Published on October 05, 2020

The following is an excerpt from our free whitepaper ‘Satisfying PMCF requirements by utilizing IIS data’. Click here to download your copy.


It has been estimated that 85% of the millions of dollars spent on clinical research fails to be useful; however, there is an increasing mandate for clinical data to help inform meaningful, pragmatic approaches to disease management. The costs associated with conducting clinical trials to generate new insights is often too high when compared to the slim returns, especially in terms of quality of the clinical data collected (Ioannidis J 2016). Yet maximizing the quality and variety of clinical data collection is a medical necessity, and a desirable business objective.

In general, the medical device industry spends hundreds of millions on Investigator Initiated Studies (IIS) or External Research Programs (ERP) each year, but there is limited quality control, monitoring and/or reuse of data generated in these studies. Studies focused on the “Value for Money” perspective on clinical trials indicate that 90% of the expenditures on these trials could be saved as inconclusive and inefficient (Ioannidis J 2016). A common failure is that investigators use tools not suited for data capture in a clinical study, for example, MS Excel or SPSS, rendering those projects non-compliant with GCP and 21 CFR Part 11. Furthermore, sponsors often have limited return on investment from IIS projects because they have little insight or control into how and when these projects produce a deliverable that adds value for their business.

To help resolve these challenges we propose a solution in which data generated through IIS will be of higher quality and should satisfy regulatory requirements for medical research such as those outlined in GCP and the MDR. Furthermore, our solution can maximize the impact of these IIS data for the investigator through successful scientific publications, and the sponsor through real-time progress reports and reuse of anonymous study data. The latter is particularly valuable in the context of the EU MDR, where substantially more Post-Market Clinical Follow-up (PMCF) data will be required to keep devices on the market.


Find out about Castor’s solution in the full whitepaper, ‘Satisfying PMCF requirements by utilizing IIS data.’

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