Aurevia CRO and QARA Services

20/10/2026

Your partner for oncology clinical trials
Oncology trials are complex—scientifically, operationally, and from a regulatory perspective.

Our teams have both deep knowledge and hands on experience, supporting oncology clinical studies across multiple indications and development phases, often in multinational and multi site settings.

At Aurevia, we work alongside biotech, pharma, medtech, and academic teams to support oncology trials across Europe.
With integrated clinical and regulatory expertise, we help navigate complexity — from study design and regulatory strategy to clinical ex*****on — always with a focus on quality, compliance, and patient safety.

Our goal is simple: to help you move your oncology program forward, efficiently and confidently.

Curious how we can support your next study? Learn more and contact us so we can discuss your needs: https://eu1.hubs.ly/H0zdtRR0

19/10/2026

Aurevia brings together expertise across clinical research, quality assurance, and regulatory affairs, helping life science companies navigate complex challenges across the product lifecycle.

Want to stay connected with us? Follow our LinkedIn channels & newsletters for expert insights, industry updates, upcoming events, and practical tips from our experts.

👉 Explore our LinkedIn channels & newsletters: https://eu1.hubs.ly/H0zbqx60

Trials

15/10/2026

How confident are you that your medical device software processes could withstand a regulatory review?

IEC 62304 provides the framework for developing and maintaining medical device software, but successful implementation requires more than documentation. It requires a risk-based approach, clear traceability, and processes designed to support both quality and compliance.

Whether you're developing embedded software, Software as a Medical Device (SaMD), or AI-enabled healthcare solutions, understanding IEC 62304 is essential.

Our latest article highlights the key principles of medical device software process design, including lifecycle management, risk-based development, quality assurance, and the challenges posed by modern technologies such as AI and cloud services.

Read the full article and subscribe to our newsletter: https://eu1.hubs.ly/H0z5TV70

Software is no longer just a component of many medical devices. In some cases, it is the medical device itself.

14/10/2026

Preparing a clinical study application?
Regulatory requirements are becoming increasingly complex, and managing submissions, amendments, and authority interactions can be both time consuming and resource intensive for sponsors.

Aurevia supports pharma, biotech and medtech companies, as well as academia, throughout the entire clinical study lifecycle, helping ensure applications are submitted efficiently and in compliance with applicable regulations.

Whether your study falls under the EU Clinical Trials Regulation (CTR), MDR, or IVDR, we can support you with:
• Regulatory strategy and planning
• Submission preparation and coordination
• Management of substantial and non-substantial modifications
• Responses to Regulatory Authorities and Ethics Committees
• Country-specific guidance across Europe
• Ongoing Clinical Trial Application (CTA) maintenance

Our goal is simple: to help you navigate the process with confidence while keeping your study timelines on track.

Let's discuss how we can support your next clinical study.

13/10/2026

Do you work with medical device software process design?
Together with Intertek Academy, we offer a 2-day course covering medical device software process design based on IEC 62304. This course is designed for professionals developing or managing medical devices containing software or software as a medical device (SaMD).

🔍 What you’ll learn:
• Current software practices
• Designing high-quality software in a regulated environment
• Standards for regulatory compliance
• Implementation examples for achieving compliance
• Practical applications of the requirements of the 62304 standard

🎯 Who should attend?
Professionals involved in software development, risk assessment, QA, process improvements, or procurement of software components/subcontractors.

📍 Location: Stockholm, Sweden (held in English)
🕘 Date: 25-26 November 2026
💰 Price: 15 200 SEK/1405 Euros (excl. VAT)
🎓 Led by Maria Rickardsson, Senior Quality & Regulatory Affairs Consultant at Aurevia
📩 Learn more: https://eu1.hubs.ly/H0z1BJw0

08/10/2026

CCLs bridge science, clinical practice, and stakeholder engagement
At Aurevia, we have experienced Clinical Country Liaisons (CCLs), a role that shares many characteristics with Medical Science Liaisons (MSLs), including a strong scientific foundation and stakeholder engagement focus. However, CCLs also play a broader role in supporting clinical development, from study feasibility and site engagement to collaboration with investigators throughout the clinical trial process.

