Every successful clinical trial starts with the right sites.

At CORONIS Research, we know that feasibility, site selection, and activation are the most decisive factors in determining study timelines. Our extensive investigator network and local market insight allow us to identify the optimal sites for each protocol — those capable of meeting recruitment goals and generating high-quality data.

Through targeted feasibility assessments and data-driven evaluations, we ensure that every site we select aligns with your study’s operational and therapeutic needs.

Our start-up specialists work closely with investigators to streamline initiation activities, minimize administrative delays, and guarantee on-time site activation — keeping your study moving from planning to first patient in, faster.

From submission to activation — seamless start-up management with regulatory precision.

At CORONIS Research, we turn complex study initiation into a streamlined, predictable process.

Our Study Start-Up Management service integrates all critical early-stage activities — regulatory submissions, contract negotiation, and site activation — under one coordinated framework designed to accelerate your clinical trial’s launch.

From the preparation of regulatory and ethics submissions to contract finalization and essential document collection, our experts ensure that every element aligns with study timelines and compliance requirements. We combine deep knowledge of local and international regulations with operational agility, ensuring that approvals, agreements, and site readiness advance in parallel — not sequentially.

Through proactive collaboration with sponsors, investigators, and authorities, we minimize administrative delays, anticipate challenges, and keep projects moving efficiently toward first-patient-in.

The result: faster start-up, transparent communication, and complete regulatory confidence — so your study begins strong and stays on track.

A well-prepared team is the key to a successful trial.

CORONIS designs and delivers Investigator Meetings that go beyond information sharing — they inspire collaboration, clarify expectations, and strengthen engagement among investigators and site staff.

Whether hosted virtually or in person, our meetings are structured to align all stakeholders on study objectives, regulatory requirements, and protocol details.

Each session is designed to build confidence, ensure consistency, and create a shared commitment to study excellence.

At CORONIS Research, project management is not just coordination — it’s orchestration.

Each study is entrusted to a dedicated, highly experienced Clinical Project Manager (CPM) who serves as your single point of contact and the driving force behind study execution.

Our project managers combine therapeutic insight with operational discipline to ensure every milestone is met — on time, on budget, and in compliance. They lead cross-functional teams, anticipate challenges, and apply proactive problem-solving to keep projects moving seamlessly from start-up to close-out.

Whether managing early-phase, late-phase, or post-marketing programs, our team’s commitment remains the same: precision, transparency, and delivery you can rely on.

With CORONIS, you gain a partner who manages not just tasks, but outcomes.

The success of a clinical trial depends on the people behind it — and our Clinical Research Associates (CRAs) embody the highest standards of professionalism, ethics, and expertise.

At CORONIS, we ensure that every CRA is rigorously trained in ICH-GCP, regulatory compliance, and best practices in site oversight.

Their role extends beyond source verification — they act as quality ambassadors, safeguarding data integrity, patient safety, and protocol adherence at every visit.

Our monitoring approach is designed to ensure that your trial not only meets regulatory expectations but also achieves operational excellence across all sites.

Efficiency and quality are not opposing goals — they are complementary when managed intelligently.

Our Risk-Based Monitoring model applies a focused, data-informed approach to site oversight, targeting resources where they matter most.

By mapping study-specific risks and integrating advanced data review tools, we tailor each monitoring plan to the protocol’s complexity and patient population.

The outcome: optimized monitoring efforts, reduced costs, and consistently high-quality data — delivered through the combined expertise of our project managers, CRAs, and scientific advisors.

A successful study is built on engaged and well-supported investigator sites.

Our Site Management team provides continuous operational and logistical support throughout the entire study lifecycle. From initiation and enrollment to data review and close-out, CORONIS ensures that every site remains motivated, compliant, and aligned with study timelines.

Through close collaboration, consistent communication, and performance tracking, we strengthen site relationships and maintain momentum — ensuring your study delivers high-quality data efficiently.

Accurate documentation is the backbone of regulatory compliance and scientific credibility.

CORONIS offers secure, organized, and fully compliant Records Management services that meet both ICH-GCP and GDPR standards.

Our controlled systems ensure traceability, accessibility, and confidentiality across all study materials — from essential documents to electronic archives.

Whether for audits, inspections, or long-term retention, your data remains complete, protected, and inspection-ready at every stage.

Every successful site deserves reliable support.

Our Site Support Services provide investigators with the operational assistance they need to focus on patient care and protocol delivery.

From study logistics and documentation handling to subject scheduling and coordination, CORONIS acts as an extension of your team — simplifying processes, reducing administrative load, and ensuring consistent site performance.

Precision, compliance, and care — at every step of the supply chain.

At CORONIS Research, we recognize that effective IMP management is fundamental to the integrity and success of every clinical trial.

Our dedicated operations team ensures full compliance with GMP, GDP, and ICH-GCP standards, as well as national and international regulatory requirements, throughout the entire product lifecycle — from receipt to final disposition.

We provide end-to-end IMP logistics and accountability management, ensuring investigational products are handled securely, stored under validated conditions, and delivered accurately and on time to investigational sites.

Our IMP Management Services include:

• Receipt and secure storage in temperature- and environment-controlled facilities
• Labeling and packaging according to protocol and regulatory requirements
• Distribution coordination to investigational sites across multiple regions
• Inter-site transfer management, ensuring continuity and compliance
• Recall, return, and destruction procedures performed in line with sponsor SOPs and national legislation

Through careful planning, documentation, and oversight, we maintain full traceability and regulatory compliance at every stage of IMP handling — safeguarding both product integrity and patient safety.