The landscape of clinical trials is undergoing a profound transformation. On one hand, regulatory changes such as the full implementation of the Clinical Trials Regulation (CTR) in the European Union (EU) aim to streamline processes and enhance transparency. On the other, digital technologies, like Sqilline’s “Find More” application within Danny Platform, is making clinical trial discovery, feasibility studies, and patient recruitment more efficient than ever.

Together, these advancements are accelerating the progress of medical research – making it faster, more efficient, more transparent, and more accessible to patients.

The impact of the Clinical Trials Regulation (CTR)

As of January 31, 2025, all clinical trials in the EU are governed by the Clinical Trials Regulation (CTR). This marks a major milestone in clinical research, bringing an end to the three-year transition period from the former Clinical Trials Directive (CTD). More than 5,000 clinical trials have successfully transitioned to the CTR framework via the Clinical Trials Information System (CTIS) – a single-entry platform designed to streamline submissions, approvals, and oversight across the EU. Several key features mark the CTR implementation.[1]

Unified system for trial applications and standardized procedures across the EU

CTIS serves as a centralized portal where sponsors submit trial applications, ensuring a consistent process across EU Member States. Clinical trial sponsors now follow a harmonized application process, regardless of their location or the national competent authority overseeing their trial.

Greater transparency and consistency

CTIS provides a publicly accessible database, allowing healthcare professionals, patients, and the public to search and access trial information. This initiative not only boosts trust in clinical research but also ensures that all sponsors, follow the same procedures when applying for trial authorizations in the EU.

Stronger regulatory oversight and harmonization

The CTR simplifies the regulatory process by ensuring that every trial is processed under a consistent set of guidelines. While trial authorization remains under the jurisdiction of individual EU/EEA Member States, the European Medicines Agency (EMA) ensures the smooth operation of CTIS, and the European Commission oversees compliance with CTR guidelines.

All these improvements are further supported by the Accelerating Clinical Trials in the EU (ACT EU) initiative, a collaboration between regulators to transform how trials are designed and conducted in the EU.

“Find More” bridges the gap with innovation

While regulatory changes are streamlining clinical trial processes, innovative technologies are key to ensure efficiency in trial execution. Recognizing this need, Sqilline Health, a leading health-tech company, has developed “Find More” – an advanced application within the Danny Platform – to empower investigators, sponsors, and clinical sites in finding and enrolling eligible patients. How is “Find More” transforming clinical trial recruitment?

Integration with leading clinical trial registries

Investigators can access real-time data from ClinicalTrials.gov and Clinical Trials Register EU, eliminating the need for manual searches. This seamless integration enables sponsors to stay informed about global research opportunities and take faster important strategic decisions.

EHR integration for streamlined patient recruitment

Automatic integration with electronic health records (EHR) allows investigators to quickly filter and match eligible patients to clinical trials based on medical history and demographics. A user-friendly dashboard consolidates all necessary data, ensuring user-friendly navigation through patient records and study criteria. This increases efficiency and return on investment leading to 40% reduction in investigator’s time spent on searching eligible patients for clinical trials and faster patient enrolment.

Interactive map for trial discovery

A dynamic, country-specific map displays the geographical distribution of ongoing trials, making it easier for investigators to find active studies in their area. This feature accelerates patient recruitment, ensuring trials reach their required enrolment targets efficiently.

By combining automation, real-time data access, and AI-powered patient discovery, “Find More” significantly improves efficiency, accuracy, and accessibility in clinical trial recruitment.

The synergy between regulation and innovation

The convergence of regulatory advancements (CTR) and technological innovations (“Find More”) is reshaping the future of clinical research. Here’s how they complement each other:

This dual transformation ensures that clinical trials are not only compliant with new regulations but also optimized for speed, quality, and accessibility.

The data-driven, patient-centric approach in clinical research

The shift towards data-driven, patient-centric clinical trials is gaining momentum. With tools like “Find More” and regulatory frameworks like CTR, the focus is now on:

• Faster trial recruitment, reducing delays and improving access to groundbreaking treatments.
• More diverse patient participation, ensuring broader representation in medical research.
• Greater trial transparency, building trust between patients, researchers, and regulatory bodies.
• Efficient resource utilization, optimizing trial management for sponsors and sites.

As clinical trial regulations evolve, technology must support key stakeholders in this process. Sqilline’s Danny Platform and “Find More” application provide the innovative tools needed to make clinical trials more efficient, inclusive, and impactful – ultimately improving patient outcomes and medical advancements.

To learn more about how Sqilline Health’s innovative solutions can help you navigate the evolving landscape of clinical trials, visit our website, or contact our team today.

[1] EMA: Clinical Trials Regulation becomes fully applicable, 31 January 2025