The foundation of Key2Compliance’s services is to provide customer-oriented solutions that can solve any need of our clients. As an important part of our Clinical Development area, our Biometrics group work with data to provide important insights. Not only to prove that a pharmaceutical or medical device is safe and efficient, but to ensure regulatory compliance and hopefully success.
The Key2Compliance’s Biometrics group consists of experts with diverse backgrounds. This gives the team the unique ability to provide both single service assistance, such as designing the study and choosing the right data capture tool, to analysing and presenting data – from the project’s start to finish. All done with a deep understanding of the regulations and needs concerning medical device and pharmaceutical companies. This is how our Key2Compliance’s Biometrics group work to help our clients use data as a tool for success.
Data are so much more than just what’s required to reach compliance. The biostatisticians, statistical programmers and data managers of Key2Compliance’s Biometrics group use data to provide insights regarding the safety and efficacy of their product. When the clinical data is collected, analysed, and reported in a correct and fully operative way, the complex road from idea to market becomes much simpler. The client’s main focus should be on making the best product possible, and Biometrics’ mission is to collect the data to support that.
As a part of Key2Compliance’s customer-oriented services, the Biometrics group can support clients on an hourly basis, if the client has no need for full service. If a client just needs help with collecting data, the group will help with that. If the client’s only requirement is a database for the collection of data, the group will help with that as well. The Biometrics group can do the complete process from designing the entire study to providing the report to the regulatory authorities and ethics committees. In the end the goal is the same: to obtain the data the client needs support their products´ claims.
Key2Compliance’s Biometrics group consists of biostatisticians that are involved early in the study design phase involving endpoint definition, sample size calculation, as well as how the data should be analysed. This results in a statistical analysis plan which is the basis for the data analysis. The data managers set up a platform for collecting and managing data during the study, while also making sure that the data collected is of high quality and sufficient to answer the study objectives. The statistical programmers functions as the link between the statistician and the data manager, supporting the programming of tables, listings and figures. The Biometrics group work with statistical analysis software (SAS) recognised in the industry and follow harmonised data standards when needed (CDISC).
The members of the Biometrics group come from several different areas of the industry, including the CRO and sponsor side. This gives the team a unique expertise when working with the clients. As Albana Shahini, Senior Consultant Clinical Development/Biometrics Team Lead and data manager within the Biometrics team, puts it: “We have varied backgrounds from pharmaceutical and medical device companies, consulting companies, clients etc. This gives us perspectives from all sides. Key2Compliance also has an overall experience and expertise of the Medical Devices area, which means that we can really understand that industry. With the MDR, we have noticed an increase in the need of producing supporting data for the device claims and not only for new devices but also for devices already on the market. A clinical evaluation of the device can many times require a clinical investigation which many manufacturers have never done before MDR. The mission for our Biometrics group is to guide our clients into performing a data collection and analysis in the right way with high quality. We understand their area and their challenges and can tailor the activities needed for the data collection and analysis using a risk-based approach where the client is involved along the whole process.”
Involving the Biometrics group early in the study design process will lead to the most efficient data collection and statistical analysis processes. Which in turn will support the client’s product development, making the complex easier so the client can focus on turning their ideas into marketed products. No matter if they need a little help along the way, or a complete solution, the Biometrics group is there to assist.
Find out more about our Clinical Development area.
