1. Key Considerations for Report Generation & Customization Richard Wzorek Director, Production IT Confidential © Almac Group 2012

2. Agenda Introduction Review the Pros and Cons of Varying Report Types The Effects of Downstream Workflows on Reporting Standards Levels of Reports Customization Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting Q&A

3. Introduction Q: Why is report customization an important topic? –A: 85-90% of a sponsor user’s time within an IVR/IWR system is spent in reports Q: Who can be impacted by reports customizations and the information they produce? –A: Clinical team, operations, data management, informatics, logistics, etc.

4. Introduction Q: What impact does reports user roles play in implementing customizations? –A: Reports have some of the highest potential for multi- patient unblinding when the wrong user role is assigned Q: How is the information in the report used? –A: This is crucial to flesh out during requirements to ensure usability

5. Introduction Review the Pros and Cons of Varying Report Types The Effects of Downstream Workflows on Reporting Standards Levels of Reports Customization Unique trial designs that require heavily customized or ad-hoc reporting Q&A

6. Categories of Reports Static flat reports –A report that outputs fixed results and offers little to no dynamic adjustments (i.e., PDF files, Excel spreadsheets, HTML) Dynamic flat reports –A report that outputs fixed results and offers dynamic filtering and sorting (i.e., web reports that require input form the user before they rerun) Fully interactive reports –A report that supports filtering, sorting, grouping, drill down, and drill through (i.e., a web based dashboard)

7. Static Flat Reports Easy requirements acquisition process and training Reports will generate the same output (format & content) Good for situations where the data will be imported into a downstream system or process PROS Lack of flexibility Often require post live amendments A sponsor will often require a large number of these type of reports to address their needs CONS

8. Dynamic Flat Reports The ability to dynamically filter reduces the number of report needed Data can be exported as static and some of the after export effort is reduced Output format stays consistent PROS More involved requirements acquisition process Increased need for user training Data must be modeled correctly to ensure high performance CONS

9. Fully Interactive Reports The user can identify and focus on outliers quickly Ability to “drill” into details in real time Filtering and sorting are context sensitive PROS Requirements acquisition requires more engagement Requires more training and burn in time Requires data to be modeled and pre- aggregated to deliver high performing reports CONS

10. Introduction Review the Pros and Cons of Varying Report Types The Effects of Downstream Workflows on Reporting Standards Levels of Reports Customization Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting Q&A

11. Effects of Workflow How is the information in the report used? Results viewed on the screen drive real-time actions in the IVR/IWR system Printed and brought into meetings Saved to PDF and emailed to a distribution list Exported to excel and additional information and formatting is added Exported to excel and the results are added into another spreadsheet or system

12. Effects of Workflow Exported to excel and the results are imported into another system Should this be a data transfer or integration? Exported to excel and additional information and formatting is added What are the chances of manual errors? Saved to PDF and emailed to a distribution list Should this be an automated process? Printed and brought into meetings A report is the correct tool Results viewed on the screen drive real-time actions in the IVR/IWR system

13. Effects of Workflow Understanding how the reports and the information they provide are used will pave the way to achieving effective standardized reporting. Reduced study level customizations Easier requirements acquisition process Reduced need for re-training on every study Effective Standardized Reporting

14. Introduction Review the Pros and Cons of Varying Report Types The Effects of Downstream Workflows on Reporting Standards Levels of Reports Customization Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting Q&A

15. Types of Customizations Simple Customizations Using the standard or core reports offered with the small changes necessary to make them work with the specific protocol. These types of changes do not typically necessitate changes in reports standards. Examples: Addition and removal of data points Changes to static sorting Changing labeling of data points, etc.

16. Types of Customizations Moderate Customizations Using a standard or core report with more than 30% of the functions within the report changed. These types of changes may necessitate changes in reports standards to help contain costs. Examples: Changes to the way the data is grouped Adding custom calculations Using custom sort lists, etc.

17. Types of Customizations Custom Reports This entails starting from scratch or customizing more than 50% of the functions within the report. These types of changes should drive standards discussions. This is the most important area to understand the differences between needs and wants. Examples: Custom dashboards Repurposing part of a report Predictive analytics

18. Introduction Review the Pros and Cons of Varying Report Types The Effects of Downstream Workflows on Reporting Standards Levels of Reports Customization Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting Q&A

19. Ad-hoc Reporting Q: Do I need Ad-hoc reporting capabilities? –A: With a well defined and built suite of interactive reports this will most often not be necessary. Q: How do I know when this functionality will be needed? –A: In data collected from over 500 trials, the biggest users of Ad-hoc functionality are from global logistics when they are working across a large program of studies.

20. Unique Trial Designs & Reporting Multiple treatment arms with each arm having a different visit schedule Adaptive trials that add or drop treatment arms Unique cohort management methods Complex site and IP hierarchy –Sites: Region, Cluster, Country, Site –IP: Lot, box, kit, vial

21. Key Takeaways Understand the workflows the data within the reports will be used to support Ask yourself who needs to be involved in reporting requirements acquisition Balance cost savings and value when determining the correct solution

22. Thank You!