We support you in developing the optimal clinical study strategy tailored to your specific needs. Our services include cost optimisation, reducing time to market, and study planning based on the required clinical data. With practical solutions and valuable insights, we ensure that your clinical studies are conducted safely and cost-efficiently, with patient safety always at the forefront, ensuring the success of your product in the market.
Our consulting services at a glance
Strategic Workshop for Your Individual Needs
We work with you in a workshop to develop the essential foundations for defining the next steps towards achieving your goals. Based on this collaboration, we create clear strategies and tailored solutions embedded in a detailed timeline with clear responsibilities to ensure successful implementation.
Market Entry Strategy
We develop a strategy tailored to the specific requirements of your clinical study, including compliance with regulatory standards and the selection of appropriate target markets. Our support includes optimizing the study protocol to accelerate the approval process while proactively addressing potential obstacles at an early stage.
Cost Optimization
We support you in designing your clinical investigation, focusing on cost efficiency. Our services include budget planning and monitoring, negotiating optimal contract terms with service providers, and optimizing study workflows. By effectively utilizing resources, we ensure the optimal use of available funds.
Identification of Clinical Data Gaps
Our Clinical and Scientific Affairs team supports you in identifying clinical data gaps through the creation or review of the clinical evaluation plan. This allows the identification of any missing data necessary for the successful market entry of your medical device. This analysis serves as the foundation for the subsequent clinical study planning.
Feasibility Assessment
A comprehensive feasibility assessment is essential before initiating a study. We analyse potential sites, develop patient recruitment strategies, and assist with logistical planning. Potential challenges are identified early, and we proactively establish measures to address them.
Study Design
We develop customized clinical study designs tailored to your specific goals and regulatory requirements. This includes selecting appropriate endpoints, determining the correct sample size, and choosing the right methodology to generate meaningful results. Our goal is to establish a solid foundation for study's success and optimally prepare for the approval process.
How Can We Help You?
Take advantage of our expertise and work with us to make your clinical study successful.
Contact us today to find out more about how we can help you.
Bernhard Bichsel
Co-CEO
Julie Tantau
Head of Clinical Operations
©
2024
ISS AG, Integrated Scientific Services