The end of CTIS transition period - 5 key areas sponsors should prepare for

Change is what makes us push boundaries. As our medicines keep evolving, so do Clinical Trial procedures.

31st January 2022 marked the start of the transition period that changes the way we submit, authorize, and supervise CTAs. By 31st January 2023 both the Member States (MS) and sponsors would have needed to start handling any initial CTs on the online centralized system.

All from a centralized single point.

As per the new CTR, sponsors now submit their applications through the Clinical Trials online site. No more fragmented multinational CT applications and complex submission frameworks. Existing CTs and their results can be found in one place and sponsors can directly communicate with MS about any ongoing trials.

Overall, CTIS provides a safer, more precise and efficient utilization of the products that are potentially being placed on the market. Higher transparency, co-ordination and promptness are the 3 major benefits that are lowering costs, producing more credible data and making the EU a more attractive location to conduct CTs.

As the way we handle CTs changes, sponsors’ workflows and procedures change accordingly.

Marti Farm’s extensive experience in handling changes and managing Clinical Trials creates insight in the areas sponsors must keep in mind before using CTIS. Now we are ready to share them with you.

Here are 5 key tips sponsors or relevant organizations should do to prepare for the new CTR.

Delegate CTIS duties to multiple people

The key to successfully adapting to new sets of procedures within CTR is to have in-house experts on the system.

Create an all-hands-on deck team. They will absorb all CTIS information and make it more accessible to the rest of the team. It’s important to have at least two people to learn all of the different aspects of CTR.

And trust us, there is a lot of information.

Separate the team of experts into several roles. This may be by specific areas of CTIS, or by role within the team such as main point of contact and educator.

Take a look at your team. Who has the most experience in implementing changes? Who is seen as the natural mentor of the group? Who is everyone most comfortable with to ask for support?

These members would be the point of contact for everybody to ask relevant questions and to offer support to their colleagues. This could be in the form of timeline infographics (see below), trainings, meetings or as simple as pointing them in the right direction.

You can find all official materials available here: Sponsor Training and Support and EMA’s YouTube channel. These range from handbooks, timeline details, YouTube videos all the way to training environments and sponsor organisation models.

The delegated members would go through all materials, become the expert themselves, and then share that knowledge with the rest of the team.

Co-ordinate ongoing trials with start date

Although transition period ends on the 31st January 2023, sponsors have until the 31st January 2025 to start managing all, initial and ongoing, trials. During those 2 years, you’ll only have to submit new applications through the new system.

That means that if you have an ongoing trial that is shorter-term and will end by 2025, using the older directive is perfectly reasonable.

Make sure you take advantage of this period. Select a few pilot trials to test the CTR and new system. Be prepared to make mistakes. Prioritize which trials you wish to manage through CTIS and which through the older directive. This is what the transition period is for.

Most importantly, you want to encourage using the new CTR during this period. The more you prolong the transition within your team, the harder it will be for them to work it out once the final deadline approaches. Marti Farm eases the pains of transitioning. Our CT services include managing all duties regarding CTIS. We can submit your studies for your and carry out all Pharmacovigilance activities needed. Delegate the role to us as a CRO and your CT activities will be made compliant and up to date.

 

Create new systems to meet new deadlines

With CTIS comes a new set of rules in answering application queries or requests for information (RFI). From the day the RFI is sent out, sponsors now have a maximum of 12 calendar days to respond otherwise their application will automatically lapse.

Remember, the intention behind CTIS is to make the EU an attractive location for conducting trials. And competitive timelines help us get closer to that goal. Tighter timelines make Clinical Trials more transparent, reliable, and shorter than before. That is what’s going to put the EU ahead of other regions.

All initial applications and modifications must be monitored closely. The worst thing that can happen is that there is a query waiting for you that nobody seemed to notice.

Create a Rapid Response Team. This team’s responsibility will be solely on answering queries on time as well as making sure everybody is meeting deadlines. They could implement external tools such as interactive calendars that remind the team of upcoming deadlines.

All activities must be streamlined to avoid bumpy workflows. Therefore, sponsors must create tight processes that are perfectly coordinated with all other contributors, such as CROs.

