Improved technology adoption and clinical operations processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time Monitoring that is dramatically changing the way we interact with our trial sites.

1. 5 key reasons to make the move to Just-in-Time Monitoring Carla Radke, BS, RN, CCRP Laurin Mancour, CCRA, CCRP, RAC Mark Shapiro, MA, MBA, CCRA, RAC February 24, 2010

2. Today’s webcast will cover Our 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-up Study Analysis Study Planning Study Reporting Study 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 early Just-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 sites Just-in-Time monitoring is a vehicle to change the nature of the monitor-site relationship First, focus on well-performing sites They will get you your patients and they will appreciate your support Just-in-Time Monitoring is Less disruptive to site’s clinical activities and obligations Proactively identify issues and change behaviors, prior to the visit Consistent communication with sites and greater support More and more monitoring activities can be done remotely and be less disruptive to the site

7. Focusing on Ethics and Regulatory Compliance With 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 visits Focus on more complex protocol-related issues and deviations Increased time available for ethical and regulatory compliance reviews Increased time available for site training and re-training Tools and technology promote compliance by design Edit checks promote protocol adherence Reports 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 TRAVEL More site transparency = less travel = happier monitors Happier monitors = less employee turnover Remote data monitoring permits less rushing, on-site Faster source document verification when on-site Reduces the number of queries and protocol deviations Learning curve for each new protocol Supported by a database that accounts for subject selection criteria that anticipates outliers as potential deviations

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

10. Initiate early to enroll more As 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 sites Scheduling 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&A CLINIPACE.COM Carla S. Radke {cradke@clinipace.com} Laurin Mancour {lmancour@clinipace.com} Mark Shapiro {mshapiro@clinipace.com}