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2) 228 Avenue Souffleur , Flic en Flac , Mauritius
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Africa’s Most Respected CEO 2022
(Pharmaceutical & Biotechnology)
Health Revelation Women in Africa
(WIA 54) 2021 Laureates
Trending to a new norm: From on-site to Remote management and monitoring
Remote Start Up Activities
Submission to the Authorities, Ethic Committee
Perform feasibilities, Pre study visits and Set up activities
Internal project management
Prepare financial/administrative agreements with study sites
Site management including initial and continuous training (GCP, protocol and amendments) of site staff and monitoring of progress proactively
Preparation and maintenance of study related files.
Handling of reported AE, SAE and endpoint according to guidance documents and procedures.
Budget and resource planning and follow up of the clinical study.
Advantages
Improve recruitment.
Reduced time for submission.
Better oversight on the on-site study progress and holistic assessment of clinical trial data
Ensures ongoing TMF Quality Checks
Maintain profound knowledge in the study documents and procedures throughout the study.
Centralised Monitoring
100% SDV reviewed remotely by our in-house CRA.
Creation, management, updating and Quality check of TMF
Creation and review of remote study management tools and logs to have an oversight on the on-site study progress and perform a holistic assessment of clinical trial data
Remote training of the site staffs
Focussing on KRIs, missing EDC and laboratory data, Data trends and integrity ,status of patient informed consent within and across sites
Select sites and/or processes for targeted on-site monitoring
Advantages
Helps in early identification and mitigation of data quality risk/issue(s) which may compromise validity of study results.
Supports in better monitoring of patient safety and helps in enhancing subject protection.
Increases effectiveness of CRAs during on-site monitoring.
Creates overall efficiencies in clinical trial operations.
Mitigate study and site risk with secure, remote monitoring of critical documents to help keep your trials running smoothly. Assist sites and monitors in secure document acquisition, task workflow automation, and Source Document Review (SDR)
Telemedicine
Creating connections- engaging patients with Investigators and treating physicians
Balancing trial participation and life
In a hybrid or a fully decentralised study, you’re less worried about finding the right doctor and more interested in finding the location with the most potential patients and then supporting the principal investigator in recruitment.
Advantages
Patient-centric and researcher/physician-centric
more accessible, more comfortable and more efficient trials and in some cases safer