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How ARC360 can help accelerate your clinical performance study

ARC360 platform

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In the ever-evolving world of precision medicine, a seismic shift in the European Union's regulatory landscape is reshaping the way we approach clinical trials. With the full implementation of the In Vitro Diagnostic Regulation (IVDR) IVD Performance Studies coming fully in to effect in May 2022, a groundbreaking transformation is underway, and its effects are now evident. It has been estimated that between 33,000 to 42,000 patients are now facing potential delays in accessing life-changing clinical trials.

In this article, ARC embarks on a journey through the regulatory changes brought by the IVDR in IVD/CDx clinical trials and recent statistics on IVDR implementation and how this has affected the clinical trial landscape. We unveil the role of cutting-edge digital regulatory tools to help navigate and accelerate clinical performance studies in the EU, US and Rest-of-World. Join us as ARC offers our industry expertise to help ease the regulatory challenges that the precision medicine industry is currently encountering.

What is the IVDR (2017/746) and what do you need to know?

As a result of the perceived need for modernisation and strengthening of device regulations, the EU published new regulations for medical devices and in vitro diagnostic medical devices in May 2017. With the complexity of changes that were required, a transition period of 5 years was set and has been in effect for in vitro diagnostics from 26th May 2022.

The absence of EUDAMED for IVD Performance Studies

The European database on medical devices (EUDAMED) is a single portal for all information relating to medical devices on the EU market and is intended to support the application for, approval of and conduct of medical device performance studies involving EU patients. Currently the platform is not fully-functional and individual member state regulations apply for performance studies which differ from country to country, provide for differing interpretation of requirements and is increasing the complexity of precision medicine trials.

While it is estimated that EUDAMED is on course to be fully functional by mid to late 2024 and potentially mid2025 before use in performance studies becomes mandatory, applications for performance studies will still be reviewed by individual member states. Until an agreed approach to study application is in place, the problems with inconsistency in reviews will persist. A recently published survey EFPIA Critical impacts of IVDR implementation on patient access to clinical trials; Survey Results 2023 conducted with various pharma companies undertaking precision medicine clinical trials in Europe found that:

  • Between 240 – 420 trials are expected to be delayed over the next 3 years
  • 33000 – 42000 patients expected to have delayed access to clinical trials (half of which are cancer patients)
  • The launch of 89 therapies could be delayed
  • Overall, companies are expecting to enroll fewer EU patients in global studies, with delays to clinical trials of 6-12 months and potentially moving enrollment sites to other territories.
  • Companies are experiencing inconsistencies across EU member states with IVDR PS application processes, review and timelines.

Source: EFPIA Critical impacts of IVDR implementation on patient access to clinical trials; Survey Results 2023

ARC360 Platform User Interface

ARC360 Regulatory Navigator - Coordinate your Clinical Performance Studies now in the absence of EUDAMED

With the implementation of IVDR and in the absence of EUDAMED it is clear that precision medicine companies need a more transparent understanding of country regulations within the EU. It can be time intensive liaising with individual country regulatory authorities attempting to understand and become familiar with their interpretation of the regulatory landscape.

In light of this, ARC Regulatory has developed a digital platform, ARC360, which provides real time information covering regulatory and safety reporting requirements for IMP/IND sponsors in jurisdictions where patients are being screened or managed.

Key features of the ARC360 platform include:

  • Access to 40+ central testing laboratory and sample collection site (clinical trial) country requirements inclusive of EU, US and RoW.
  • Regulatory & Ethics Approvals – notification/authorisation, documentation and forms required, mode of submission, typical timelines and fees.
  • Safety Reporting – requirements & definitions, responsibilities, method of reporting, forms.
  • Detailed information on Regulatory Authority Submission/ Notification requirements inc. submission format and content guidance.
  • Latest learnings and tips from our team of experts, based on their lived experience of working on study applications and managing review responses and deficiencies
  • SME support, to help accelerate you Dx study site activation and co-ordinate country start up with your trial CRO

Do not delay any further on getting your clinical development timelines back on track. Failure to comply can result in reputational damage, industry fines and additional delay to your clinical development timeline and regulatory approval.

Get in touch with ARC’s SME’s today and request a demo for ARC360. Email: [email protected] or click the link below.

Request a Demo today

Joseph Morgan
Article written by Joseph Morgan
October 13, 2023
After graduating from Ulster University with a Bachelors of Science in Business Studies with Marketing Joseph joined J&K Coaches as a Sales and Marketing Assistant before taking a role at PwC where he provided legal consulting for blue chip cl...
After graduating from Ulster University with a Bachelors of Science in Business Studies with Marketing Joseph joined J&K Coaches as a Sales and Marketing Assistant before taking a role at PwC where he provided legal consulting for blue chip clientele such as Investment banks, E-Commerce and Energy companies. During his time at PwC Joseph also gained valuable marketing experience working with both senior internal and external stakeholders developing products to fit clients’ needs. Joseph also puts his marketing expertise to use for his local community, specifically amateur theatre groups. Outside of work, Joseph is a gym regular who loves to travel and enjoys spending time with his three dogs, taking them on adventures.
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