The right insights help deliver the right outcomes.
Biostatistics encompasses science and operation activities required to summarize and analyze the data collected in clinical research and investigations. Biostatistics is used to interpret and draw inferences from data collected on clinical investigations and performance studies as they progress through a study and serves as the bridge between data capture and reporting.
The Medical Device Regulation 2017/745 and In Vitro Diagnostic Medical Device Regulation 2017/746, set as an amendment to EU Directives 93/42/EEC, 90/385/EEC, and ISO 14155:2020 and 20916:2019 has put a stronger emphasis on statistical justifications, and this is something manufacturers with medical devices looking to enter the European Market needs to comply with.
AKRN partners with MedTech companies as a scientific consultant to develop clinical documentation with a comprehensive design, where deep expertise can help design better outcomes.
Our biostatistics team is specialized in creating accurate and suitable strategies.
- Definition of Study Endpoints, Objectives and Variables.
- Development of Statistical Analysis Plan
- Analysis Population
- Sample Size Calculation
- Comparative and Descriptive Analysis
- Interim Analysis
- Development of Justifications and Rationales
- Preparation of Plans and Procedures