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Superior processes from start to finish

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CLINICAL OPERATIONS

[/fusion_text][fusion_separator style_type=”default” border_size=”2″ alignment=”center” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” bottom_margin=”30px” width=”280px” /][fusion_text rule_style=”default” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility”]

Effective management of clinical operations requires continuity, stability and constant exchange of information. In order to deliver the highest quality support, we allocate an experienced team to accompany your project team from start to finish, with the resources and flexibility to cover every aspect of clinical trial management. To ensure that your trial runs as efficiently as possible before it even begins, we carry out a comprehensive feasibility study to identify and mitigate risks (medical, regulatory, operational, etc.) and to accurately estimate time and costs.

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“The basis of our operations is a reliable, personal and long-term co-operation with our customers. You have our undivided attention.”

Dr. Michael Binder, Director Operations

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We rely on the individual competence and responsibility of our team members. In this way, we offer our clients flexibility combined with personal commitment and team-oriented cooperation. Project managers provide study leadership while execution is backed by the entire team’s joint experience and resources. The oversight and management of your study is coordinated through our in-house CTMS, InSIGHT, a platform designed to optimize all workflows and processes, reducing time and costs while increasing quality.

Contact us to discover how we can support your clinical operations:

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Study road mapping

At SCOPE, we know that comprehensive and accurate initial project evaluation is the key to success. Our internationally experienced operational professionals ensure that all potential risks are fully assessed – operational, budgetary, medical, statistical, ethical and regulatory – and that strategies are developed to mitigate them. We consider this a crucial assessment for country and site selection when estimating time as well as costs in addition to overall project planning.

  • Comprehensive feasibility research
  • Close cooperation with our international network of reliable investigators
  • Country and site selection
  • Full risk assessment and quality planning
  • Realistic time and cost planning

[/fusion_toggle][fusion_toggle title=”Project Management” open=”no”]

Proactive study management – we are with you all the way

Your business is our business. We take a ‘hands-on’ approach, reacting quickly and managing proactively. We coordinate with all involved parties –the operational teams, third-party vendors and study sites and in turn provide you with a single point of contact, allowing for fast, reliable and flexible decision-making. Our team-oriented lean approach ensures that you get just as much project management as you need.

Why not get in touch to discover how we can support you?

  • Centralized project management for optimal communication
  • Dedicated project management team from start to finish
  • Comprehensive-time and budget management
  • InSIGHT CTMS for continuous process optimization and transparency, with continuous 360° project overview
  • Flexible capacity to fit your needs

[/fusion_toggle][fusion_toggle title=”Clinical Monitoring & Site Management ” open=”no”]

Expert eyes on your data

Site training, motivation, and meticulous clinical monitoring in accordance with ICH-GCP standards are crucial to obtaining evaluable study data. SCOPE builds local monitoring teams with experienced clinical research associates (CRAs), who closely manage site performance to avoid protocol violations, maintain low query rates, and ensure study enrollment as well as on-site logistics.

SCOPE deploys teams of local office-based, permanent CRAs from national offices to provide a cost-effective solution. Consistent high-quality clinical monitoring is ensured through periodic co-monitoring of all trials, coupled with project-specific monitoring plans and periodic CRA training and mentorship delivered by CRA managers.

Our CRAs have considerable clinical research expertise, broad therapeutic experience, and strong communication and interpersonal skills that are vital for good site-sponsor relationships. At SCOPE, we believe that clinical operations are not only about making sure that the project runs smoothly through high-quality monitoring and management, but also about delivering personalized services.

Our site management process ensures fast, proactive support that you and the sites can rely on. Our CRAs provide general and study-specific site training (e.g. ICH-GCP, protocol, EDC systems), have continuous site overview, perform remote monitoring, and support the sites to optimize their recruitment strategy. They maintain close personal contact to identify and solve any potential problems as well as maintain site motivation.

  • Expert, experienced CRAs (permanent, local and office-based)
  • All monitoring activities in accordance with ICH-GCP standards
  • Co-monitoring and training programs to ensure quality across all sites and countries
  • Risk-based monitoring
  • Remote monitoring
  • Site overview and proactive site management
  • Site training and support with the study documentation
  • Patient recruitment strategies

[/fusion_toggle][fusion_toggle title=”Vendor Management” open=”no”]

Power in Partnership

SCOPE has established partnerships with other service providers e.g. warehouses, logistic management companies, central laboratories, translation agencies, and CROs in selected countries. In addition, SCOPE maintains excellent relationships with third-party suppliers that bring our sponsor’s substantial benefits. We manage and contract third-party providers for eSolutions (eCRF, eDiary / eCOA, IRT and eTMF), clinical trial supplies and operational supplies. Every vendor is carefully evaluated before selection and ongoingly assessed and regularly audited.

You can count on our experienced event-management team to take care of everything for investigator and CRA meetings and congresses– from selecting guest speakers and producing conference material to booking venues and handling travel arrangements.

  • Strong partner network
  • Service budget based on realistic assessment of clients’ needs
  • Third-party provider management and assessment
  • Third-party contracting services
  • Full-service event management

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