Clinical Operations

Superior processes from start to finish

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.

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

We rely on 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 whose work is backed by the entire team’s joint experience and resources. The oversight and management of your study is coordinated through our in-house KaleidoSCOPE system. 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.

Study road mapping

Time after time we discover 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 strategies developed to mitigate them. We consider this as a crucial assessment especially for country and site selection, for estimating time as well as costs and for 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

Proactive study management – we are with you all the way

Our approach is very ‘hands-on’ – reacting quickly and managing proactively to make your business our business. We provide a single point of contact to coordinate for you all involved parties –the operational teams, third-party vendors and study sites 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
  • KaleidoSCOPE project platform for continuous process optimization and transparency, with continuous 360° project overview
  • Flexible capacity to fit your needs

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 its local monitoring teams with experienced clinical research associates (CRAs), closely managing site performance to avoid protocol violations, maintaining low query rates and ensuring study enrolment as well as on-site logistics.

Scope International deploys teams of local office-based, permanent CRAs from national offices providing a cost effective solution. Consistently 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.

All our CRAs have considerable clinical research expertise, broad therapeutic experience and strong communication skills that are vital for good site-sponsor relationships.

At Scope International, we believe that clinical operations is not only about making sure that the project runs smoothly through high quality monitoring and management, but also about delivering personalised service. Selected for their strong interpersonal skills, our CRAs build close site and sponsor relationships.

Our site management process ensures fast, proactive support that you and 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 the recruitment strategy. They maintain close personal contacts to identify and solve any potential problems and to 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 study documentation
  • Patient recruitment strategies

Partnership power

Scope International has established partnerships with other service providers e.g. warehouses, logistic management companies, central laboratories, translation agencies, CROs in selected countries; as well as excellent relationships with third-party suppliers that bring our sponsors 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, then continuously assessed and regularly audited.

For investigator and CRA meetings and congresses, you can count on our experienced event-management team to take care of everything – 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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