Preparation and responding to Feasibility studies from NIHR, Sponsors and CROs and AROs
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Run-in preliminary data searches for feasibility studies
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Completing expression of interests for feasibility studies and sharing them with respective parties (NIHR/Sponsors/CROs/AROs) within the given time periods
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Communication with NIHR/ Sponsors/CROs/AROs in early study start up (site set up, equipment set up)
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Facilitating preliminary non-disclosure agreements signing between sponsor and the research site
Budget preparation, budget negotiations and contract finalization
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Responsible for budget preparation and review
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Budget negotiations with relative parties (NIHR/Sponsors/CROs/AROs)
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Negotiating contracts for services and data transfer agreements and finalizing the agreements on behalf of sponsors/CROs/AROs and the research site and reviewing
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Facilitating the execution of the contracts
Project Management Activities
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Facilitating study start up meetings with the research team to plan and ensure to meet / exceed KPIs delivery on the project.
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Preparation and facilitating for Site Evaluation Visit (SEV), Site Selection Visit (SSV) and Site Initiation Visit (SIV)
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Pre-screening using EMIS (electronic data base), clinic appointments and repeat prescriptions.
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Calling, discussing, and scheduling appointment with trial subjects
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Assisting in Informed Consent process
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Preparation of source notes for PI review and signature
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Maintaining patient files with study visits and updating the EMIS on the study visits
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Reviewing Medical history
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Assisting Physical examination
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Reviewing concomitant medication
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Recording demographics
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Measuring weight and height (BMI if required)
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Measuring vital signs (BP, pulse, temperature, respiration)
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Dispensing standard agent or IMP/NIMP
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Drug accountability and compliance
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Concomitant medication check throughout the study
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Review/reporting of patient AEs/SAEs
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CRF/eCRF completion including data transferring
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CRF /eCRF query resolution
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Use of IVR/IWR
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Coordinating and supporting Principal Investigators and Sub Investigators to successfully carry out the trials
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Arranging and facilitating progress review meetings with the study team on study management and routine activities
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Facilitating invoicing Sponsor/CROs/AROs on behalf of research site for research related activities
Managing Unscheduled Activities
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Urinalysis (dipstick)
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Specimen dispatch by post/courier
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Collection of equipment/ medication
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Assisting monitoring on-site visits or risk/remote based monitoring
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Telephonic follow up / surveillance with trial patients
Communication with Sponsors/CROs
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Coordinating and reporting to study CRO and Sponsor as per the communication protocols
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Preparation for the CRO / Sponsor audit and audits by regulatory authorities
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Follow up and implement corrective actions arraign from audits
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Ensuring that the necessary supplies and equipment for a study are in stock and in working order
End of study activities
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Query resolution in eCRF/CRF within the timelines before data analysis by CROs/Sponsors
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Facilitating master drug accountability and liaising with sponsors/CROs/AROs drug destruction protocols
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Facilitating eCRF signing off by principal investigators before database lock
Set up and Close down activities
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Assisting archival of all study documents
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Assisting in feasibility questionnaires
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Dispensary based dispensing.
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IMP management (temperature recording)
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Receiving shipment
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Packing returns for return to sponsor
Recruit Medical Professionals to NHS From Sri Lanka
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We are officially approved by International Recruitment and listed on the Ethical Recruiters List (Since December 2023) as a recruitment agency to recruit medical professionals from other eligible countries to serve NHS.
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This service will be started soon in the early quarter of 2024.