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
- Improve recruitment.