European Clinical Research Organization

Where experience meets execution

Novellas Healthcare supports pharmaceutical, biotech, and healthcare companies with agile, high-quality clinical research solutions designed to accelerate development while maintaining the highest standards of compliance and patient focus.

Why choose Novellas Healthcare?

Sharp

Precision in every detail

In clinical research, every decision matters. Our approach is sharp, focused, and highly responsive — ensuring studies move forward with clarity, accuracy, and efficiency.

  • We can focus quickly
  • We are pro-active and provide clear and transparent communication
  • We are volatile, we can adapt immediately to the needs of our clients
  • We want to think with our client
  • We integrate into the DNA of the client
  • We have streamlined operational processes that reduce delays and increase study performance
  • We pay meticulous attention to regulatory compliance and data quality

Leading Expertise

The right experts. Exactly when you need them.

Successful clinical research depends on having the right people in place at the right moment. Thanks to our strong foundation in pharmaceutical staffing and patient support programs, we offer something truly distinctive: direct access to an extensive network of highly specialised professionals across the life sciences industry.

Our unique combination of CRO services and staffing expertise enables us to rapidly identify, engage, and deploy the precise profiles required for every phase of a project — from clinical operations and medical affairs to patient engagement and regulatory support.
Whether a project requires strategic leadership, operational reinforcement, or highly specific therapeutic expertise, we ensure the right capabilities are available exactly when they are needed.

We don’t simply provide resources — we connect our clients with the expertise that drives clinical research forward. Our team is a flexible community of highly experienced experts, carefully tailored to each client’s specific needs. We only work with professionals who bring real-world insight—people who have done it before and understand the complexities firsthand. Rather than simply providing resources, we embed individuals with lived experience, ensuring practical knowledge, stronger execution, and immediate value from day one.

Driving smarter clinical solutions

The clinical research landscape is evolving rapidly, and innovation is no longer optional — it is essential.

We continuously develop forward-thinking solutions that improve efficiency, patient engagement, and study outcomes. By combining industry insight with modern operational strategies, we help sponsors navigate complex research environments with confidence.
Our innovative mindset includes:

  • Patient-centric approaches that improve recruitment and retention
  • Flexible resource models adapted to changing study demands
  • Creative, pragmatic problem-solving for operational and staffing challenges in your trial
  • A proactive approach to emerging trends in clinical development

We challenge conventional thinking to create smarter, faster, and more effective research support.

We don’t believe in unnecessary complexity. We believe in smart execution, fast adaptation and delivering results with precision. 
Partnership, not just a project.

Expertise across every phase of clinical development

Our extensive network of clinical research professionals enables us to support studies across the entire clinical development lifecycle — from early-stage planning and study start-up to trial execution, patient engagement, and post-study activities.
Thanks to our strong staffing capabilities and deep industry connections, we have access to highly specialised experts who bring both scientific knowledge and operational experience to every project.

We provide expertise across:

Feasibility and site selection

Selecting the right sites is critical to ensure study quality and recruitment efficiency.
Our teams conduct detailed feasibility assessments to identify  the right sites for  your study.

Regulatory submissions

Our regulatory specialists support the preparation, coordination, and submission of clinical trial applications through the Clinical Trials Information System (CTIS), in full compliance with the European Clinical Trials Regulation (CTR). We ensure efficient management of submission packages, ethics committee documentation, and regulatory communications to facilitate smooth study approvals across EU Member States.

Patient recruitment and support

With our strong background in patient support programs and healthcare services, we help sponsors improve patient recruitment, engagement, and retention throughout the clinical trial journey.

Our patient-centric approach supports efficient recruitment processes, strong participant communication, and tailored support strategies that enhance the patient experience and contribute to successful study outcomes.

Data management & statistics

We support clinical studies with reliable data management and statistical expertise to ensure high-quality, accurate, and compliant study data throughout the research process.

Through our network of experienced professionals and trusted specialist partners, we provide flexible support tailored to the specific needs and complexity of each project — from data handling and validation to statistical analysis and reporting.

Our collaborative approach ensures efficient, consistent, and high-quality delivery across all stages of data management and biometrics.

Project & site management

Our experienced project and site management professionals ensure smooth coordination and efficient execution throughout every stage of a clinical trial.

We support sponsors with proactive oversight, clear communication, and operational excellence, helping studies stay on track while maintaining high quality standards across sites and stakeholders.

Quality & compliance

Quality and compliance are embedded in every aspect of our clinical research services. We operate in accordance with ICH-GCP guidelines and work within a quality framework aligned with ISO 9001 standards, ensuring consistent, reliable, and compliant study support.

Our experienced quality professionals can support clients across a wide range of quality and compliance activities, helping to maintain high standards throughout the clinical trial lifecycle.

In addition, our expert pool covers a broad spectrum of therapeutic areas, allowing us to rapidly match the right expertise to the specific scientific and operational needs of each study.

Whether supporting small, complex, highly specialised studies or large-scale programs, we ensure our clients have access to the capabilities they need to move clinical research forward with confidence and efficiency.

We act as matchmakers in clinical research, connecting the right expertise, technology, and partners to accelerate better outcomes—while bringing a sense of fun and joy into everything we do.

We provide functional, embedded, as well as full-service solutions for your clinical research activities.

Functional sourcing

Access highly skilled, professionally trained experts who can be flexibly deployed to support specific functions or project, exactly when your organisation requires additional capacity.

Our functional sourcing model combines the flexibility of freelance support with the reliability and quality standards of an established clinical research organisation.

Embedded/consultancy

Our embedded solutions & consultancy model places experts directly within your teams, enabling close collaboration across clinical, operational, and technical functions. This embedded model reduces complexity, increases agility, and strengthens collaboration across clinical and technical teams.

Fulll-services sourcing

We provide full-service solutions that support the complete lifecycle of your clinical development – from study start to final delivery. With integrated teams, therapeutic expertise and flexible delivery models we help sponsor accelerate timelines while ensuring quality and operational excellence.

flexible clinical support solutions mapping

Close collaboration between sponsors, investigators and clinical teams is key to successful studies.

Our Clinical Services

Phase I Clinical Studies

Early development programs require precision, regulatory alignment and carefully selected clinical sites.

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Phase II Clinical Studies

Proof-of-concept trials require strong operational execution and optimized patient recruitment strategies.

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Phase III Clinical Studies

Large multicenter trials require efficient coordination and transparent study management.

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Phase IV & RWE

Generate meaningful insights from post-marketing studies and real-world data.

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Your ideal CRO partner

We are a small, agile partner with the speed and focus to move fast—and the capability to deliver outsized impact where it matters most for our clients. We combine a lean administrative structure with deep domain expertise, delivering high-quality services in a cost-efficient way.

Do you have a project or innovative idea?
If you believe we can support your ambitions, we would be delighted to explore new collaborations and healthcare initiatives together.

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