2024

Pharma GUIDE

Research
Services
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Content
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It all starts with a conversation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Research-backed reliable, accurate, and valid COAs are just the beginning. . . . . . . . . . . . . 5
We are your one-stop shop for Pharma services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 – 7
Strategic partnerships. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 – 9
What are Clinical Outcome Assessments?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 – 11
FAQs: Licensing with Pearson. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 – 13
FAQs: Translations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 – 15
FAQs: Additional Services. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Featured research. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 – 19
Thought leadership. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 – 21
Growth Scale Values (GSVs). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 – 23
Exploring optimal protocol outcomes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
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Research-backed reliable,
accurate, and valid COAs
are just the beginning

Are you looking for a partner for your clinical trials?

You’ve come to the right place!

Our pharma research team includes experts in the fields of clinical practice, test development,
and psychometric analysis. Our goal is to support you in assessing the efficacy and safety of
therapeutic treatments and provide the highest level of customer service in scale licensing,
translations, scientific consultation, and rater training.

Wherever you are in your trial-planning journey, we will be with you every step of the way!

Supporting clinical research with an 80-year history

in measurement science

Get connected to a comprehensive portfolio of research-based instruments that are

psychometrically validated, reliable, and represent the highest technical quality in Clinical
Outcome Assessments (COAs).

“At Pearson, we can help identify which COA best fits the trial design,” says Lynsey Psimas,
Ph.D., director of sales and pharma services. “Our COA portfolio includes reliable and valid
PRO, ClinRO, ObsRO, and performance measures used by pharmaceutical, biotech and medical
device companies conducting clinical research.” Pearson is particularly noted for our proven
and trusted assessments in cognitive ability, memory, neuropsychology, behavior, personality/
psychopathology, achievement, and speech/language.

Our COA portfolio includes reliable and valid PRO, ClinRO, ObsRO, and
performance measures used by pharmaceutical, biotech and medical
device companies conducting clinical research.”

Discover more about Pharma Research Services.

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PearsonAssessments.com

It all starts with

a conversation
Meet your team of experts

J. Lynsey Psimas, PhD Paul Williams, PsyD

Director of Business Development Account Manager

Dr. Psimas is a Licensed Clinical Dr. Williams has extensive experience

Psychologist with extensive experience in providing a variety of mental health services
the assessment of children, adolescents, including neuropsychological assessment
and adults. She has worked in private and psychotherapy with a specialization
practice, therapeutic schools, and in adolescents. He came to Pearson
as a professor. She specializes in in 2002 as a Senior Research Director,
neuropsychological assessment, autism, leading several teams in the development
ADHD, and learning disabilities. of a variety of assessments including the
Bayley™, WISC®, and WAIS®.

None of the advancements in medicine that eradicate, treat, and cure

our illnesses and progressive diseases would make it into the hands of
those who need them without the validation of your clinical trials. We
understand that the tests you use in those trials need to be built with the
same rigor as the research behind the novel treatment options that are
being tested — and they need to be reliable.”
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Jarett Lehner Katrina Bengtson

Account Manager Account Manager

Prior to joining Pearson, Jarett worked as Katrina joins the Pearson Pharma
a Psychometrist at an outpatient mental Team with a background in Clinical Trial
health clinic in Minneapolis, Minnesota, Management and Psychometry expertise.
where he administered psychological Prior to Pearson, Katrina worked in
and neuropsychological assessments. Pharmaceutical Clinical Operations
Jarett joined Pearson’s Training and specializing in study start-up at a Clinical
Implementation team and served as a Research Organization. Katrina gained
national trainer for the Q-global® and familiarity with the Pearson Assessments
Q-interactive® platforms before moving from her time as a Psychometrist
to the Healthcare and then Pharma conducting neurocognitive evaluations at
Sales teams. the Anschutz Medical Campus in Colorado.

Pearson’s vast catalog of Clininical Outcome Assessments (COAs) have

been proven reliable through decades of research and are suitable for a
wide range of ages with norms that reflect today’s population.“

Complete the Request a Consultation form to get connected with one of us.
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We are your
one-stop shop
for clinical
endpoints

We are here to support you and your

needs throughout your clinical journey.
From training and consultation to
translations and eCOA migration,
we have got you covered.

