Biostatistical services
Statistics, our purpose and our passion!
At METRONOMIA, our biostatisticians and statistical programmers work closely together and with you via a harmonized approach to biostatistical service delivery, from conception to completion of your projects/programs.
Following the highest industry standards, we ensure your data is analyzed, visualized and reported optimally, to achieve the full potential of your clinical project or program. In cooperation with our fully integrated data management teams, data is skillfully defined, captured, reviewed and outputted, allowing for high efficiency and quality in the delivery of results from start to finish.
We speak your language! Whether you are a seasoned statistician or have no statistical knowledge whatsoever, we take the time to understand your needs and to explain to you options and recommendations meaningfully. With limited staff turnover, METRONOMIA is able to offer customers dedicated teams that learn your culture, follow your objectives and understand your data.
Entrust METRONOMIA with your biostatistical needs for clinical, observational or real-world studies, and become one of our long-standing, satisfied customers.
Depending on your needs, your team at METRONOMIA can act as an external biostatistical department or as a single data centre!
Biostatistical services comprise:
- Study design consulting
- Sample size calculations and simulations
- Contributing statistical input to the study protocol
- Review of study protocol and CRF
- Statistical analysis plan (SAP) development
- ISS/ISE planning
- Representation at regulatory agency meetings (FDA, EMA, BfArM, and others)
- SAS programming and independent validation of statistical output
- CDISC deliverables (SDTM, ADaM, define.xml files, reviewers guide)
- CDISC conversion of legacy data
- Integration of data across studies, ISS/ISE programming
- Patient profiles and ad-hoc reports
- Statistical modeling & simulation
- PK/PD analysis and modelling
- Strategic, statistical consulting and representation
- (i)DMC management, support and participation
- Management of charter development and input
- Provision of Independent Statistician and voting (i)DMC Member
- Role as independent data coordinating / statistical center
- Programming and distribution of statistical outputs for (i)DMC or interim analysis
We ensure compliance with ICH-GCP E6 (R2) oversight obligations on your behalf for outsourced statistical and data management functions:
- Subject matter experts (SMEs) in stats and clinical data management provide oversight
- High quality review of documents and deliverables received from vendors
- Expert input to oversight management plan
- Risk-based oversight activities compliant with ICH-GCP E6 (R2)
- Support of vendor selection
- Tailored implementation of Stats and clinical data management relevant KPIs
- Statistical reports
- Clinical study reports (ICH E3 or TransCelerate standards)
- CDISC and FDA submission compliant packages and documentation
- Topline and final analysis results packages
- DSURs, PSURs
- Manuscript development
- Publication of study results to EudraCT and clinicaltrials.gov
- Consultation and evaluation pertaining to project status, options and needs
- Scalable services from limited scope of work to full-service, operational support
- Extensive project rescue experience at different stages and service levels
- Development of randomization schedules
- Independent randomization services
- Design of Experiments (DoE) using Design-Expert
- Analysis plans
- Sample size calculations and simulations
- Statistical analysis and data visualization technique consultation
- Statistical evaluation
- Statistical input to CMC experiments
- 3R-Principle implementation for in vivo models
We offer a wide range of statistical consulting services, please read more
As a CDISC Gold member, Metronomia offers extensive CDISC support, please read more
Our medical writing team documents your scientific results to the highest quality standards, please read more
Standards in Statistical Programming
- Analysis datasets according to sponsor specifications and/or industry standards, i.e. CDISC standards
- Comprehensive Good Programming Practices integrated in SOPs
- Detailed program QC/validation plans
- SAS® macro validation in line with regulatory requirements and industry standards
- Comprehensive library of validated SAS® macros and SAS program modules
- Extensive SAS® ODS functionality use for enhanced and easily readable outputs
Statistical Systems
- SAS®
- R®
- Comprehensive library of validated SAS® programs and macros
Case Study
A journey from preclinical research to marketing authorization – as outsourced statistics department and single data center for a Munich based biotech company.
From 1999 to 2014, METRONOMIA supported the client’s project development process – from preclinical investigation through to accelerated FDA approval. During this 15-year period, METRONOMIA was instrumental in the provision of:
- Statistical planning and consultation for the entire program
- Statistical representation at various regulatory meetings at FDA and EMA
- Integrated statistical services with high flexibility and short response times
- Agile and efficient data management services for all clinical studies
- Statistical programming and analysis for all clinical studies, including integrated analyses for regulatory purposes
Advantages of METRONOMIA as your outsourced Data Management or Stats partner:
- A dedicated team of data management and statistical experts that acts as an extension of your clinical team and in the interest of your project and company objectives
- Outsourced service oversight conducted by the owner-operators of METRONOMIA with 30 years of experience, and by exceptional quality assurance processes and personnel
- An extensive library of statistical methodologies and models successfully implemented in the major disease areas
- Experts in associated risk identification, categorization and mitigation.
- An unbeatable track record of studies delivered responsibly on time and on budget
Advantages of Metronomia as your Single Data Center:
- Maximized efficiency through one fully integrated team of biostatistical and data management experts in tuned with your company culture and dedicated to your needs
- Guaranteed continuity and consistency from conception to completion of projects/programs through harmonized study designs, development plans, data structure and reporting, for the smoothest journey possible to marketing authorization.
- Guaranteed guardianship of your data! Reduce the risk related to a “one-stop shop” full-service CRO relationship, which, should the services be lacking, may result in future full or partial rescue of your project/program.
At Metronomia, we understand that your data is worth its weight in gold and as such, we ensure that your data is safe from start to finish!
„Since the foundation of METRONOMIA, we worked hard to become leaders in our field by adapting to new trends and technologies, and making the best of these available to our clients. No matter what kind of statistical challenge you have, you can rely on our experience and expert knowledge.”