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Aurevia CRO and QARA Services

Name: Aurevia CRO and QARA Services
Address: Skolgatan 8, Uppsala, 75311, SE
Telephone: +4618100550

Hem
Sverige
Uppsala
Aurevia CRO and QARA Services

Aurevia was formed in 2025 when Scandinavian CRO, QAdvis, Artimed, Clinical Consulting, Kasve, and P.R.I.S.M.A. CRO merged.

QAdvis and Scandinavian CRO (SCRO) are now Aurevia, offering consulting services within medtech regulatory compliance, as well as clinical research CRO services supporting pharmaceuticals, ATMPs, biologics, medical devices, and IVD devices. Aurevia offers consulting services within medtech regulatory compliance, as well as clinical research CRO services supporting pharmaceuticals, ATMPs, biologics

, medical devices, and in vitro diagnostic devices. Our services for the healthcare, pharmaceutical, and medical technology sectors cover quality assurance, regulatory affairs, clinical studies, training, and more. With teams in the Nordics, Germany and Poland, we are highly skilled experts that support medical device and in vitro diagnostic (IVD) manufacturers, pharmaceutical companies, and academia throughout their product development. Together, we pave the way for safer, more effective patient care worldwide. Feel free to contact us at +46 (0)8 10 05 50 or [email protected]

17/06/2026

As we head into the summer season, we’d like to take a moment to say thank you.

To our customers and partners — we truly value working with you and the trust you place in us.

We wish you a wonderful summer, with time to recharge and space to enjoy the moments in between. 🌻🌱🌞

15/06/2026

Struggling to manage quality processes efficiently as your organization grows?
At Aurevia, we deliver reliable and scalable electronic Quality Management System (eQMS) solutions—built on Atlassian Jira and Confluence—to support your entire quality lifecycle.

✅ Streamlined document control with approval workflows and versioning
✅ Clear roles, training records, and full traceability
✅ Tailored processes for CAPA, feedback handling, and more
✅ A versatile and compliant eQMS documentation environment

Our solutions are designed to be cost-effective and tailored to your needs, helping you build a robust foundation for your quality management process that can be scaled with confidence.

👉 Curious to see how it works? Book a free demo and explore how an eQMS can support your quality management processes: https://eu1.hubs.ly/H0w83040

11/06/2026

✨ Excited to be recognized as one of five European Digital Innovation Hub (EDIH) Community Award finalists at the EDIH Summit 2026! ✨

This recognition belongs to HealthHub Finland EDIH (HHFIN) and the joint work behind the initiative “Towards Simplified Regulatory Compliance: A Comprehensive Digital Tool for Innovators”—where we’ve contributed to expanding the Entries e-tool across frameworks such as the AI Act, Data Act, EHDS Regulation, MDR and IVDR. This collaborative effort has been supported along the way by various public organizations including the Finnish AI Region (FAIR EDIH).

What stands out is the broader momentum across Europe where EDIHs and AI initiatives are coming together to help innovators and SMEs navigate regulatory complexity and succeed in the market.

One of the key challenges that remains is ‘regulatory clarity’—not the regulations themselves, but the ability to understand and act on them early. It’s encouraging to see that this challenge is being recognized and that practical solutions are moving forward.

Thank you to every partner who has been part of this journey, and congratulations to the other finalists for the important work they’re doing in shaping Europe’s digital future.

👉 Last but not least, a big thank you to the organizers of the EDIH Summit for bringing this amazing community together.

10/06/2026

Scandinavian CRO is now Aurevia
Two years ago, we became part of something bigger. At first, the change was mostly visible on paper — a new owner and later a new name: Aurevia. But this was never just about ownership or branding. It was about strengthening what we already do well — and unlocking new possibilities for the future.

Built on a strong foundation
Our reputation has always been built on close relationships, deep expertise, and a clear focus on delivering value to our customers. That foundation hasn’t changed. If anything, it has become even more important.

Stronger together
Becoming Aurevia has given us access to broader knowledge, expanded resources, and new perspectives. This allows us to support our customers with deeper expertise, greater capacity, and more opportunities to grow together.

Looking ahead
Our name has changed, but our commitment hasn’t. You’ll still meet the same people with the same dedication. And now, you’ll gain more insight, innovation, and new ways forward.