Rater Training
Get expert training straight from the source.
Let us support you with rater training for your
Clinical Outcome Assessments (COAs). Our
experienced training team includes psychologists
and clinical practitioners with expertise in clinical
endpoints, psychometrics, and e-learning to
ensure standardized administration and scoring.

Raters will be armed with the most up-to-date

and valid administration and scoring guidance.
Training content will be tailored to meet your
needs. Rater training is available to CROs and
Sponsors in a variety of formats, including in-
person training, virtual sessions, and on-demand
training modules to support your clinical trial.

Contact us for more

information and pricing.
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Scientific consultation
Maximize your data analysis efforts
As data analysis and clinical endpoint questions
arise, let our pharma experts help you find the
answers. Our team of scientists have expertise
in clinical practice, test development, and
psychometric data analysis. Scientific Consultation
is tailored to meet your needs.

We are here to provide unique and additional

insights that your researchers need to effectively
detect treatment changes. Our experts can
provide guidance on topics including:

• COA endpoint selection

• Scale licensing
• Data analysis
• Growth Scale Values (GSVs)
• Preparation for FDA submissions
• Out-of-level testing

Contact us for more

information and pricing.
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Strategic partnerships
Get more access to the resources you need for your clinical trials.

Decades of experience have shown that the best way to support our Pharma partners
is working across the industry to provide you with more access to the assessments
and resources you need for upcoming clinical trials. Our partnerships with MHS and
Lionbridge make this possible!

MHS
You can now license MHS assessments through Pearson.
Multi-Health Systems Inc. (MHS) is a leading publisher of scientifically validated assessments
for more than 30 years. MHS serves clients in educational, clinical, corporate, public safety,
government, military, pharmaceutical, and research settings

Contact us for scale availability or visit our

partnership page for additional insight.
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Lionbridge
We partnered with Lionbridge for their expertise in translations and eCOA migration.
Lionbridge has over 25 years of experience with translation and localization projects
across the globe. Lionbridge has a proven track record of translating all types of Clinical
Oucome Assessments (COAs) into the language you need for your clinical trial.

What this means for you:

• Error-free translations
• 350+ languages supported
• On-time deliverables and on-time in-full deliveries
• ISO compliant linguistic resources
• Conceptual equivalence to the original instrument
• Comparability across languages and cultures
• Access to linguists across the globe to ensure accuracy of translations

Visit the partnership page.

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What are Clinical

Outcome Assessments?

What are clinical outcome assessments?

Clinical Outcome Assessments, also known as COAs, are standardized questionnaires/
assessments that are used to collect patient experience data such as disease symptoms,
treatment side effects, or how symptoms impact quality of life.

Expand your Pharma vocabulary

Here are some commonly used acronyms and their meaning:
1. P
 atient-reported outcome (PRO): patient self-report
• For example, the (ex. Beck Depression Inventory, Beck Anxiety Inventory)
2. C
 linician-reported outcome (ClinRO): report by a clinician
• For example, the PANSS (Positive and Negative Syndrome Scale)
3. O
 bserver-reported outcome (ObsRO): report by a caregiver/parent
• For example, the Vineland Adaptive Behavior Scales, Third Edition
4. P
 erformance outcome (PerfO): tasks performed by a patient under the instruction
of a clinician/healthcare professional.
• For example, the Bayley Scales of Infant and Toddler Development or the
Wechsler Family of Assessments
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FAQs:
Licensing with Pearson

Q: How long does it take to obtain a license agreement?

Your dedicated Account Manager will email you an Intake Form to identify key components of
your study. After reviewing the form, they will schedule a Discovery call to discuss the study, your
assessment needs, and gather any additional information needed to more forward with your
license agreement.

Pearson will then conduct an internal audit of our existing Intellectual Property (Published US
English, Certified Research Translations, and International Publications). For any scales that
require translation, Pearson will work on your behalf to obtain a translation quote. All details,
including pricing and translation timelines, will be integrated into a Statement of Work (SOW).
Please know a Master License Agreement (MLA) must be in place prior to executing a SOW.
Learn more about licensing here.

