“Expertise is far more
than just know-how.”

Klaus-Peter Barth, Director Operations

OUR EXPERTISE

SCOPE International has forged long-term relationships with well-known companies in the pharmaceutical, biotech, biosimilars, medical device, diagnostics, generics and functional food sectors, and has gained considerable experience in conducting phase IIa – IV clinical studies, non-interventional studies and post-marketing surveillance.

We have the benefit of established ties with renowned life-science companies, universities and hospitals, as well as long-term personal contacts with a wide range of clinical sites and patient advocacy groups. Thanks to our professionalism, we are highly regarded amongst investigators and sponsors for our experienced monitoring teams and proactive project and site management.

OVERVIEW THERAPEUTICS

Our expertise is a guarantee for your success

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YOUR PARTNER FOR ALL AREAS
OF CLINICAL DEVELOPMENT

SCOPE International info graphic clinical study phases

OUR RANGE OF EXPERTISE

Whatever your project, SCOPE’s team of expert staff specialise in providing a complete service that is 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, SCOPE has conducted over 250 studies with 65,000 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.

SCOPE 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. Our understanding of the requirements 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 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.

SCOPE 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 have performed trials in the key indications of Pain, Respiratory, CNS, Gynaecology and Immunology, with our studies having included over 2,700 subjects. Our network of specialist paediatric investigators and sites, coupled with our extensive know-how in paediatric regulation and documentation makes it so that SCOPE can handle every aspect of your trial.

Clinical trials for rare diseases present particular medical, scientific and operational challenges. SCOPE enjoys close relationships with key investigators – an absolute must for successful recruitment of patients and subjects. In addition, SCOPE has established liaisons with patient support groups and subject recruitment experts for clinical trials. Our access to proprietary databases and feasibility studies makes us the perfect partner for any orphan drug trial.

SCOPE 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, as well as oncology. In addition, SCOPE has managed clinical trials for laboratory developed tests (LDTs) and assay platforms. SCOPE is 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, 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.

To discuss how we can support your project or for further information on our experience by indication:

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WOMEN’S HEALTH

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PAIN

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RESPIRATORY

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NEUROLOGY

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ATMP

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