and close-out visits.Medical Writing
Metronomia can create high-quality and comprehensible clinical study protocols, study reports or value dossiers that meet highest scientific, medical and statistical standards.Quality Assurance
Metronomia’s QA system is based on a comprehensive set of standard operating procedures (SOPs) and highly-qualified professionals, working in accordance with ICH guidelines and standards with regard to IT security and validation of computerized systems.Market Access Support
Metronomia is expert in compiling data to align products with changing markets. It can support clients in planning and performing outcome research studies, statistical analysis and preparation of value dossiers, statistical support through indirect comparisons and meta-analysis and pharmacoeconomic analysis and studies.Background and Structure
Over more than 20 years, Metronomia has established a number of long-term partnerships, confirming its status as a stable, reliable and competent partner for any clinical project. Metronomia’s clients benefit from:
- excellent clinical trial know-how
- absolute commitment to personal service and outstanding flexibility
- stable project teams due to low employee turnover
- an attractive cost-benefit-ratio
Metronomia is led by Rudolf Köhne-Volland, M.Sc. in Statistics, Managing Director and Head of Biometrics, and Dieter Meyer, M.Sc. in Statistics, Managing Director and Head of Data Management, who co-founded the company in 1990.
Today, the company counts more than 50 employees and has gained vast experience acquired over hundreds of clinical projects.Contact
To learn more about Metronomia services and capabilities and how they can assist your business, please contact Metronomia directly.
- CRO, CMO, CRAMS & CDMO
- Clinical Trials & Studies
- IT & Data Management
- Training & Consultancy