Clinical Research Categories

At CORONIS Research, we bring science, precision, and commitment together to deliver exceptional clinical development solutions. From early human studies to post-marketing research, our full-service CRO supports your product’s lifecycle with efficiency, regulatory confidence, and uncompromising quality.

Launching a new clinical program is an ambitious milestone — and CORONIS Research is your trusted partner to make it a successful one.

As a full-service CRO in Europe, we provide end-to-end support — from clinical study design to final data delivery — ensuring your clinical trials are executed with precision, speed, and scientific excellence.

Early Development Clinical Trials

Our expertise spans the full spectrum of early-phase research, enabling rapid, high-quality insights that drive smarter decisions.

We specialize in:

  • First-in-Human (FIH) Trials – Assessing safety and tolerability of investigational products in humans.
  • Single Ascending Dose (SAD) Studies – Determining maximum tolerated dose through sequential escalation.
  • Multiple Ascending Dose (MAD) Studies – Evaluating safety, pharmacokinetics, and pharmacodynamics over time.
  • Food-Effect Studies – Measuring how diet influences absorption and bioavailability.
  • Bioequivalence Studies – Comparing pharmacokinetic profiles of formulations to demonstrate equivalence.
  • Pharmacokinetic (PK) Trials – Understanding drug absorption, distribution, metabolism, and excretion.
  • Pharmacodynamic (PD) Trials – Analyzing biological effects and mechanism of action.
  • Proof-of-Concept (PoC) Investigations – Early efficacy validation in target populations.
  • Phase I – Safety & Dose-Finding Studies – Comprehensive safety profiling and dose optimization in healthy volunteers or patients.

With a state-of-the-art Clinical Unit specifically designed to conduct complex and intensive studies involving both healthy volunteers and patient populations, we can assure:

  • Dedicated wards with 24/7 monitoring
  • Access to advanced diagnostic and accredited laboratory infrastructure
  • On-site intensive care unit (ICU) available around the clock
  • Accelerated patient recruitment through a robust volunteer database

At CORONIS, we don’t just run studies — we align your clinical and commercial strategies from day one, helping transform innovation into measurable success.

Phase II–IV Clinical Development

Successful late-phase clinical development requires more than experience — it demands foresight, precision, and operational excellence.

At CORONIS Research, we combine scientific expertise with hands-on management to guide your Phase II–IV clinical trials from design to submission-ready data, efficiently and with full regulatory compliance.

Every project we manage follows a structured, results-oriented approach designed to ensure the success of your study and the integrity of your data.

Clinical Feasibility Assessment

A strong study begins with informed planning.
Our team conducts a detailed clinical feasibility assessment to understand your protocol requirements, regulatory pathway, and site capabilities. We then design a targeted operational strategy — optimizing timelines, reducing cost, and mitigating risk before your trial begins.

Recruitment Planning & Enrollment Success

Enrollment is often the biggest challenge in clinical research. At CORONIS, we use data-driven recruitment planning supported by in depth analysis of site capabilities and deep local insight. This allows us to identify potential barriers early, engage motivated sites, and reach enrollment targets faster without compromising data quality.

Rapid & Compliant Trial Execution

Once your trial is initiated, our focus is flawless delivery.
We ensure fast site activation, milestone adherence, and continuous quality oversight. Our integrated quality management framework enables early identification of potential issues and ensures swift resolution, maintaining strict regulatory compliance and the highest standards of clinical excellence. The result: consistent compliance, reliable outcomes, and submission-ready data.

Partner with CORONIS Research to experience a clinical development process that’s efficient, compliant, and strategically aligned with your goals.

Real-world insights are transforming the way healthcare decisions are made.

At CORONIS Research, we design and conduct Real World Evidence (RWE) studies that bridge the gap between clinical research and everyday clinical practice.

Our mission is to generate high-quality, regulatory-compliant data that demonstrates real-world effectiveness, supports market access, and enhances patient outcomes.

