CTIS Webinar responses: Ready or not

Deloitte-Iperion held a webinar on 20 September 2021, exploring some of the challenges Industry will face when preparing for and operating under the new Clinical Trial Regulation (CTR) 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.

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

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Figure 1. Overview of the types of organizations

 

CTR/CTIS Readiness

With the go-live of CTIS only 4 months away – at the time – 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.

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Figure 2. Responses to the question: ‘How confident are you of your current level of readiness for CTR?’

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 organizations 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.

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Figure 3. Responses to the question: ‘How do you expect to get ready for CTR/CTIS?’

 

Submissions under CTR/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.

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Figure 4. Responses to the question: ‘If you will submit trials through CTIS/CTR will you think you will be ready to do so from?’

 

Biggest challenges

Finally when questioned on what the organizations 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 organizations’ internal workflows and re-organization required to meet the strict timeline constraints the regulation and its 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 optimizing 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 optimizing the internal workflow and organization 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 organizations have to set up their optimal user administration throughout the first year that CTIS is live.

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Figure 5. Responses to the question: ‘Of the challenges discussed what was/is your biggest concern?’

 

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 days until go-live, please do not hesitate to reach out.

The recording of the CTIS webinar can be found here.

 

by Sebastian Payne

A Director at Deloitte, leading a team of Life Science specialists and focusing in Life Science Risk Advisory with over 20 years of experience in LSHC consultancy. Assisting organizations with insight and strategy delivery, in the face of significant Life Science regulatory and technological change.

 

This article was originally published as a blog on the Deloitte website.

Our knowledge and experience on CTR has grown extensively, when we joined Deloitte in May 2021. We are helping regulators and pharmaceutical companies to prepare. And we pride ourselves in supporting organizations in defining and executing optimal strategies for CTR implementation. Do you want to know more, please reach out to Sebastian Payne or via the form below.

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