ScienHub Research Support
Clinical
Trials
Unit
We implement all the procedures of a clinical trial, applying strict compliance with current regulations and providing the necessary structure.
At the Clinical Trials Unit (CTU) we manage phase I, II, III and IV clinical trials, research projects, cohorts and observational studies.
We offer comprehensive support to clinical research through a standardized, excellence-oriented internal process to meet the expectations of sponsors and the research team.
Our main mission is to implement the clinical study, guaranteeing the protection of the rights, safety, well-being of the participants and the quality of the data obtained, ensuring compliance with current regulations, and adhering to the principles of good clinical practices.
Connecting science through a multidisciplinary and flexible team
Multidisciplinary Team
The added value of our unit lies in our multidisciplinary team. The team is composed of over 30 highly specialized professionals experienced in the implementation of clinical studies and from diverse professional profiles.
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Lead Study Coordinator
Project management
Supports the coordination and implementation of tools that improve the quality of procedures and results.
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Study Coordinator
Project coordination
Provides a global vision of the study guaranteeing its implementation according to the protocol.
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Recruiters
Search for participants
Pre-selects candidates and volunteers.
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Study Nurse
Performance of clinical procedures
Performs and records all clinical procedures according to the study protocol.
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Study Nurse/Technician
Management of biological samples
Manages and processes the biological samples collected ensuring their traceability.
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Data Entry
Data management
Ensures study data is correctly and timely entered in the study database from the corresponding data source.
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Clinical Trial Assistant
Clinical administrative assistance
Schedules clinical scheduling according to study protocol timepoints.
Services
From ScienHub Research Support we offer customized solutions, covering everything from full project management to targeted support for specific facets, such as:
From ScienHub Research Support we offer customized solutions, covering everything from full project management to targeted support for specific facets, such as:
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Clinical study coordination
- Coordination of all teams and services involved in the development of the study, from its start-up, after regulatory approvals, to its closure. Includes the management and implementation of studies that require blind and non-blind teams.
- Establishment of the appropriate procedures so that the observed and collected data is recorded in a reliable and accurate source documentation, providing a rigorous audit trail.
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Search for participants
- Creation of recruitment campaigns through various channels, among them, we have a web platform for the pre-selection of candidates where, voluntarily, interested people can register. The search and selection of participants is carried out exclusively by personnel with biomedical training.
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Clinical study procedures
- Performance of all necessary clinical procedures, both in cases of hospitalization, follow-up in day hospital, outpatient consultations or home visits.
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Management of biological samples
- Obtention of different types of biological samples (whole blood, urine, feces, cerebrospinal fluid), processing (ambient and refrigerated), storing them in appropriate conditions (refrigeration +4ºC, freezing -20ºC or deep freezing -70ºC) and shipping them according to IATA regulations.
- Traceability of the entire circuit from obtaining the sample to its shipment.
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Data management
- Inclusion of data in data collection electronic systems (EDC/eCRF). Experience in multiple electronic platforms, such as REDCap, Medidata Rave, Inform, Zelta, Macro or TrialMaster.
- Follow up and resolution of queries in continuous coordination with the investigator/s of the study and the research team.
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Clinical administrative assistance
- Schedule of study visits according to the protocol, including reminders of visits to ensure adherence to the schedules, as well as organizing the transportation of participants to the sites if required.
- Comprehensive billing control and budget monitoring.
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Infrastructure
- Coordination of the equipment and infrastructure needed to guarantee the appropriate implementation of research study.
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Other services
- Pharmacy specialized in clinical trials for the management of study medication and preparation of research product in a specialized room.
- Specialized unit to carry out phase I clinical trials, with the possibility of performing procedures 24 hours a day.
- Catering service adapted to the needs of the participants and study requirements.
- Performance of bone densitometries tests/ DEXA.
- Collaboration with laboratory specialized in sample processing: PBMCs, DNA, viral genotypes.
- Performing clinical study procedures at home by trained personnel.
- Carrying out procedures in the context of isolation.