Registries & Observational Studies

Understanding how diseases evolve and treatments perform in real-life settings is fundamental to better healthcare.

Our team develops and manages patient registries and observational studies that capture longitudinal, real-world data to inform clinical, regulatory, and commercial strategies.

Through carefully designed protocols and validated methodologies, CORONIS helps you:

  • Assess disease prevalence and incidence
  • Understand treatment patterns and patient adherence
  • Measure long-term safety and effectiveness
  • Identify unmet medical needs and improve care pathways

With deep expertise in chronic and rare diseases, we ensure that every study produces meaningful evidence to guide better treatment decisions.

Post Authorisation Safety Studies (PASS)

Ongoing safety evaluation is essential to maintaining confidence in medicinal products.

CORONIS conducts Post Authorisation Safety Studies (PASS) to identify, characterize, and quantify potential safety risks  ensuring compliance with Good Pharmacovigilance Practice (GVP) guidelines and all regulatory requirements.

Our services include:

  • PASS protocol development and regulatory submission
  • Study conduct and data management
  • Risk evaluation and mitigation planning
  • Preparation and submission of final safety reports

Whether your PASS is mandated by authorities or initiated voluntarily, CORONIS ensures scientific integrity, robust methodology, and timely delivery of results that strengthen product safety profiles.

Post Authorisation Efficacy Studies (PAES)

As understanding of diseases and treatments evolves, additional efficacy data is often required post-approval.

We design and implement Post Authorisation Efficacy Studies (PAES) to complement pre-marketing evidence and confirm therapeutic benefit under real-world conditions.

Our medical and regulatory teams manage the entire process — from protocol development to report submission — and assist in interpreting findings for product labeling updates, risk-benefit evaluations, and regulatory interactions.

The result: actionable evidence that reinforces the clinical and commercial value of your medicinal product.

Patient Reported Outcomes

Patient insights are reshaping modern clinical research.

At CORONIS, we integrate Patient Reported Outcomes (PROs) into studies to capture the real impact of treatment on quality of life, symptom burden, and satisfaction.

Our expertise includes the design and deployment of electronic PRO (ePRO) systems to ensure high-quality, real-time patient input while reducing data entry errors and improving compliance.

These outcomes provide powerful, patient-centered evidence that enhances both clinical understanding and market access strategies.

Pharmacoeconomic Studies

In today’s competitive healthcare environment, demonstrating value is as important as demonstrating efficacy.

CORONIS designs and conducts pharmacoeconomic studies that evaluate the cost-effectiveness, cost-utility, and overall economic impact of therapeutic interventions.

Our analyses help you:

  • Support reimbursement and health technology assessment (HTA) submissions
  • Optimize resource allocation and pricing strategies
  • Demonstrate value-based outcomes to payers and stakeholders

By integrating clinical outcomes with economic modeling, CORONIS delivers insights that drive informed, sustainable healthcare decisions.

Innovation in medical technology moves faster than regulation — and that’s where CORONIS makes the difference.

Running a medical device or diagnostics clinical trial isn’t about replicating pharmaceutical models; it’s about creating purpose-built strategies that fit the unique science, speed, and compliance landscape of medtech.

With over a decade of hands-on experience and 30+ successful device trials, CORONIS has developed a methodology that aligns clinical precision with commercial vision. We combine operational agility with deep regulatory insight, helping sponsors translate groundbreaking ideas into verified, market-ready solutions.

Our dedicated Medical Device team understands the fine balance between innovation and compliance. We focus on what truly defines success:

  • Tailored study design aligned with MDR/IVDR requirements
  • Strategic regulatory navigation to streamline submissions
  • Investigator and site training to ensure flawless protocol adherence
  • Data integrity and traceability to meet global audit standards

From first-in-human through post-market studies, CORONIS builds clinical pathways that don’t just meet endpoints — they build market confidence. Whether your goal is CE marking, regulatory approval, or evidence generation for reimbursement, we ensure your device reaches patients safely, swiftly, and successfully.