Pharma intelligence

RELEASING THE BRAKES:

How New RTSM/IRT
Solutions Will Accelerate
Drug Development

IN PARTNERSHIP WITH

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 TABLE OF
CONTENTS
03 Foreword

04
CHAPTER 1:
The Challenges Faced By
An Industry In Flux

06
CHAPTER 2:
Why A New Approach
To RTSM/IRT Is Needed

CHAPTER 3:

08 How Technology Must Change To

Meet The Needs Of The Industry

11 CHAPTER 4:
How RTSM/IRT Can Accelerate R&D

© 2018 by Informa Business Intelligence, Inc., an Informa company. All rights reserved. No part of this publication may be reproduced
in any form or incorporated into any information retrieval system without the written permission of the copyright owner
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 PHARMACEUTICAL COMPANIES TODAY invest to each other” and now actually contribute to

FOREWORD
billions of dollars in the development of a single overall process inefficiency with redundancy
innovative new medicine. That investment, and manual effort slowing things down. One
along with the competitive nature of the area particularly affected by this fractured
business and the urgency to deliver treatments environment is drug randomization and supply
for patients in need, puts companies under management.
enormous pressure to reduce the time it takes
to bring a new drug to market. As Oracle continues to advance solutions
for clinical development, we wanted to
In turn, this puts a great deal of focus understand more precisely where the specific
on the evolving clinical trial process and pain points exist for our customers. We
the technology that supports it. Pharma worked with Pharma Intelligence to survey
companies are demanding that clinical professionals in the field and learn more about
operations teams move much faster, despite their needs, specifically around randomization
the fact that trials have become more and supply management.
numerous and more complex than ever.
First and foremost, clinical study teams told us
As Oracle continues For example, telemedicine has made the they are frustrated with the lack of integration
development of the “site-less” clinical trial between their Randomization and Trial Supply
to advance solutions for possible, where the trial goes to the patient Management (RTSM) systems and other clinical
instead of the patient going to the trial, and platforms. They’re also concerned about the lack
clinical development, where wearable sensors play a big role in of flexibility their systems have when it comes to
we wanted to providing far more data about those remote implementing mid-study changes – and almost
patients than ever before. Medicines based everyone we surveyed told us they typically deal
understand more on immunotherapy, genomics and other with one or more such study changes that slow
scientific advances are changing the nature the process by weeks. Understanding these
precisely where the of trials even further, but also make it more frustrations is the first step in meeting the
challenging to identify, recruit and maintain needs of the industry in the future.
specific pain points the proper patient cohorts. And on top of
this, regulators around the world continue Our goal in conducting this research was to
exist for our customers. to issue new guidelines for clinical trials ensure we are addressing the top challenges
STEVE ROSENBERG
design, conduct, and reporting that must be of our customers and delivering what the
SENIOR VICE PRESIDENT
incorporated into the process. market wants in a modern RTSM solution.
AND GENERAL MANAGER,
That’s not only good for our customers it’s

>>>
ORACLE HEALTH SCIENCES
While technology vendors have stepped up to great for the ultimate beneficiaries of clinical
support the needs of the various teams involved trials: Patients. The more we can help clinical
in clinical development to improve efficiency trials move faster in a safe and effective
over the past 20 years, this innovation has manner, the more we accelerate the pace of
taken place in functional silos. The result is a new medicine and as millions of patients wait
collection of point solutions that don’t “talk with hope for the next innovation.

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1
THE CHALLENGES
FACED BY AN
INDUSTRY IN FLUX

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 POWERFUL FORCES ARE RESHAPING CLINICAL TRIALS.
Faced with the urgency to advance new therapies to meet the needs
of patients, beset by generic competition and pricing pressures,
sponsors are running complex studies designed to differentiate their
innovative drug candidates from the pack. In theory, these trials
should be getting faster and more efficient due to the availability
of more data and technology. Yet, the ubiquity of silo’ed eClinical
systems that don’t easily connect to each other means this theory is
yet to translate into practice.

