Quality & Compliance
Safety & Vigilance
17 february 2022
Prior to recent changes, all countries within the European Union (EU) were characterised by different healthcare systems resulting in varied regulations, timelines, styles of working, and criteria needed for conducting clinical trials. With the noticeable lack of cohesion between countries, and further challenges brought by the pandemic that reduced trial activity in the EU, a ground-breaking initiative known as ‘Accelerating Clinical Trials in the EU’ (ACT EU) has been introduced. It will transform healthcare across Europe and ensure the continuing development of safe and valuable medicines.
ACT EU is designed to foster innovation and remove barriers to trial initiation, making Europe more accessible for trial sponsors. With the overall number of trials growing worldwide, the introduction of this new initiative will allow Europe to be a centre of excellence for clinical trials, offering continued extensive protection for trial participants, as well as the data transparency and robustness that is expected by EU citizens.
A key element for achieving this is already underway. ACT EU has identified the successful and timely implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014) as a priority action for 2022/2023. Under this newly implemented regulation, which came into effect on 31 January 2022, trial sponsors can make one clinical trial application (CTA) and will gain access to all participating European countries. The CTA will be processed through the Clinical Trial Information System (CTIS) allowing for a simpler, more streamlined evaluative process. Previous lack of process harmonisation, variable costs, and the impact of Covid-19 had led to sponsors favouring non-European countries as a more suitable choice of location.
PLG helps clients to navigate the new CTA process via CTIS
PLG ensures that our clients are compliant with the EU-CTR, offering the services needed to support every stage of the trial. With a diverse team of experts, PLG can assist clients in managing CTA activity through the CTIS, managing end-to-end safety reporting activities, as well as offering standardisation in work quality to ensure the utmost compliance to the new EU CTR.
As part of the CTA support we provide, PLG’s local experts advise sponsors on the choice of reporting member state to avoid any unfavourable opinions that could negatively impact outcomes in member states concerned. PLG also offers support in CTA submission related services like drafting IB, IMPD, lay person summaries, PIP and redaction of confidential documents, as well as designing regulatory non-clinical/clinical development plans, and offering quality, regulatory expertise and guidance to both clients and CROs who wish to understand more about the new regulations.
In addition, the transition from the EU directive to the new regulations could significantly affect timelines, impacting the success of a project at large. PLG offers structured, well-planned strategies that can assist clients through critical milestones to reduce delays or additional costs.
PLG offers a ‘one-stop solution’ for clients by providing a range of valuable in-house services and much-needed expertise that can fast-track clinical trials all while providing outstanding support to clients. For many CROs and pharma organizations who collaborate with PLG from the onset, we are a first point of contact, aligning with the EU’s ‘open for business’ strategy to support clients from start to finish.
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