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Industry CTR Readiness

Responses from the CTIS Webinar - Ready or not 

Deloitte-Iperion recently held a webinar exploring some of the challenges Industry will face when preparing for and operating under the new Clinical Trial Regulation and Clinical Trial Information System (CTIS). During the webinar we surveyed the audience to understand where representatives from Industry felt they were on the scale of preparedness and where some of their concerns truly lie. If you too are preparing but could not make the webinar the results of the survey will be of interest.

By Stijn van den Berkmortel, Paulien Nuyts and Sebastian Payne

Background

Deloitte-Iperion recently held a webinar exploring some of the challenges Industry will face when preparing for and operating under the new Clinical Trial Regulation and Clinical Trial Information System (CTIS). During the webinar we surveyed the audience to understand where representatives from Industry felt they were on the scale of preparedness and where some of their concerns truly lie. If you too are preparing but could not make the webinar the results of the survey will be of interest.

With Industry representing nearly three-fourths of attendees the survey reveals a good indication of their readiness for CTR/CTIS (see Figure 1).

CTR/CTIS Readiness

With the go-live of CTIS only 4 months away a fifth said they were feeling pretty good about being ready and half believed that they would be OK in terms of readiness (see Figure 2). However, it is important to note that no one was so confident to state they were “Supremely” confident with 17% being worried and 11% having apparently not really started.

In further feedback there has been a real concern from Industry about the Sandbox being only scheduled to be available 2-3 months before go-live. This could explain to some degree why there is not the confidence in preparedness there might otherwise be.

Interestingly, nearly a third of organisations expected to prepare themselves with only internal resources with half already or expecting to make use of Consultancy and/or CRO support (Figure 3). Just under a quarter didn’t know how they would approach getting ready. It is likely that these representatives would also be in the 28% that where worried or have not started to prepare.

Submissions under CTR/CTIS

As one might expect there is a correlation between the level of confidence about being ready to submit and the expected timelines of when organisations expect to start submitting within CTIS. Just under one fifth of those surveyed were expecting to submit trials within CTR from the go-live date with just under a half expecting to submit trials in the first transition year period and just under a quarter expecting only be ready to submit at the end of the 1st year of transition (Figure 4). Fortunately, no one stated that they would not be ready, the consequence of which would be that they could not make applications to run trials within the EU.

Biggest challenges

Finally when questioned on what the organisations saw as the biggest challenge (out of those discussed in the webinar) nearly 40% were most concerned about the application procedures and timelines, reflecting the strain that will be placed on organisations internal workflows and re-organisation required to meet the strict timeline constraints the regulation and it’s systems enforce (see Figure 5). The next concern which almost 1/3rd voted for was Transparency. From conversations with clients we believe much of the concern here lies around optimising the deferral strategy across the different types of documents. 24% indicated Submission Strategy was a concern and this can probably be traced to concerns on optimising the internal workflow and organisation but also probably around concerns on getting the RMS proposed and that parallel submissions to multi-member States are not possible. User Administration only received 7% but that is also likely because Submission, procedures and timelines dominate the field of concern. It is likely that there will need to be experimentation but organisations to setup their optimal user administration throughout the first year that CTIS is live.

Final remarks

We would like to extend our thanks to those who attended the webinar and answered the survey questions. If you have any questions or your own concerns as we move into the last few months until go-live, please do not hesitate to reach out.

How can Deloitte support you?

We have extensive experience in supporting regulators and top pharmaceutical companies to prepare for new Life Science Regulations, and since 2014 we have been helping organisations prepare for the implementation of the Clinical Trial Regulation. We are skilled with differentiating and setting up regulatory frameworks in challenging and diverse jurisdictions. We pride ourselves in supporting organisations in defining and executing optimal strategies for CTR implementation and ensuring they are and remain responsible businesses. Want to know more? Find our contact details below.

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