The Wellcome HRB CRF provides a bespoke service to Clinicians and Pharma-companies to ensure their studies are conducted to the highest regulatory standards ensuring patient safety and data integrity.
The Wellcome HRB-Clinical Research Facility literally provides a one stop shop for all your research needs. Below is a list of the services we provide you can opt for full project management or just select the services you require:
Project Management and Coordination
We can provide full project management support and coordination for your study from early feasibility stage all the way through to study close out.
Research Nursing support
We provide dedicated highly skilled research nurses to work with you on your study in terms of patient selection, patient recruitment, patient follow-up and education, protocol related activities, liaising with Sponsor and CRAs.
Our research nurses will ensure patients are booked in for appointments, provide patient education, safety and support.
Laboratory Support Services
Our on-site staffed laboratory will be able to process all study biospecimens in accordance to regulatory and protocol requirements. We will ensure bloods are shipped off to central labs under IATA regulations. We work under biosafety containment Level 2.
Our on-site data management team can assist with data entry onto the electronic case report forms (eCRF). We have experience in all the current eCRF platforms.
Our on-site staffed pharmacy can support all your needs from oral dispensings to complex aseptic compounding.
Quality and Regulatory Support
We will ensure that your study is conducted in accordance to ICH-GCP and the highest regulatory standards.
Monitoring visit support
We have an on-site monitoring room for CRAs and monitors. Our research nurses will liaise closely with Pharma companies following up on monitoring visits and ensuring the study is inspection ready at all times
In the event of a HPRA inspection we will guide investigators through preparation for this, provide a venue to conduct the study and follow up in relations to CAPAs
Budget negotiation and contracts
We can complete full study costings using validated costing templates and ensure contracts are negotiated at a fair rate.
We can assist with study invoicing as per contract
Ethics and HPRA submissions, follow-ups, protocol amendments etc
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