Q: When do I need a license agreement?

For published tests that require no adaptations or modifications, you may purchase off-the-shelf
test kits for which your Account Manager can help you obtain a quote. For content that will be
modified, you will need a license agreement.

Q: What is considered a modification?

Any change made to the originally published format of an assessment is considered a
modification and requires a license to proceed (Ex. Inclusion in eCOA, eCRF, Digitization,
Adaptation, Translation, headers, footers, etc.).

Q: Where can I find pricing?

Please contact your Account Manager or Submit an Inquiry here to obtain pricing for published
COAs, certified research translations with a Certificate of Translation, and/or initiating new
translations. Review the general fees on our website.

PearsonAssessments.com/Pharma
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Q: Which languages are available?

Many of the assessments that we offer are available in a wide variety of languages, and your
Account Manager will be able to provide you with availability. If we do not have an International
Publication or Certified Research Translation available, Pearson will work with our exclusive
translation vendor to obtain the translations you require.

Q: Which languages can I use in each country?

Pearson does not provide guidance regarding which languages should be used in specific
countries. It will be up to your study team to determine whether additional languages are
appropriate in your research study.

Q: What is Pearson’s signatory process?

Once an agreement is ready for both parties to sign, it is Pearson’s policy for the other party
to sign the agreement first and then return the partially executed agreement to Pearson for
electronic signature. Our legal team will be copied to facilitate the signatory process (lsr-XXXX).
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FAQs:
Translations

Q: Can I translate Pearson COAs?

No. Pearson oversees all translations of Intellectual Property to ensure the quality and
content meets our standards. You will be provided with a Certificate of Translation for all
research translations.

Q: How long will my translation take?

Translation timelines vary based on the scope of your project, requested languages, and
features of the COA(s) selected. You will receive an estimated delivery timeline on your
Statement of Work.

Q: What is the difference between an ”International Publication” and

a “Certified Research Translation”?
A published scale published scale has been normed, standardized, and commercialized for
use in a specific geography and language. Based on the rigorous validity studies to determine
lingustuc and cultural equivalence of an international publication, these scales are not
accompanied by a Certificate of Translation. All psychometric data can be found in test manuals.
Certified Research Translations are trans-adaptations based on an English source file. Trans-
adaptations are aligned with industry guidance and best practices and recommended by
regulatory bodies (FDA, EMA, ISPOR, C-Path PRO and ePRO Consortia, ISOQOL) to ensure a high-
quality, valid, and localized translation.

Q: Why doesn’t my published clinical outcome assessment (COA) include

a Certificate of Translation?
Pearson Clinical Assessment international publications are developed in accordance with
the caliber defined by the International Test Commission (ITC) Guidelines for Translating and
Adapting Tests (second edition, 2017). The guidelines apply to both the translation of items
and content, and adaptation to cultural and construct relevance within a particular region. It
is imperative to note that adaptation refers to a multitude of activities including modification
of the test format. The professional standard is to determine whether a test in one language
and culture can successfully measure the same construct in another. Therefore, item content
included in an international publication may not be parallel to the English version.
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Q: Are internationally published assessments identical to

US English published assessments?
Pearson Clinical Assessment international publications are developed in accordance with
the caliber defined by the International Test Commission (ITC) Guidelines for Translating and
Adapting Tests (second edition, 2017). The guidelines apply to both the translation of items
and content, and adaptation to cultural and construct relevance within a particular region.
The professional standard is to determine whether a test in one language and culture can
successfully measure the same construct in another. Therefore, documents published in English
may not directly align with international publications. Should your study team determine that
you require a translation parallel to the English version, please work with your Account Manager.

Q: How will my files be delivered?

All published content and Certified Research Translations are delivered in electronic format via
Box.com. The licensee on the account will receive an email notification that files are available.
You will receive files in PDF format, along with any associated Certificates of Translation (available
only with Certified Research Translations).

Q: Does Pearson require eCOA migration and Screenshot review (SSR)?

