Support areas
At StatisticaMedica we offer innovative and effective approaches to design and implement studies that give clear measurable answers to concrete questions in the most cost-effective way.
Biostatistics and Epidemiology
- Design of clinical trials, observational studies and lab research.
- Analysis of health data from bench to patient population.
- Development of statistical methods.
- Statistical Programming.
Data Management and Bioinformatics
- Electronic Data Capture, data quality audit, Database programming
- Genomics and Proteomics data analysis for biomarkers and diagnostics
Full Trial Services
- We are Preferred Vendor to ICON Clinical Research for biostatistical support.
- We partner with ICON Clinical Research to provide the full suite of trial services, including project management, study coordination, recruitment, monitoring and ethical approval.
Regulatory and Clinical Development Strategies
- Regulatory submissions for EU MDR: strategies on how to maximize the clinical evidence you have and minimize the need for the evidence you do not have.
- High quality, targeted, regulatory-grade biostatistics to accelerate the interaction with the Notified Bodies
Where we help?
Type of study, type of measurements and data collection process, assessment schedule and logistic for good quality data
Rational for sample size and sampling strategies, randomization schedule, development of data collection tools and statistical analysis plans
Collaboration with Subject Matter Experts in many therapeutic areas to address the clinical challenges of of the design and implementation of health studies in Europe and overseas
Support in the preparation of all regulatory documents and assistance in the interaction with regulatory agencies
Design of CRFs and all data collection instruments, Database Design
Analysis of data from small and large samples, addressing complexities such as ‘omics’ data, large scale datasets, lab data as well as registry, medical records, surveys
Assistance in the design and implementation of QC and QA processes, compliance procedures and database quality audit
Generation of statistical reports, assistance in integration of statistical results into reports such as ethical/regulatory submissions, full clinical study report, manuscripts, policy documents and grant proposals
Markets we address
StatisticaMedica works in the translational space between research and business, with clients in
Academia
Food Industry
Medical Device Industry
Pharmaceutical Industry
Medical Device Industry
Research Hospitals
Public And Private
Research Institutes
The added value: Synergy
By being exposed to clinical research, public health, biomedical research, bioengineering, nutrition and health care research, we have created a synergistic added-value for our clients:
The practices and standards of this industry are extremely high and constantly adapting to new needs in the market. They require rigorous methods, robust evidence and effective use of resources. We at StatisticaMedica meet them constantly with hard work and dedication.
During this process we acquire new knowledge that is transferable to all our projects. We strive to adapt the industry practices and standards to the translational research environment and the academic research sector so that those studies also will show robust evidence and rigorous methods . This approach increases the quality of the outputs and their transferability to patient-oriented results. It helps to advance the development of new therapy protocols, innovation in diagnostics and medical devices, the delivery of strategic and effective policy documents and the improvement in practices for patient care.
Via our network of collaborations in academia and research institutes worldwide, we work in the high-end segment of medical statistics, acquiring new knowledge on the most innovative and rigorous statistical methods for data analysis, modelling and data collection. We strive to transfer these valuable tools to the industry projects to make the clinical development more effective and shorter. This reduces cost and resources, increases commercialization and minimizes patient’s time.