EU CTR Implementation Support

You may have been trained or read the Regulation back in 2014 when it was issued, but a lot has happened since then, be it the Clinical Trials Information System (CTIS) or several implementation guidance texts.

Beyond these documents, the framework of the implementation is now clearer, requiring companies to evaluate their gap with current practices and decide on their implementation strategy. From Management to Operations, the first step is to raise internal awareness around all these aspects.

We have developed several training modules to address the various needs of our clients (see the list below). They can be delivered in-house by one of our EU CTR experts, and they include quizzes, Q&A sessions and use cases.

Special needs can also be evaluated, and presentations can be tailored for you. Do not hesitate to reach out to ObelysQ to discuss how we can help you train your staff for the EU CTR.

• Module 1: Overview of the CTR 536/2014
• Module 2: Focus on CTA submissions
• Module 3: Focus on new concepts of the CTR
• Module 4: Focus on Transparency
• Module 5: Focus on CTIS
• Module 6: Focus on CTR implementation strategy and related organizational changes

Why not start with an e-learning session? We have created a shorter version of Module 1 in that format to facilitate deployment to a larger or geographically spread-out group. With our e-learning “Overview of the CTR 536/2014” you can establish a baseline of knowledge for all relevant stakeholders.

Please find more information on the content of our e-learning session here

Following the awareness training, or if you have already reached that step, comes the detailed planning for implementation. 

During that phase, we will accompany your teams to cover the following steps:

• Review the company’s CTA portfolio of impacted trials as well as review planned CTAs. This is a key milestone to evaluate the magnitude of the effort required, establish priorities and start considering the implementation strategy.
• Gap analysis of the CTA SOP landscape (just limited to CTA, or including serious breaches, etc…). This will allow us to evaluate and quantify the need for new processes and SOPs necessary to describe the new activities.
• Support the definition of a company vision/approach for implementation: is it better to adopt an early implementer profile or not? What are the pros and cons?
• Create a plan for future CTAs and conversion plan for existing portfolio, as well as discuss the results from the SOP gap analysis. At the end of this phase, we will have defined the way forward, established the priorities and considered the risks. The result will be collated in a report and a slide deck to facilitate internal communication and decision making.

We can also support you in delivering your implementation of the CTR 536/2014, (whether previously involved or not), in the following manner:

• Create and/or update impacted SOPs or Working Practice documents and define organization new roles and responsibilities mandated by the new legislation.
• Deliver internal trainings on new processes.
• Support your teams during initial clinical trial submissions and transfers.
• Accompany your teams throughout the change
• Create or support an already existing CTA task force.

If you are running a lean organization in Europe, we can establish together a longer-term support, where we can be delegated a number of tasks, such as:

• Continuous regulatory intelligence. What are the new implementing guidance or delegated acts, new country specific requirements and how to interpret them in your situation.
• Effectiveness check, in order to ensure true compliance with new or modified processes.
• Handling of routine CTA submissions and CTA transfers until the end of the transition period.

These services and trainings have been prepared in collaboration with Fabien Peuvrelle from Intagest Consulting Solutions (Barcelona, Spain). Holder of a Pharm.D and of a Law degree in Regulatory Affairs, Fabien boasts 25 years of regulatory affairs experience in the pharmaceutical industry, in companies like Novartis and Celgene, and is a Senior Consultant at Intagest since 2018. Involved as subject matter expert for the Pharmaceutical Industry during the Clinical Trials Regulation discussions in the EU Parliament, and later in the early stages of the development of the CTIS, he has been keeping a close eye on the developments that led to the coming into force of the Regulation on Jan 31st, 2022.

Should you require to have all your staff trained on the EU CTR, ObelysQ can offer to create a dedicated environment in our electronic Learning Management System, where you will be able to assign relevant modules to your staff, track training progress, and document training completion.