SCOPUS is a Clinical Arm of “Science in Action” research organization that offers a broad range of clinical development services in all stages and aspects of study design.
Our scientific background and “hands on” experience to design, develop and execute early as well as advanced clinical development programs allow you to increase efficiencies, reduce timelines and costs and to realize the full potential and value of your product.
Our service packages are flexible and agile and perfectly tailored to your needs.
Scopus global infrastructure and support allow us to collaborate with opinion leaders and to conduct clinical trials across EU (Eastern and Western), US, Latin America, China and Hong Kong.
CLINICAL & REGULATORY
SUPPORT
INDUSTRY EXPERTISE
Our clients and partners include medical device, pharmaceutical and biotechnology organizations.
We help to accelerate the process of bringing your new product to market with the experience, resources and global reach of SCOPUS team.
CLINICAL EXPERTISE
Project phase:
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Medical devices: First in Human (FIH), pivotal studies
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Pharmaceuticals: FIH, Phase I-IV
Indications:
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Medical devices: Orthopedic, Digital Health-related products, Non-invasive as well as High risk (Class III, PMA) devices
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Pharmaceuticals: Oncology, Oncology-Pediatric, Psychiatric, Gastroenterology, Neurology, Hepatic, Cardiology, Diabetic, Orthopedic, Rheumatology
CLINICAL SERVICES
We work according to current ICH-GCP requirements, all applicable local and global laws and guidelines.
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Medical writing –
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Investigator’s Brochure (IB)
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Study Protocol
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Case Report Form (CRF)
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Informed Consent Forms (ICF) and all submission package forms
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Clinical Study Report
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Regulatory services –
we take care of all your study’s regulatory processes, including Institutional Review Board (IRB)/Ethical Committee (EC) and Competent Authority (CA) regulatory submissions
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Clinical development –
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Feasibility and site selection
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Site contract and budget negotiations
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Study file set-up
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Establishment of Standard Operating Procedures (SOPs)
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Clinical contract overview
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Monitoring - we provide consistent and effective monitoring and interaction with study sites
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pre-study visits
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site initiation visits
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on-site monitoring
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site closure visits
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Project Management –
we focus on providing on-time, on-budget, quality deliverables.
Contact us, we want to work with you
Contact details for Clinical Services:
Luba Shapiro
Mobile: +972-54-2222054
Email: luba.shapiro@mail.com