Advance Monitoring in Clinical Trials.

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Advanced monitoring in clinical trials involves the use of various tools, techniques, and strategies to ensure the safety and efficacy of experimental treatments while minimizing risks and maximizing benefits for study participants. This approach goes beyond traditional monitoring methods, such as on-site visits and source data verification, to include more innovative approaches that rely on technology and data analytics. One such technique is remote monitoring, which allows for the collection of data in real-time from study participants using electronic devices, such as smartphones or wearable sensors. This allows researchers to closely monitor participants without requiring them to visit the study site regularly, reducing the burden on both patients and study staff. Advanced statistical methods can be used to analyze this data to identify any potential safety concerns or adverse events. Another approach is risk-based monitoring, which involves using a risk assessment to identify the areas of the study that are most likely to have issues and focus monitoring efforts in those areas. This approach allows for a more targeted and efficient monitoring strategy, saving time and resources while still ensuring participant safety. Advanced monitoring may also involve the use of centralized monitoring, where a team of experts remotely review study data and identify any issues or trends that may require additional investigation. This can include data management errors, protocol deviations, and safety concerns.

Healthcare

Welcome
ADVANCED MONITORING IN CLINICAL TRIALS
TADDI RAJA
M.Sc MICROBIOLOGY
044/032023
5/6/2023
www.clinosol.com | follow us on social media
@clinosolresearch
1

INDEX
•Monitoring of clinical trials
•Advance Monitoring of clinical trials
•Risk Based Monitoring of clinical trials
•Digital monitoring of clinical trials
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CLINICAL TRIAL MONITORING
● Monitoring of clinical trials is mainly by Traditional
process & Advanced process
●Traditional process involves on-site monitoring
● Advanced monitoring involves off-site monitoring,
and cross-site monitoring by using well-advanced
technology.
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ADVANCE MONITORING OF CLINICAL
TRIALS
● Advanced monimonitoring of clinical trials involves
in use of up process technologies
● Clinical trials are evolved based on the technology-
based clinical trial monitoring
● Risk-based monitoring/centralized clinical trials &
Digital/virtual (Decentralized) clinical trials are
recent trending types in advanced monitoring of
clinical trials
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RISK BASED CLINICAL TRIAL MONITORING
●This is centralized monitoring of clinical trials
suggested by FDA.
●The Data can be kept updated with a regular check
for completeness& consistency.
● Centralised monitor is always having updated
information for all sites
● Trend analysis, identification of noncompliance &
in-house review are possible
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DIGITAL/ VIRTUAL CLINICAL TRIAL
MONITORING
●Remote monitoring is the future of clinical research which
involves Decentralized monitoring.
● FDA has encouraged the use of technology, noncontact
drug delivery, and telehealth in clinical trials and these will
reshape the future of clinical research
● Using mobile/ Digital technology in clinical trials has
helped trials become more efficient on every level
● Virtual trails are making participation more accessible
especially for this who live in rural areas & have mobility
issues.
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BENIFITS/USES
● Enhanced review process
● Cost-effective
● Fast & effective decision making
● Time-saving
● Cross site comparative study
● Increased patient enrollment
● Reduce patient dropouts
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Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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