Innovative Approaches to Integrate eSource

and IRT to Simplify the Site Experience

Presented By:

Vincent Puglia, Lead Project Manager

endpoint

Agenda

• eClinical Ecosystem

• What is eSource and Integration?

• Integrated Approach Landscape

• “All in one” vs. Integration of Specializations

• Building a Successful eSource/IRT Integrated Study

– Challenges

– Getting Started and Getting it Done

– Core Principles

– Steps Involved

• Q&A

eClinical Ecosystem

We already have a hub of integration…

Site User

IRT

Data Sciences /

Data Mgmt

Informed

Consent

LabsSite User

Site User

EDC

Site User

Site User

Unfortunately for the site user… they are it!

eClinical Ecosystem

IRT

Data Sciences /

Data Mgmt

Informed

Consent

Labs

Site User

What is eSource and Integration?

eSource and Integration

eSource Integration

What are the goals of a fully integrated

experience and what does it look like?

A Better Experience for Site Staff

A Simplified Experience

Streamlined Data Entry

Consolidated User Acceptance Testing

Less Time Spent on Training

Unified Support

Improved Study and Supply Management for Sponsors/CROs

Improved Productivity

Greater Visibility to Trends

Real-time Data

Higher Quality Data

A Vastly Simplified and Expedited Data Reconciliation Process

Improved Patient Safety

Simplified Usage

Integrated Approach Landscape

• The data-recording functions found in eSource tools are the trial-related

tasks that site staff use most often in the course of their work – like EDC –

so, it makes sense to make them the platform into which other site-based

trial tools (such as IRTs and eConsent software) are integrated to appear

embedded.

• Integrated approach does require patience, faith, and a vision.

• Current model is behind the times.

• Need to start thinking 5-10 years ahead

• Where previously (just a few years ago) technology was too complicated

or specialized, and bandwidth too narrow, to realize the promise of

integrated systems, today’s user is constantly exposed to integrated tech.

Users are ready for the workplace to catch up to home….

World We Live In – Outside of Work

• Wifi lightbulbs exist … a consumer

product .. exists as a home network.

• Automatic syncing of devices and data

such as home security and home

operations

• Seamless experience

• Accessible to most

Current Work Experience

• Segregated systems

• Multiple points entry required

• Fragmented user experience / tasks

parsed

• Large amounts of overlap that must be

reconciled

VS.

Some Foundational Elements Have Fallen Into Place

• The pharmaceutical industry is making strides toward that elusive goal as

part of a larger transformative effort to improve trial efficiency.

• The US Food and Drug Administration (FDA) went a long way towards

supporting such transformation when it published a guidance in 2013 to

“streamline and modernize clinical investigations” by promoting the capture of

source data in electronic form1 (The European Medicines Agency had

already published a position paper on the topic in 2010.)

1“Guidance for Industry: Electronic Source Data in Clinical Investigations,” FDA, September

2013

“All-in-One” vs. Integration of

Specializations

Integrated Approach is Not “All-in-One”

Are we saying that there is no place for individual expert service providers in favor of

one-size-fits-all solutions?

NO, quite the opposite.

• For this approach to be successful, none of the functionality that is otherwise

available in the separate systems can be diminished.

• In other words, the IRT integrated with the eSource system must be capable of supporting all

of the same tasks as standalone IRT systems, and it must be robust enough to

accommodate the most complex protocols.

• Additionally, you do not want to stifle innovation! New service ideas are being created all

the time, and you want to preserve the ability to invite that innovation into your ecosystem.

Integrated Approach is Not “All-in-One”

Why isn’t all under one roof the easiest way?

• While some software providers have previously attempted integrations of this

kind, they have done so by expanding their own business focus horizontally

into other types of software.

• The reality is that each type of software used to support clinical trials is very

complex and the requirements quite nuanced. They are best understood by

specialist vendors that have gained considerable experience in their own

niche.

Think of another type of highly-integrated team…

Illustration credit: http://nursingcrib.com/wp-content/uploads/sterile-and-unsterile-OR-team.gif

http://nursingcrib.com/wp-content/uploads/sterile-and-unsterile-OR-team.gif

Think of another type of highly-integrated team…

Laissez les bonstemps rouler!

Think of another type of highly-integrated team…

Laissez les bonstemps rouler!

Integration of Specializations = Success

• The only successful integration to date has

followed a partnership model in which leading

vendors of different software tools come together to

deliver their software within the eSource platform.

• In this way, each vendor is able to maintain its

specialty without dividing its time or focus, and the

resulting solution incorporates the gold standard

offering in each area.

Building a Successful eSource/IRT

Integrated Study

Challenges - So, What’s the Holdup?

The hurdles to effective integration are not always technological, but organizational and

cultural.

➢ From a technology vendor perspective, delivering on the partnership model is difficult

because it requires compromise between separate entities that are not financially connected

to one another.

➢ The outcome has to be seen as something that is greater than what either party could

achieve on its own, and the process requires a certain amount of professional trust, a great

deal of cooperation, and the irreplaceable hard work.

➢ It can also be challenging for the different parties to visualize how the individual component

systems work and to envision the final product.

Challenges - So, What’s the Holdup?

From a Sponsor/CRO perspective, interest in employing an integrated system often succumbs to inertia.

➢ Old habits die hard, particularly within the risk-averse pharmaceutical industry, and there’s a

natural tendency to want to stick with what is familiar, even if it is flawed.

➢ Given that Sponsors are already heavily invested in research and development, there’s little

appetite for taking on any additional risk from trying something new and different—until

someone else has paved the way.

