Anders Mortin, co-founder of consulting company TriTiCon looks at the three key steps for start-ups and growing companies wanting to maximise the value of trial data.
Health Data
In the early stages of starting a company or with a new product in the pipeline, the focus is primarily on trial execution. And of course, execution is important. However, it is the accumulated data that matters in the end as it is the evidence revealing the value of your product and also determining future funding, partnering or out-licensing of the product in the developmental stage. It is furthermore the foundation for a future submission. From a regulatory perspective, you, as the sponsor, have a responsibility to ensure that the data is accurately recorded and reported, even if you fully outsource your trials.
Ensure standards compliance for your data
The simple advice? Follow CDSIC standards. The standards from the Clinical Data Interchange Standards Consortium (CDISC) are not only a technical data concept for data specialists, but also a best practice, quality and compliance driver for CRF design and data collection alongside being an expectation from the FDA for how data is submitted in the end.