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.