➢ Regulators have not published a formal position on integrating eSource and IRT (although

the FDA and EMA both promote the use of electronic forms of data capture), and companies

are reluctant to be the first case.

➢ However, industry thought leaders have already embarked on this journey and are forming

processes, guidelines, and vendor-selection biases around the changing paradigm.

Getting Started and Getting it Done

IRT and eSource software have been

successfully integrated through the

partnership model and have been used in

multiple studies. Therefore, no company

now needs to fear being the first to employ

it. However, companies considering taking

this great step forward should lay the

groundwork for success.

Two Core Principles

Curated

Collaborative

Experience

Documentation

Core Principles: Curated Collaborative Experience

• The most important aspect of this whole endeavor is to establish a curated

experience. All information is not knowledge or insight, and this is not a call

for “pie in the sky” hand-holding and kumbaya singing!

• The knowledge base must be grown with a solid foundation, and decisions by

a core team or program executives made.

• Not every idea will be a good one, and the answer to most design questions

is not to employ endless levels of functionality which increase risk.

• You are looking to make sure the best, most potent information is being

shared (or available), but also defining the proper edges of all the innovation!

• This is a “pay it forward” system--- plan on spending a lot of time

collaborating and attending meetings.

Core Principles: Documentation

• Strong documentation of integrations, particularly API documents.

• Need a robust documentation of the integration, but it MUST be accessible to non-technical

individuals in some form.

• Strong internal documentation for technical aspects.

• Set and honor ground rules for the parties collaborating through the documents. The

receiving party has final say on the content and format.

• Strong documentation of integrations, particularly API documents.

• Need a robust documentation of the integration, but it MUST be accessible to non-technical

individuals in some form

• Strong internal documentation for technical aspects.

• Set and honor ground rules for the parties collaborating through the documents. The

receiving party has final say on the content and format.

Steps Involved

✓ Become familiar with the vendors and technologies that are available

✓ Follow the best practices of change management

✓ Limit the size of the core team overseeing the integration

✓ Consider how the integrated system will impact business processes

✓ Follow the practices of sound project management

✓ Consider your vendors for the eSource platform and IRT as partners and

consultants

Q&A

Contact Info:

Vincent Puglia

vpuglia@endpointclinical.com

mailto:vpuglia@endpointclinical.com

Notes for Reference

eSource

• A single interface at the site for data capture during the patient visit as well as other site-facing activities

provided by IRT (patient screening, randomization, and drug assignment).

• The eSource platform provides the site-facing interface, and the link to the IRT is so seamless that sites

aren’t even aware that the IRT functions are supported by a separate vendor.

• They are accessed by a single click in the eSource system and include pushbutton randomization,

dispensation, titration, etc.—no matter how complex the study.

• Sites and study management, meanwhile, have no visibility to any unblinded information unless there is

an adverse event or safety issue requiring a controlled subject unblinding.

• In such a configuration, the eSource platform manages the user’s experience in terms of the language

translations, the format, the navigation scheme, the prompts, etc.

Integration

• The integration, utilizing web services, supports real-time (low-to-no latency) two-way communication

between the applications for all patient-related functionality.

• Behind the scenes, the clinical supplies management team has access to all of the forecasting,

inventory tracking, distribution management, and reporting functions normally handled by the IRT

system.

• The core components of the integration remain in place from trial to trial, with amendments made as

needed to support the requirements of any given protocol.

• At the same time, it allows for integration with unlimited, discrete partners using the standardized

methods of communication, syntax, and common languages such as (but not limited to) XML and

JSON.

What are the goals of a fully integrated experience and what does it look like?

A Better Experience for Site Staff

• A Simplified Experience• All of the software tools that support the site’s trial work are in one place. Users have the convenience of working on a single

device with a common, user-friendly interface. They access one portal with a single logon and one password. They rely on one

help desk contact for technical support.

• Streamlined Data Entry • They no longer have to enter the same information into multiple different systems; any potential duplication is eliminated by the

vendor partners in the system build.

• Consolidated User Acceptance Testing • Because the different tools are adopted at the same time in the integrated system, the functionality is tested all at once, as

opposed to at different times.

o Less Time Spent on Training • Similarly, the training takes place at one time, and users need to learn just one system, rather than multiple ones.

• Unified Support– Sites turn to a single help desk for technical and production support.

What are the goals of a fully integrated experience and what does it look like?

Improved Study and Supply Management for Sponsors/CROs

• Improved productivity. Study managers will find all of the trial-related information they need in one place.

• Greater visibility to trends. For advanced IRT providers, data may be able to be aggregated across all trials in a clinical programs, and viewed in real

time to reveal trends in compliance, safety, and patient demand. The value of each system is amplified through comprehensive reporting that can be used

to improve patient safety, decision making, and resource allocation.

• Real-time data. Users can be notified when certain events occur or when certain thresholds are neared. This allows users to be proactive in forestalling

impending issues.

• Higher quality data. By eliminating manual and/or duplicative record-keeping at sites, an integrated system reduces the possibility of human error and

yields higher quality data.

• A vastly simplified and expedited data reconciliation process. Duplicate data points are eliminated in the system set up, and all the needed data are

stored in one place. So, redundancies, which can lead to discrepancies, are not an issue. Any necessary reconciliation can be handled as the trial

progresses, rather than after study close.

• Improved patient safety. Because study information is centralized, oversight is easier, and there is less chance that an error will slip through quality

controls. (The mobility of eSource when delivered on a tablet means that site staff can more easily check and record information as they go about their

tasks. There is less opportunity to make errors in dispensing kits, for example.)

• Simplified usage. Like site users, administrative users also benefit from having to learn and work on just one integrated system with a single sign on,

supported by a one help desk.