with a tailored clinical evidence strategy and biostatistics services
If you are a small-to-medium-sized MedTech company (or startup), you need a clinical evidence strategy from the early stages:
Product Development: Early clinical evidence helps shape the product’s design and features, ensuring it meets real clinical needs and avoiding costly redesign.
Regulatory Compliance: Medical devices and software as medical devices (SaMD) must meet strict regulatory requirements. A robust clinical evidence strategy helps ensure compliance with guidelines set by regulatory bodies like the TGA, FDA or EU MDR.
Attracting Investors: A well-thought-out clinical evidence strategy demonstrates to potential investors that the startup understands the regulatory landscape and has a clear path to market.
Competitive Advantage: Strong clinical evidence can differentiate your product in a crowded market, showing how it outperforms existing solutions or fills an unmet need.
Continuous Improvement: An ongoing clinical evidence strategy allows for post-market surveillance, enabling continuous refinement and improvement of your MedTech innovation.
A robust clinical evidence strategy requires a combination of biomedical knowledge, statistical expertise and a strong understanding of regulatory requirements for clinical evidence.
Precision Statistics is an Australian-owned boutique MedTech consultancy specialising in clinical evidence and biostatistics services for medical devices and software as medical devices (SaMD).
We are experienced clinical researchers, biostatisticians, health data scientists and medical writers. We take a partnership approach to create a tailored solution for the clinical evidence needs of your MedTech innovation.
Assess existing clinical evidence in a systematic and unbiased manner for your evidence generation needs.
Expedite and optimize the chances of success of your clinical trial and submission to regulatory authorities.
Leverage real-world data (RWD) to assess the effectiveness, safety and value of your medical technology products.
Empower your team with the skills to conduct statistical analysis and interpret clinical evidence.
