Trends and Considerations in Global Infectious Disease Drug Dev | Page 13

Advanced Technology: Integrated Digital Platforms

Figure 11.

Benefits of TEMPO

The FDA, (EMEA), and other regulatory agencies, such as MHRA,
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are placing greater responsibility on sponsors to take a more proactive
approach to clinical development to ensure compliance and mitigate
risks. The 2011 FDA guidance and EMEA guidance on trial oversight
encourage greater reliance on automated, remote monitoring practices
to improve data quality and ensure subject protection. The agencies
also promote a more systematic, risk-based approach to monitoring,
combining centralized and on-site monitoring.
Centralized monitoring and management systems support site selection,
investigator and patient recruitment, and patient registration; monitor
patient quality throughout the study; analyze site performance, evaluate
individual subject data, and report site and data trends and problems.

external data reconciled with clinical data. A centralized system fully

For infectious diseases, the system looks at demographic and feasibility

integrates the spectrum of clinical trial functions in a single platform so

metrics to identify the best time and place for trials. EDC platforms with

all stakeholders access the same information in the same format at any

rapid data access facilitate triggered monitoring that alerts monitors

time. The digital platform stores all documentation, including safety and

to safety and data quality issues. The increasing size and complexity of

virology information as well as microbiological evidence of treatment

clinical trials, coupled with the urgency and often narrow window of

success, such as eradication of the baseline pathogen, providing a com-

time for many infectious disease studies, make advanced technology

plete review of patients and a robust picture to evaluate study endpoints

platforms essential in global drug development. Sponsors and clinical

more rapidly.

research organizations (CROs) have been increasingly embracing
Internet-enabled technologies, such as electronic data capture (EDC)

Replacing the costly traditional model of onsite visits every four to eight

and fully integrated clinical trial management and monitoring systems,

weeks and 100 percent source document verification is a risk-based

to ensure quality of data and clinical trial conduct and gain needed

monitoring system that supplements onsite visits with centralized,

efficiencies. EDC enables rapid data collection and sharing in

targeted monitoring to focus on the data most critical to study outcomes.

multinational trials that must manage large patient databases

The system should provide more timely data tracking, automated risk-

across multiple international study sites.

based key indicators reporting with workflows and alerts to enable
proactive decision-making by the clinical teams and medical monitors.

Advanced systems, such as TEMPO™ eClinical and TEMPO™ Trial

This is critical in monitoring the performance of sites before repetitive

Manager, provide complete integration of data and importation of

errors are made.

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