ScienHub Research Support
Contract
Research
Organization
We provide 360º support to researchers/sponsors throughout the process of a clinical study, guaranteeing the quality and efficacy of the results obtained.
We are an Academic Contract Research Organization (CRO). We support clinical trials with medicines for human use, research with medical devices, observational studies with medicines and research projects. We act as a liaison between researchers/sponsors, ethics committees, regulatory agencies, providers and participating centers.
Our main mission is to provide support in all procedures related to the submission, documentation, start-up, development and completion of a clinical study, guaranteeing the quality and effectiveness of the results obtained.
Connecting Science,
implementing quality research
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:
-
Initial project management
The preparation of a research project is a highly complex task requiring specific knowledge and coordination of multiple actions that must be carried out in an orderly and timely manner.
- Drafting of protocols, participant information sheets, informed consents and required study documentation
- Selection of participant centres and key personnel
- Design of Research Electronic Data Capture (EDC) / Electronic Case Report Forms (eCRF)
- Design and preparation of study files and documentation
- Insurance Policy Management
- Drafting of study manuals and necessary standard operation procedures (SOPs)
-
Bureaucratic procedures
In a highly regulated environment such as clinical research, it is essential to have an up-to-date knowledge of the legislation and regulations, as well as the bureaucratic requirements and regulatory procedures to follow.
- Preparation of all the necessary documentation
- Initial submission to regulatory entities for approval (Ethics Committees, Autonomous Communities, CTIS, AEMPS)
- Negotiation of the site contracts
- Submission of Relevant protocol modifications
- Study notifications to regulatory bodies
-
Monitoring
Monitoring visits to the participating study sites from the initiation, during and at the closing of the project by specialized personnel (CRA- Clinical Research Assistants) are essential and necessary to ensure the results and the quality of the research.
- Initiation visits
- Monitoring visits
- Monitoring visits to pharmacy
- Closing visits
- Remote monitoring visits
- Support to participating sites
- SAE (Serious Adverse Events) Management
-
Project management
Clinical studies are usually long-term projects that require continuous and methodical monitoring to ensure that the objectives and timings are met according to the protocol and / or that in case of deviation and unforeseen events the necessary actions are timely taken.
- Coordination and support throughout the development of the clinical study
- Clinical trial registration in www.clinicaltrials.gov and REEC
- Drafting Relevant protocol modifications
- Medication supply management
- Management of study payments
- Sample Management
- Coordination of researchers’ meetings
- Study follow-up reports
- Publication of the results in EudraCT
-
Data management
The data management area covers all those tasks necessary to ensure that the data collected within the framework of the project is of quality, reliable and traceable.
- Creation and design of database, Research Electronic Data Capture (EDC) / Electronic Case Report Forms (eCRF)
- Centralized randomization
- Data validation
- Query generation and management
- Data base lock and closure
- Reconciliation of adverse events
-
Other services
Other areas involved in conducting clinical studies and in which we can provide solutions and assistance are:
- Statistics
- Pharmacovigilance
- Final reports
- Translations