Whatever your project, SCOPE’s team of expert staff specialise in providing a complete service, tailored to your needs – whether it’s a clinical trial, post-authorisation study, rescue study or even a complex device or diagnostic combination or adaptive trial. We have the experience, know-how and resources to guide you smoothly through all development phases. In business since 2000, we have conducted over 200 studies with 40,000 patients worldwide. We have offices in 17 countries across Europe, Russia, Ukraine and the U.S. with 250 permanent employees – and with our partner network, we are operational across all continents and markets wherever patient populations are located.
Contact Scope International to discover how we can support your project.
Non-interventional Studies/Post-authorisation studies
Scope International is involved at every stage of the clinical trial process – from managing initial development and interventional studies (phases IIa – IV) to non-interventional, post-authorisation studies (PAS), including safety and efficacy studies. We have considerable experience across the therapeutic spectrum, handling drug, diagnostic and device trials and our understanding of what’s required for post-approval studies and pre-approval development has contributed significantly to numerous product approvals.
With constantly changing national regulatory requirements and ethical codes, there is no overall international standard for non-interventional studies (NIS). Despite the considerable challenges, Scope International can design your NIS to meet any necessary regulations wherever you’re operating in the world, while ensuring your goals are met and costs kept in check.
Contact us to discover how.
Paediatric trials and investigation plans
Scope International has considerable experience in managing paediatric trials (from neonates to adolescents) and in developing paediatric investigation plans (PIPs) across a wide range of indications: From phase IIa to IIIb we performed trials in the key indications of Pain, Respiratory, CNS, Gynaecology and Immunology including more than 2,700 subjects. With our network of specialist paediatric investigators and sites and our extensive know-how in paediatric regulation and documentation, we can handle every aspect of your trial.
Clinical trials for rare diseases present particular medical, scientific and operational challenges. Scope International enjoys close relationships with key investigators – an absolute must in recruiting patients and subjects. In addition SCOPE has established liaisons with patient support groups and subject recruitment experts for clinical trials. With our access to proprietary databases and feasibility studies, we are the perfect partner for any orphan drug trial.
Contact Scope International to discuss your needs with one of our experts.
Scope International’s team has managed device clinical trials for asthma, chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), acute hypercapnic respiratory failure, respiratory viral infections (RSV) in children and adults, respiratory bacterial infection in children, and oncology; as well as laboratory developed tests (LDTs) and assay platforms. We are familiar with international and national requirements for medical devices including: ISO 14155, US-FDA CFR Title 21, 93/42/EEC Medical Device Directive, German MPG (Medical Device Act) and the MPKPV Ordinance concerning Medical Devices, the UK MHRA, and the Australian TGA Essential Principles.
We support all stages of strategic planning, Notified Body selection, regulatory body pre-consultation, engagement, and submissions, budgeting, trial design, and all operational aspects of your clinical trials. This includes first-in-man (FIM), pilot, pivotal, and post-market clinical trials in support of traditional market clearances such as CE Marking, Investigational Device Exemption (IDE), 510(k) Premarket Notifications, Premarket Approval (PMA) applications, Humanitarian Use Device (HUD), and Post-Market Follow-up Study (PMFS) requirements, but can also include Humanitarian Device Exemption (HDE), Expanded Access / Compassionate Use, Emergency Use, and Expedited Pathway Access (EPA), approaches. Additionally, we offer consulting to support your grant, literature review, clinical evidence generation, reimbursement, market adoption, and publications programs.
Contact Scope International to discuss your device trial.