>>>
One point solution developed with the goal to
improve efficiency was Randomization and
Trial Supply Management (RTSM).
>>>
The struggle to leverage technology that truly meets the needs of
today’s trials underpins some of the industry’s problems. At a time
when other sectors are reaping the productivity-boosting benefits
of technology, the pharmaceutical industry is seeing the inflation-
adjusted cost of drug development double every nine years1, which
neutralizes the positive impact of process improvement. With
clinical trials accounting for two-thirds of the cost and duration of
R&D,2 it is clear where a big part of the problem lies. It’s not that
the technology to support clinical trials doesn’t exist; the issue lies
in the lack of advancement of that technology to meet the needs of
today’s clinical trials. Legacy clinical trial technologies were created
as point solutions to manage specific parts of the trial process
independently, which at the time was a big improvement over
manual processes, but didn’t have the big picture in mind. Over time,
organizations tried to stitch these point solutions together to create referred to at times as Interactive Response Technology (IRT). And
a more connected process, but as a result they actually created new while RTSM/IRT solutions have saved companies time and resources
barriers to achieving efficiency and speed. by automating the randomization of patients and supply of study
drugs, the current technology isn’t meeting the needs of today’s
One point solution developed with the goal to improve efficiency clinical trial supply managers and clinical operations teams. It’s time
was Randomization and Trial Supply Management (RTSM), also for technology to catch up to the critical needs of the industry.

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2
WHY A NEW APPROACH
TO RTSM/IRT IS NEEDED

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 THE SHORTCOMINGS OF RTSM/IRT SOLUTIONS STEM FROM
the pace of change in the clinical trial sector, which is designing and
running increasingly complex studies that require highly-flexible
technologies. These changes have created a disconnect between
what study teams need and what RTSM/IRT solutions can provide.

This disconnect is evident in results from a recent survey of

professionals in clinical operations, trial supply management
and related functional areas. The survey conducted by Pharma
Intelligence and Oracle Health Sciences sought to understand the
frustrations clinical teams have with existing RTSM/IRT systems,
and what they want and need from this technology to make their
job easier.

>>>
92% of clinical teams need to update their IRT
systems due to minor trial amendments such as
new inclusion criteria, the reliance on vendors
ties their hands and delays their studies.
>>> RTSM/IRT vendor to make the changes. With 92% of clinical teams
needing to update their IRT systems due to minor trial amendments
Integration emerged as the biggest issue, with 74% of respondents such as new inclusion criteria, the reliance on vendors ties their
saying it is challenging to connect their RTSM/IRT systems to other hands and delays their studies.
eClinical platforms. Sponsors want the vast array of technologies
now needed to design and run clinical trials to connect to each The reliance on vendors creates other issues, too. Most respondents
other easily and seamlessly, removing the redundancies and manual cited the review and validation process, the time needed to build, test
effort currently required to manage a trial. While, vendors have tried and deploy technologies, and reliance on vendors to perform these
to integrate these siloed systems, the survey suggests these efforts tasks as significant challenges with their existing RTSM/IRT solutions.
have failed to fully address the problems.
These problems have real impacts. The survey results suggest it
Respondents also zeroed in on shortcomings of RTSM/IRT solutions typically takes 6.5 weeks to build, deploy and validate an RTSM/IRT
themselves. Many of these issues are interrelated. For example, 71% solution, with some respondents indicating that they have waited
of people cited a lack of flexibility and inability to support study more than 10 weeks for a vendor to complete these tasks. These
changes as a top pain point. This frustration is tied to the fact that prolonged timelines have multiple detrimental effects, from delays
today’s systems are not self-service, and sponsors need to ask the to the start of clinical trials to a reduction in overall clinical trial activity.

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3
HOW TECHNOLOGY
MUST CHANGE TO
MEET THE NEEDS OF
THE INDUSTRY

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 TECHNOLOGY SHOULDN’T CREATE PROBLEMS;
IT SHOULD SOLVE THEM.

RTSM/IRT technology solved some significant problems when it was

first introduced in the 1990s. It represented a great advance for the
industry, streamlining what, until then, had been a highly manual
process, by automating it and moving it online. These new RTSM
platforms reduced paperwork and cut the time required to set up
and implement a study. However, these platforms were developed
as independent point solutions at a time when there were far fewer
demands on the clinical trial process, and far fewer trials overall.