With a stronger offering of quality, regulatory, and clinical research services, we move forward with renewed focus on what matters most — creating value for our customers, every single day.

Because this was never just a name change.
It’s a step towards something better.

09/06/2026

AI and automation towards better quality of care
Forsante Oy’s MDR-certified IRMA decision engine helps automate clinical processes, reduce manual work, and supports more consistent treatment pathways.

We’re proud to have supported Forsante in building its ISO 13485 quality management system and technical documentation aligned with MDR requirements. This is a great example that highlights the value of combining innovation with the right regulatory expertise.
As Antti Särelä, CEO of Forsante puts it, "Aurevia's experts understood the needs of a small company well and were able to tailor solutions that suit us without extra burden. Our collaboration with Aurevia covered everything from building a quality system to compiling a technical file. Our goal was to get an optimally built system that is not too heavy but meets all the requirements."

Read more: https://eu1.hubs.ly/H0v_XGy0

08/06/2026

ASCO 2026 may be over, but we’re still feeling inspired! ✨💡
Thank you to everyone who connected with us during an inspiring week filled with groundbreaking science, thoughtful discussions, and a shared commitment to improving patient outcomes.

ASCO once again demonstrated how collaboration across the oncology community drives real progress—from early research to clinical practice. We’re bringing valuable insights home and look forward to continuing the conversations beyond the meeting.

04/06/2026

🌞 Great discussions this morning at the Breakfast meeting & SweTrial kick-off hosted by STUNS in Uppsala.

The session brought together representatives from academia, healthcare, industry, and authorities to explore how we can strengthen Sweden’s position in clinical trials—through collaboration, improved processes, and smarter patient recruitment.

Thank you to Charlotta Elfström, Clinical Operations Director at Aurevia, who contributed to the panel discussion along with other key stakeholders from across the ecosystem.

One key takeaway is that unlocking the full potential of clinical trials in Sweden will require closer collaboration across the entire ecosystem—and a shared focus on quality, efficiency, and innovation.

Thank you to STUNS and all participants for an engaging and forward-looking discussion.

03/06/2026

Most people underestimate what data management really means in medtech & IVD

In pharma, data management is typically focused on getting clean, consistent, and traceable clinical data—which means that data anomalies are usually handled during data cleaning. But in medtech and IVD, anomalies can signal something else entirely.

📊 Example: a scanned patient ID gets misinterpreted → the wrong patient is linked downstream.
Looks like a data error, but it could be a device or system issue.

That changes the role of data management:
• Don’t just clean data—understand it
• Don’t just fix errors—trace their origin
• Don’t disregard anomalies—learn from them

From a data management perspective, the goal isn’t perfect data, but to understand real device performance—including its limitations.
-Sebastian Carlsson, Data Manager at Aurevia.

At Aurevia, we combine our data management knowledge with our deep expertise of devices, complex data flows, and regulatory expectations for medtech and IVD.

The result? Data you can trust—and evidence that stands up to scrutiny.

01/06/2026

🎯 We’re live at ASCO 2026 in Chicago – meet us at booth #37120 ✨

The energy, the science, and the conversations here truly highlight why ASCO is the place where oncology progress takes shape—bringing together clinicians, researchers, industry, and innovators from across the globe.

For Aurevia, it is a valuable opportunity to meet sponsors, pharma, biotech and medtech companies, and research partners working on the next generation of oncology therapies and diagnostics.

As a European CRO and regulatory partner, we support clinical research projects across Europe, combining regulatory strategy, quality assurance, patient safety and clinical operations expertise.

📍 If you are attending ASCO and would like to discuss clinical trial support in Europe, regulatory strategy or potential collaboration, feel free to connect or visit the Aurevia team at booth #37120.

29/05/2026

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/H0vKc7x0

Adress

Skolgatan 8
Uppsala
75311

Öppettider

Måndag	09:00 - 17:00
Tisdag	09:00 - 17:00
Onsdag	09:00 - 17:00
Torsdag	09:00 - 17:00
Fredag	09:00 - 17:00

Telefon

+4618100550

Webbplats

https://www.aurevia.com/

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