In the IVD world, market success depends on scientific credibility. To be successful, a product must prove itself to regulators, payers, and physicians.
The foundations of scientific proof are robust clinical trial design and effective representation of results. Myraqa’s capacity in biostatistics and trial design is simply without peer in this industry.
Success in clinical also takes skillful execution, including monitoring and coordination expertise. Done well, clinical execution is a critical element of assuring data integrity.
Clinical trials are very lengthy and expensive. There is possibly nothing worse than conducting a long, expensive trial and discovering that it was not designed correctly for what it attempted to prove.
There is no one-size-fits-all trial design. For novel or challenging products it pays to meet with FDA and other stakeholders early in the process.
The benefits of early input must be weighed against other factors. It is only beneficial to approach FDA once you have important questions that only they can answer.
Determining the best approach to clinical trials will include addressing a number of questions, such as:
- What are the relevant clinical decision or cut-off points for this indication?
- How will the performance of the product affect study design?
- How will choice of study subjects change what we will be able to claim later?