Key Considerations for Report Generation & Customization

Richard Wzorek

Director, Production IT

Confidential © Almac Group 2012

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

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.

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

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

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)

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

PROSLack 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

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

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

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

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

Effects of Workflow

Exported to excel and the results are imported into another systemShould 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 listShould this be an automated process?

Printed and brought into meetingsA report is the correct tool

Results viewed on the screen drive real-time actions in the IVR/IWR system

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

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

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.

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.

Types of Customizations

Custom ReportsThis 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

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

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.

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

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

Thank You!

Q&A