The document discusses the benefits of just-in-time monitoring in clinical trials, emphasizing its potential to enhance efficiency, reduce costs, and improve site relationships. By shifting from a fixed schedule to an event-driven approach, trials can identify issues early and maintain better compliance with ethical standards. Additionally, this method promotes remote monitoring, reducing travel for clinical research associates and ultimately leading to higher job satisfaction.

1. 5 key reasons to make the move to Just-in-Time MonitoringCarla Radke, BS, RN, CCRPLaurin Mancour, CCRA, CCRP, RAC Mark Shapiro, MA, MBA, CCRA, RACFebruary 24, 2010

2. Today’s webcast will coverOur goal today is to discuss what Just-in-time Monitoring is and how it can help:

3. Why are we here?Clinical trials are complex [and expensive], and good monitoring can positively impact on site performance, timeline, and budget.Study Start-upStudy AnalysisStudy PlanningStudy ReportingStudy Execution!!!!!!!!!!Moving to Just-in-Time Monitoring can make a significant impact on study execution

4. What is Just-in-Time Monitoring?Just-in-Time monitoring is changing the paradigm for monitoring visit frequency from an elapsed duration (monitor the site every eight weeks) to an event-driven paradigm (monitor the site after the first and every third subject is enrolled or in the event of a protocol deviation). Just-in-Time monitoring is only possible with the use of EDC and the corresponding ability of CRAs to monitor the sites remotely (review enrollment, subject data, and queries) on a regular basis.

5. Detecting and addressing problems earlyJust-in-Time monitoring helps to keep trials on track and reduce or mitigate certain trial risks. It can impact many trial metrics.

6. Strengthening relationships with trial sitesJust-in-Time monitoring is a vehicle to change the nature of the monitor-site relationshipFirst, focus on well-performing sitesThey will get you your patients and they will appreciate your supportJust-in-Time Monitoring isLess disruptive to site’s clinical activities and obligationsProactively identify issues and change behaviors, prior to the visitConsistent communication with sites and greater supportMore and more monitoring activities can be done remotely and be less disruptive to the site

7. Focusing on Ethics and Regulatory ComplianceWith Just-in-Time Monitoring, more site time can be spent ensuring the trial is ethically executed and appropriately-documented.Transparent access to study data enables monitors to identify issues, prior to study visitsFocus on more complex protocol-related issues and deviationsIncreased time available for ethical and regulatory compliance reviewsIncreased time available for site training and re-trainingTools and technology promote compliance by designEdit checks promote protocol adherenceReports allow you to identify deviations and ensure proper AE reporting

8. Avoiding CRA stress and burnout#1 Reason CRA’s say they quit their job? TOO MUCH TRAVELMore site transparency = less travel = happier monitorsHappier monitors = less employee turnoverRemote data monitoring permits less rushing, on-siteFaster source document verification when on-siteReduces the number of queries and protocol deviationsLearning curve for each new protocolSupported by a database that accounts for subject selection criteria that anticipates outliers as potential deviations

9. Let’s run the numbers, reducing trial costsConsider the following hypothetical Phase II study scenario:

10. Initiate early to enroll moreAs would be expected in a competitive enrollment study, sites that were initiated early enrolled more subjects.

11. This graph shows the total number of hours required to monitor all subjects at each site under the three monitoring paradigms.Capacity more closely aligned to enrollment

12. Stop over monitoringpoorly enrolling sitesScheduling monitoring based on elapsed time (q4 or q6 weeks) leads to less efficient deployment of resources than JIT monitoring at lower enrolling sites.

13. Efficiency creates capacity

14. Q&ACLINIPACE.COMCarla S. Radke {cradke@clinipace.com}Laurin Mancour {lmancour@clinipace.com}Mark Shapiro {mshapiro@clinipace.com}