>>>
Fundamental to our approach is providing
capabilities rather than systems.
>>>
Today, research-based pharma companies have close to 15,000
products in their pipelines; and, the nature of the products and the
supporting clinical trials are likewise more complex. That’s led to to be captured once and common tools that can be used across all
the problems identified in the survey -- problems that legacy RTSM processes.
platforms can’t address.
Fundamental to our approach is providing capabilities rather than
The finding of the research suggest the industry needs a fresh, new systems. This allows things to be broken down into smaller modules
approach to how technology supports clinical trials – not tied to the that remove the complexity required by a systems approach. By
limitations of the past, and considering the technology innovation unifying those capabilities into a single platform, Clinical One
available today and in the future. As the leading eClinical provider eliminates the interoperability and integration problems that affect
in the market, backed by the development teams of the second- legacy RTSM technology.
largest software company in the world, Oracle is well-positioned to
answer this call. Oracle Health Sciences is leading the way in “next The RTSM function is critical to getting a trial up and running, so
generation” clinical trial technology with the recent launch of its new with that in mind, Oracle developed the randomization and supplies
Clinical One Platform. With Clinical One, Oracle Health Sciences has management module of the Clinical One platform first (Oracle Health
reimagined the way technology and information are used in clinical Sciences Clinical One™ Randomization and Supplies Management
research. It provides universal access to information that only has Cloud Service). In the near future, the electronic data capture module

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 will be layered on to the RTSM foundation already built in Clinical One.
Knowing that the industry can’t make the switch to a highly innovative
solution like Clinical One overnight, Oracle has ensured that this new
technology can integrate not only with legacy RTSM systems, but
with other legacy clinical trial solutions as well, including EDC and
CTMS systems to name a few. This way organizations can transition
to a modern eClinical environment, smoothly and at their own pace.
This approach is enabled with cloud technology supporting a single

>>>
Study teams can manage studies themselves in
real-time through the 100% self-service platform
and intuitive user interface of Clinical One.

>>>
data model for Clinical One. Data is entered once and then made
available to all the other modules and their users, as needed, at
every step in the clinical trial process. This makes it possible to create
a study in which patient data capture and management, study
design, site management, screening, inclusion/exclusion criteria,
protocol deviation, adverse event reporting management and more
are shared across all functional areas and teams involved in a study.
Clinical One Randomization and Supplies Management Cloud without causing disruption of the trial. It also makes possible a
Service is a versatile solution. Study teams can manage studies future where clinical trials are conceived and implemented in new
themselves in real-time through the 100% self-service platform and ways – for example, by randomizing a patient even before they see
intuitive user interface of Clinical One – from initial study design a clinician, or allowing patients to “see” investigators remotely and
and start-up, to mid-study changes – or; they can leverage the shipping drugs directly to the patient, supporting the advent of
vast experience of Oracle’s team to assist with the design, build the “site-less” trial.
and deployment of their studies. Having these options enables
organizations to focus on their expertise and get studies up and Clinical One represents a significant re-imagining of clinical trial
running as quickly as possible. technology, not only RTSM, but the entire clinical trial process. This
new approach will restore the promise of technology to speed clinical
With Clinical One, it has become possible to reduce the study start trials—not slow them—which will help get new therapies to market
up times from weeks to days, and to support mid-study changes faster for patients in need.

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4
HOW RTSM/IRT CAN
ACCELERATE R&D

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 A BETTER, FASTER APPROACH TO RTSM/IRT WOULD LEAD
to significant improvements in clinical trials. If a drug goes through
five clinical trials on its path to market, a sponsor could spend one
year working with vendors to build, deploy and validate RTSM/IRT
solutions. Even if each deployment was faster than is typical today,
the sponsor could still spend more than six months on RTSM/IRT
tasks for a single drug.

That creates an opportunity for RTSM/IRT solutions that are quicker

to set up to have a real impact on clinical trial timelines. Self-service
RTSM/IRT systems are expected to cut setup times from weeks to
days. Scaled across a clinical development program, such time

>>>
Sponsors that adopt next-generation RTSM/
IRT systems stand to control R&D spending
while accelerating and expanding
development, enabling them to get more
life-changing medicines to market.

>>>
savings would result in therapies getting to market many months,
perhaps even a year, sooner. These savings benefit patients and
the finances of drug developers.

Following the ripple-out effects of these efficiency gains shows the

benefits could be even more far reaching than anticipated from
a preliminary analysis. Notably, two-thirds of survey respondents
said cutting RTSM/IRT timelines from weeks to days may enable
them to run more clinical trials. In this way, new RTSM/IRT systems
will do more than accelerate drug development. They will expand
its frontiers.

