Support and management for pediatric clinical research
RECLIP offers a broad portfolio of high quality services based on trial-ready sites infrastructure across our specialized network throughout Spain.
At RECLIP, as a national hub, we offer support for study initiation and management of clinical trials, from site assessment, selection and identification of sites, strategic country feasibility activities, to core documents collection services or budget support and contracts management.
The services of RECLIP are aimed at customers from the biopharmaceutical industry as well as researchers and networks from the non-commercial, academic sector.
Services offered include consultancy and support for all levels of pediatric clinical trials from Planning & Preparation to Implementation & Trial Management, but also a Single Point of Access (SPA) to coordinate sites and to channel and speed up the access to the service.
RECLIP works in close collaboration with patients and parents representatives to align strategies and trial designs with the real needs of children and families or caregivers.
The RECLIP Service Portfolio has been built around four different categories aimed to serve all stakeholders involved in pediatric clinical trials.
Single Point of Access (SPA)
Channeling of all incoming requests for their management, with the aim of speeding up access to the corresponding service and the coordination of the sites-
Project Management support during all phases of trial conduct.
Planning & Conduct of Clinical Trials
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Site assessment, selection and identification of sites
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Identification and selection of patients
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Strategic country feasibility activities
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Expert Review & Advice Support to Clinical Development Plan or Pediatric Investigational Plan
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Study Protocol Development
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Expert Review & Advice Support to Clinical Development Plan or Pediatric Investigational Plan
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Core Documents collection services
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Budget support and Contracts Management
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Management and study of Regulatory Submissions (Ethics Committees and National Competent Authorities/Regulatory Agencies)
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Peer-to-Peer Strategy Services (advice on innovative recruitment strategies)
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Training & educational services and sharing of best practices from Quality Assurance.
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Design and implementation of SOPs (Standard Operating Procedures) according to protocol specific requirements
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Compilation and review process of essential documents for Site Activation (electronic format)
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Support and follow up during site training activities (GCPs, SAEs, Crisis Resource Management, etc)
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Coordination and alignment of internal communication activities among the study participating sites (recruitment strategies, study protocol procedures, mentoring of less experience sites)
General Services
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Translation, adaptation, and interpretation support of clinical trials documentation (posters, leaflets, etc)
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Identification of Pediatric Networks and relationship brokerage
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Establishment of professional connections beneficial to pediatric scientific communities, healthcare professionals, and the general population
Science & Medical Communication & Adhoc services
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Technical writing and editing on clinical trials related documentation
Also, specific and customer-tailored services can be fully designed, such as the development of strategy for identification / referral of patients from RECLIP network sites to active sites for the study.
Endorsements from RECLIP
We can evaluate and perform scientific endorsement for activities in the field of pediatric clinical research, aiming to serve as a verification and validation of the content of the program or specific activity, as publications (guides, documents, books) and other initiatives or dissemination projects such as webinars, conferences or congresses.
If you are a promoter of a scientific activity involving pediatrics and are really looking for value-added endorsement from RECLIP, contact us through our mailbox.
Membership packages
We offer interested academic institutions and companies, both industry sponsors and CROs (Contract Research Organizations), different levels of membership models and fees. If you are interested, we would be pleased to hear from you. For speficic requests, please contact us.