Our consultants bring deep therapeutic expertise and hands-on experience working with investigators, healthcare professionals, and cross-functional teams to support successful study ex*****on and informed decision-making.

💬"My role is not only about sharing scientific knowledge. It's about building trusted relationships, understanding the realities of clinical practice, and bringing valuable insights back to the team to support better decisions and ultimately better outcomes for patients."
– Åsa Fransson, Clinical Country Liaison (CCL) at Aurevia

Whether supporting clinical studies, engaging with key opinion leaders, or providing scientific expertise in complex therapeutic areas, our CCLs help clients navigate challenges with confidence.

Our consultants combine deep scientific expertise with access to a broader network of clinical, regulatory, and medical affairs professionals. Contact us to discuss how the right expertise can strengthen your clinical development strategy, stakeholder engagement strategy, and study success.

07/10/2026

Need support with EUDAMED registration?
EUDAMED registration is now an important part of regulatory compliance for medical device and IVD companies operating on the EU market.

As of 28 May 2026, mandatory use of key EUDAMED modules has started, including Actor Registration and UDI/Device Registration.

Aurevia can support your organization throughout the EUDAMED registration process, including:
• Actor registration and SRN support
• UDI and device registration
• Basic UDI-DI and UDI-DI registration support
• EMDN code identification
• Review and preparation of required registration information
• Support for legacy device registration
• Guidance on MDR and IVDR registration requirements
• Practical support throughout the EUDAMED registration process

Whether you are registering for the first time, preparing device data or need support reviewing existing registrations, our QA/RA consultants can help you navigate the requirements and ensure that the required information is complete and consistent.

Contact us to discuss how we can support your registration activities: https://eu1.hubs.ly/H0yVH6F0

06/10/2026

📢CTIS update for sponsors and clinical trial teams
The email notification functionality has now been launched in the Clinical Trials Information System (CTIS). Users can choose to receive email alerts when new notifications or warnings are issued, providing an additional way to stay informed and keep regulatory activities on track.

A simple update that can help sponsors and study teams stay informed and respond more efficiently to important CTIS activities.

Learn more about this and other recent CTIS updates: https://eu1.hubs.ly/H0yT4830

05/10/2026

🚀 We've launched Medtech Compliance Insights, our new LinkedIn Newsletter!
Want the latest insights on regulatory affairs, quality, clinical research and medtech industry trends delivered directly through LinkedIn?

Subscribe to receive:
• Expert insights and perspectives
• Regulatory, quality and clinical research updates
• Industry news and trends

📩 Click Subscribe and join our growing community of medtech professionals.
https://eu1.hubs.ly/H0yQKhp0

Expert insights on MDR, IVDR, QMS, risk management, PMS, clinical evidence, regulatory compliance, and more.

01/10/2026

🔍 Do you work with medical devices and want to strengthen your knowledge on the requirements for clinical data and clinical evaluation under the MDR?

Join our upcoming course, developed in collaboration with Swedish Medtech, and gain knowledge on the clinical evidence requirements for getting a medical device CE marked.

📘 Course Highlights
• Clinical evaluation – an overview
• Regulatory context
• Clinical data
• Device-specific adaptation
• Equivalence
• Post-market clinical follow-up (PMCF)
• Step-by-step guidance on performing a clinical evaluation

🎯 Who should attend?
Quality and regulatory professionals in the medical device industry, and other medical device professionals interested in this topic.

🎓 What you’ll learn:
You’ll walk away with an understanding of the clinical evaluation process, its connection to risk management and post-market surveillance, and knowledge on the requirements for clinical evidence.

🗓️ Next session: Online, 9 October, 09:00–14:00 CET
💰 4300 SEK for Swedish Medtech members, 6100 SEK for non-members (excl. tax)
👩‍🏫 Course leader: Cecilia Emanuelsson, Senior Principal Consultant
🗣️ Course in Swedish | Materials in English
Learn more and register: https://eu1.hubs.ly/H0yKTV20