To create synergy, Clinical Trial contributors should plan ahead to manage each stage of the trial and oversee the time permitted to spend on each step. Once all activities are mapped out, contributors may also assume foreseeable challenges and give extra time on such activities accordingly.

Beware of the public eye

There is a new stakeholder that will have access to the CTIS site, the public.

We are used to CT data being broadcasted only at the product authorization stage. The new regulation, however, wishes to increase the transparency further. CTR makes data publicly available throughout the whole development process.

The addition of the public increases exposure on those organizations that do a poor job in maintaining ethical and high-quality clinical trials.

This means that the pressure is on for sponsors to follow tighter deadlines, the responsibility of reporting and patient safety regulations to a T.

Otherwise, the mistakes are widely exposed and can negatively affect both the sponsor’s and the study’s credibility and GCP status.

A list of information that will remain private includes:

  • Information related to GDPR, Quality, Company Confidential Info (CCI)
  • Assessment report drafts
  • Documents labelled ‘not for publication’
  • Financial agreements

To avoid negative exposure sponsors must pay close attention to the way they act on any Adverse Events (AE) during the trials.

In addition, they must also carefully decide on which details they want to leave out of publication. It is their responsibility to protect the patients and their privacy before publishing anything to CTIS.

So how can you ensure no mistakes have been made? Consistently check, double-check and even triple-check each other’s work.

From our experience, having multiple workflow stages for reviewal is the best way to prevent all inconsistencies along the way. The reports should be modified and commented on at each stage to avoid negative findings from the RA or public.

Multinational applications – choose the reporting country carefully

With CTIS comes a co-ordinated approach to Clinical Trial Application assessment. Multinational applications will now be led by one single Reporting Member State (RMS).

The good news is that you won’t have to require approval for each country and their separate regulations. Your time working on all those applications and waiting for their review will be cut in half. The bad news is that if the chosen reporting country decides to reject your application, all the other Member States will automatically reject it as well.

You have the right to first choose who you want to delegate as your RMS. The chosen Member State carries a lot of responsibility on their shoulders. In the end they decide whether your application is approved or rejected.

Make your first-choice count.

Think about all the Member States with whom you had already applied your Clinical Trial to. Can you think of a favourite?

If you can, why not try working with them again? The fact that you had no issues with their regulatory systems and requirements in the past, means you most likely won’t have issues this time. That increases the chances of having your CT approved once again.

After you’ve picked your RMS, all MS then have to agree on which state will be the actual RMS.

Why wouldn’t your chosen RMS be the actual RMS?

Per CTR, after a sponsor chooses its desired RMS, all Member States have 6 days to communicate amongst themselves in case:

  1. The desired RMS does not wish to be the RMS
  2. The desired RMS is the only MS that wishes to be the RMS
  3. There is one or more other MS that wish to be the RMS
  4. No MS wishes to be the RMS
Choosing a reporting member state on CTIS timeline infographic

If they cannot provide the sponsor with an answer by day 6, the MS the sponsor chose in their application is deemed the RMS.

If you cannot think of one Member State that you would like to work with, let us help you.

Marti Farm provides insight of each country’s regulatory systems and rules. We determine the country that has the most effective way of communication and share it with you. Together we can ensure that the reporting country chosen is the most successful option for your multinational Clinical Trial application.

It is important that we not only accept changes but also that we understand them. CTIS brings new opportunities for sponsors and creates a harmonized approach to Clinical Trials. Most importantly, once sponsors settle into the new systems of CTR, they will notice the promptness and ease of reviews, approval and communication with regulatory bodies.

As we prepare to bring Europe ahead of its competitors with the new CTR, we come to find specific regions that come with its own unique set of benefits. Find out why sponsors have been choosing Eastern Europe for conducting Clinical Trials lately by reading our previous blog.

Marti Farm has extensive experience in implementing changes and supporting organizations navigate through major transitions. For full-support services in Clinical Trials or any further inquiries, contact us at bd@martifarm.com.

Zahida Drače, dr.sc. / Project Manager in Clinical Trials

Dunia Mando, bacc.oec. / Digital Marketing Specialist and BD Associate

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Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Planinska ulica 13, HR 10000 Zagreb
Office: Planinska ulica 13, HR 10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121

OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)

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