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We provide specialized and efficient clinical trial management services, designed to precisely meet your development goals. From strategic regulatory planning to effective study execution, we ensure operational agility, scientific rigor, and compliance with the highest quality standards.

Project Management

Project Management

Comprehensive oversight and coordination, ensuring timely delivery and high-quality outcomes.

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Regulatory Affairs

Regulatory Affairs

Expert guidance through Swiss regulatory processes, ensuring efficient submissions, approvals, and compliant study execution.

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Legal Representation

Legal Representation

Swiss legal representation and regulatory support, facilitating compliant interactions with Swissmedic and Ethics Committees.

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Study Design and Protocol Writing

Study Design and Protocol Writing

Expert scientific input and clear, compliant protocol development tailored to your clinical objectives and therapeutic area.

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Start-Up Activities

Start-Up Activities

Efficient set-up of clinical studies including feasibility assessments, site selection and essential documents preparation.

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Site Management

Site Management

Proactive site engagement and operational support, building strong investigator relationships and ensuring compliance and performance across study sites.

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Data Management

Data Management

Reliable collection, management, and analysis of clinical data, ensuring accuracy, integrity and regulatory compliance.

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Statistics

Statistics

Biostatistical support from design to submission, ensuring data integrity, compliance, and informed decision-making.

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Risk-based Monitoring

Risk-based Monitoring

Proactive and precise clinical monitoring activities to guarantee data integrity and compliance with the study protocol and regulations.

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Study Close-Out

Study Close-Out

Structured trial closure, including database lock, final data validation, budget reconciliation, essential document archiving, and preparation for regulatory submission.

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Inspection and Audit Support

Inspection and Audit Support

Thorough preparation and assistance during audits and inspections, ensuring readiness and compliance.

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Others Activities

Others Activities

Strategic support beyond trials: from IMP logistics and vendor oversight to feasibility, registration, insurance, audits, and publications.

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See also our Marketing Authorization and Regulatory Services

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