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    CRO clinical operations

    Clinical operations

     From standalone CRO services to full clinical study management, our team has the expertise to drive the success of your clinical research.

     

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    CRO clinical operations

    Clinical operation services for your clinical study

     Our experienced teams can help you plan, design and conduct your clinical study from start to finish. Whether you need support with standalone services such as feasibility studies, regulatory submissions, site management and monitoring, or an all-inclusive approach, we have the expertise to set you up for success by getting it right from the start. From clinical trials to clinical investigations and clinical performance studies, our international team has experience with a wide range of different indications and types of studies.

    Our clinical operation services cover: 

    • Clinical study start-up, including site and vendor setup, and site contract negotiation
    • Feasibility assessments and site evaluation
    • Regulatory submissions, including preparing documentation and submitting applications to competent authorities/CTIS and ethics committees
    • EU authorized representation for non-EU sponsors
    • Reporting in EudraCT
    • Site management, including regular contact with sites between visits
    • Monitoring, including SDV, query resolution, drug/device accountability and site training
    • Clinical project management
    • Medical writing
    • Data management and biostatistics
    • Pharmacovigilance and vigilance
    • Outsourcing services for when you need extra resources/interim solutions such as CPMs or CRAs.

     

    Get it right from the start

    Clinical study start-up

    Clinical study start-up is a complex and highly regulated part of a clinical study involving several stakeholders (sponsor, site, regulatory authorities, etc.). Study start-up includes many milestones starting with feasibility and ending with the enrollment of the first subject, with several activities in-between such as site selection, pre-study visit, regulatory submissions, site contract and budget negotiation, vendor set-up, and site activation.

    A successful clinical study start-up is a crucial first step and an important factor for the overall success of the trial. For this reason, we have experienced study start-up teams, offering customized services depending on your needs, whether full-service or single activities.

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    Feasibility assessments and site evaluation

    Feasibility assessment is one of the first steps in any clinical study and is critical to its success. These assessments are conducted to evaluate whether a study can be carried out in a particular country, at specific sites, or with selected investigators. The process helps identify the most appropriate sites and partners, enabling successful collaboration throughout the clinical study.

    Are you looking to identify suitable site(s) for your clinical study? We understand the importance of selecting study sites with the right experience and expertise—sites that can deliver high-quality data in accordance with the clinical study protocol, GCP, budget, and timelines. Suitable sites must also have access to an adequate patient population and possess the necessary time and resources to dedicate to the study. We work closely with specialized study centers, hospitals, and medical offices to select sites with the optimal patient population and recruitment potential for your study. Our experts conduct site qualification visits to confirm site suitability, and we also prepare budgets and negotiate contracts with the healthcare institutions.

    Regulatory submissions

     Regulatory submissions are critical milestones during study start-up and the outcome has a substantial impact on the timelines and conduct of the entire clinical study. Submission requirements vary between countries and the quality of submission packages can influence approval timelines. Changes are inevitable in clinical studies and these changes may require additional submissions (i.e., amendments) before implementation can take place. Our knowledge of local requirements for regulatory submissions and our focus on proactive planning and efficient communication are key to speeding up the submissions process and reducing timelines. Let us support you with your regulatory submissions during the entire clinical study period, from start-up to close-out.

    EU authorized representation for non-EU sponsors

    Under the terms of the 536/2014 Regulation in order to conduct clinical trials in the European Union, non-EU-based sponsors must have a European company as their authorized representative. We offer a contract with non-EU sponsors to provide authorized representation, including the responsibilities of the sponsor with regards to GCP and regulatory compliance.

    Site management and clinical monitoring

    Proper site management is an essential factor in executing a clinical study successfully. Site management is much more than simply monitoring a study site, it’s about developing a solid working relationship with the site through regular and consistent communication. We understand the central role that sites play in the outcome of a clinical study. We establish a trust-based relationship with each site, maintaining an appropriate level of oversight and supporting the study personnel throughout all phases of the clinical study.

    Adequate clinical monitoring of trials is imperative and guarantees the subjects’ rights and welfare, data quality, and regulatory compliance. We have experience in a wide range of therapeutic areas and can offer fit-for-purpose monitoring services for all types of clinical studies. Routine monitoring is performed according to ICH-GCP standards, applicable guidelines, and local regulatory requirements.

    Monitoring activities include:

    • Training site staff on the study protocol, your product, and ICH-GCP requirements
    • Reviewing regulatory and protocol compliance
    • Conducting remote monitoring for Electronic Data Capture (EDC) studies
    • Reviewing Case Report Forms (CRFs)
    • Maintaining and updating study documentation
    • Maintaining regular communication with sites between on-site visits
    • Managing drug/device inventory and accountability
    • Performing safety reviews
    • Conducting Source Data Verification (SDV)

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    Our customer-centric approach means that our client’s needs guide our focus to create impactful results.  

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