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  • Athinon 6, Sea View Point, Suite 201, 7573 Anafotida, Larnaca, Cyprus
CY +357 99 272782 | GR +30 697 728 9821

Study Start-Up

Comprehensive Support Across All Study Start-Up (SSU) Phases

Our Study Start-Up (SSU) services are designed to establish a strong foundation for efficient, compliant, and timely clinical trial initiation. With over 15 years of experience in clinical research, our team provides comprehensive support throughout all phases of study start-up, working closely with sponsors and partner CROs to streamline processes and facilitate site activation.

Our Study Start-Up services include

  • Feasibility Assessment

    Evaluating study feasibility and site capabilities to support trial execution.

  • Site Identification and Selection

    Identifying and selecting suitable clinical study sites based on study requirements.

  • Regulatory and Ethics Committee Submissions

    Preparing and coordinating initial and amendment submissions to Regulatory Authorities and Ethics Committees.

  • Contracts and Budgets

    Supporting the preparation, review, and finalization of site contracts and study budgets.

  • Essential Documents Management

    Collecting, reviewing, and managing essential study documentation to support regulatory compliance and site readiness.

  • Site Activation

    Coordinating the activities required to prepare sites for study initiation.
We help our clients navigate the complexities of study start-up, optimize timelines, and ensure readiness for clinical trial initiation. Our commitment to efficiency, regulatory compliance, and collaboration makes Abrazo Research a trusted partner in supporting clinical research from the earliest stages.

Regulatory Expertise in Greece and Cyprus

Our team is familiar with the European regulatory framework and national procedures governing clinical trials in Greece and Cyprus. We support sponsors and partner CROs in navigating regulatory and ethics committee requirements, coordinating submissions, and managing study start-up activities in accordance with applicable regulations and procedures.

Our regulatory and institutional experience includes

European Regulatory Framework

European Medicines Agency (EMA), Clinical Trials Information System (CTIS), and the EU Clinical Trials Regulation (Regulation (EU) No 536/2014).

Greece

National Organization for Medicines (EOF) and the relevant Greek ethics committees.

Cyprus

Cyprus National Bioethics Committee, Ministry of Health, and the relevant competent authorities.

Clinical Research Institutions

Experience coordinating with medical institutions and clinical study sites in Greece and Cyprus.