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 Empowered by self-service RTSM/IRT systems, sponsors may have
the resources to run more clinical trials. One sponsor could run
a somewhat-speculative trial in a different indication, creating a
chance to address an unmet need and open up a new market for
a therapeutic. Another sponsor may allow more assets to advance
into human testing, minimizing the risk that resource prioritization
will cause effective drugs to languish in its preclinical portfolio.

>>>
This app-enabled approach has
multiple upsides. Site staff equipped with
RTSM/IRT mobile apps will enter data into
the system faster, cutting the risk that
administrative backlogs.

>>>
All these gains stem from one improvement to RTSM/IRT systems,
namely the shortening of setup times. Other improvements will unlock
additional gains. Making RTSM/IRT systems part of larger eClinical
platforms is expected to simplify integration — resolving the biggest
pain point identified by survey respondents — while eliminating data
duplication and allowing for one-time entry of data across sites. These
improvements will free sponsors to focus time and resources on drug
development instead of low-value process and admin work.

The rise of mobile technology will lead to additional benefits.

Today, it’s typical for staff at a clinical trial site to manually update
RTSM/IRT systems when study drugs arrive, are dispensed or are
returned. Mobile apps could automate these data entry tasks. All the
information about a medication kit is held in its barcode. Scanning
the barcode with a camera on a mobile device could allow site
staff to pull up all of this information and update the status of the
associated medication kit in the RTSM/IRT system.

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 This app-enabled approach has multiple upsides. Site staff equipped with RTSM/IRT
mobile apps will enter data into the system faster, cutting the risk that administrative
backlogs will negatively impact the operational efficiency of the study center, and by
extension, the progress of the trial. The automation of data entry will also dramatically
cut the likelihood of errors, that inevitably occur with manual human effort, that
could lead to participants receiving the wrong study medication.

The currently available RTSM/IRT systems make it possible for medication errors to
happen. One study found the average annual error rate in a clinical trial was 0.35%.3
With the United States Food and Drug Administration calculating that more than
100,000 people participated in pivotal clinical trials alone in 2015,4 cutting the error
rate could stop hundreds of patients from receiving inappropriate and potentially
dangerous doses every year.

SUMMARY
In these ways, next-generation RTSM/IRT solutions stand to pull off the rare feat of
making a system both faster and safer. Having made do with solutions that lagged
behind their needs for years, sponsors can now look forward to using RTSM/IRT
systems that keep pace with their requirements and thereby eliminate many of
the challenges they have faced in recent years.

These systems will feature the simple plug-and-play connectivity sponsors want,
ending the long wait for interoperable eClinical technologies. The systems will also
be more flexible and give back control to the trial teams. Instead of having to wait
for vendors to set up the system and make mid-study amendments, sponsors will
be empowered to make the changes themselves. Many of the pain points identified
by the surveyed clinical trial professionals will fade away once these RTSM/IRT
solutions are adopted.

The scale of the broader challenges faced by the industry means these improvements
cannot come soon enough. Sponsors that adopt next-generation RTSM/IRT systems
stand to control R&D spending while accelerating and expanding development,
enabling them to get more life-changing medicines to market. Oracle Health Sciences provides the only eClinical platform made up of best-of-breed
solutions powered by the #1 data and cloud technology in the world. With Oracle H
 ealth
>>> Sciences, Life Sciences organizations can manage and unify all elements of the C
 linical
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 eing open,
PULSE The Biopharmaceutical Investment & ication Errors in a Clinical Trial of an Inves- IN CLINICAL TRIALS REPORT. Available at:
1. Scannell, J. W., Blanckley, A., Boldon, H. Competitiveness (BCI) Survey – 2015. Avail- tigational Parenteral Medication. Contemp https://www.fda.gov/downloads/Drugs/ collaborative and adaptive to change.
& Warrington, B. Diagnosing the decline in able at: https://www.pugatch-consilium. Clin Trials Commun 4, 64–67 (2016). InformationOnDrugs/UCM570195.pdf.
pharmaceutical R&D efficiency. Nat. Rev. com/ reports/BCI%202015%20-%20Measur- (Accessed: 27th August 2018)
Drug Discov. 11, 191–200 (2012). ing%20the%20Biomedical%20Pulse.pdf. To learn more about Oracle Health Sciences visit: www.oracle.com/healthsciences
(Accessed: 27th August 2018)

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