Yes. When a Sponsor wishes to adapt “paper” COAs for use on an electronic data collection
platforms (ePRO/eCOA), Pearson’s Translation Support team will work with our exclusive
translation vendor, the eCOA provider, the Licensee to facilitate this process.
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FAQs:
Additional Services

Q: How do I get a quote for physical kits?

Contact your Account Manager or email [email protected] to obtain
for physical testkits and paper materials.

Q: Can I get watermarks for Pearson’s IP?

Pearson will provide English watermarks. Non-English watermarks are currently not available.

Q: Do you offer consultation?

Yes. Pearson offers Scientific Consultation tailored to meet your needs. Our training teams
expertise in clinical practice, psychometrics, and e-learning ensures standardized administration
and scoring. The training team consists of seasoned psychologists and clinical practitioners
familiar with issues related to clinical assessment in the research and healthcare space. Fees
may apply.

Q: Do you offer rater training?

Yes. Pearson works with CROs and Sponsors to support rater training, which can be delivered in
various formats including in-person, virtual, and on-demand training modules. Training content
can be tailored to meet your needs.

Our training team’s expertise in clinical practice, psychometrics, and e-learning ensures
standardized administration and scoring. The training team consists of seasoned psychologists
and clinical practitioners familiar with issues related to clinical assessment in the research and
healthcare markets.
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Featured research
See how our clinical outcome assessments (COAs)
are being used in today’s research.

Bayley Scales of Infant and Toddler Development™

The Association between Bronchopulmonary Dysplasia Grade and Risks of
Adverse Neurodevelopmental Outcomes among Preterm Infants Born at Less
than 30 Weeks of Gestation
This study seeks to quantify the risks of unfavorable neurodevelopmental
outcomes for each bronchopulmonary dysplasia (BPD) grade in preterm
infantes delivered at less than 30 weeks of gestation. Researchers evaluated
infants who received care until at least 36 weeks postmenstrual age and
had a rigorous neurodevelopmental assessment using the Bayley Scales
for Infant and Toddler Development (BSID) in our infant follow-up clinic.
Using descriptive statistics and regression methods, they examined the
relationship between BPD grade and unfavorable neurodevelopmental
outcomes.
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Beck Anxiety Inventory® (BAI®)

The Association between Physical Activity and Anxiety in Aging:
A Comparative Analysis
As the world’s population ages, there is a greater need to recognize the
significance of physical activity in the anxiety of older individuals. The
objectives of this study was to analyze anxiety in older adults who engage
in physical activity and those who do not. Questions were included from
the Beck Anxiety Inventory, BAI, and the Physical Activity Inventory for Older
People. The sample data of this study contribute to the conclusion that
physical activity influences anxiety levels with 98% certainty, and it is advised
that future studies with other designs be added to it.

Beck Depression Inventory® (BDI®)

Distorted Thoughts as a Mediator of Depressive Symptoms in Patients
with Major Depressive Disorder: A Longitudinal Study
Over a six-month period, this study sought to determine whether distorted
ideas mediate depressive symptoms in Major Depressive Disorder
MDD patients. The Hamilton Depression Rating Scale (HAMD-17), the
Montgomery-Asberg Depression Rating Scale (MADRS), the Beck Depression
Inventory (BDI-II), and the Depression Thoughts Scale (DTS) findings were
gathered at weeks 1, 8, 12, and 24. Cognitive distortions were found to be
a mediator of depressive symptoms, emphasizing the necessity of early
psychological therapies in MDD patients who present these distortions.

Positive and Negative Syndrome Scale (PANSS) and

Repeatable Battery for the Assessment of Neuropsychological
Status Update (RBANS)
Differences in Inflammatory Marker Profiles and Cognitive Functioning
between Deficit and Nondeficit Schizophrenia
The purpose of this study was to investigate the differences in cognitive
functioning and plasma levels of C-reactive protein (CRP) and inflammatory
cytokines between deficit schizophrenia (DS) patients, nondeficit
schizophrenia (NDS) patients, and healthy controls (HCs). To assess
clinical symptoms and cognitive performance, the Positive and Negative
Syndrome Scale (PANSS) and the Repeatable Battery for the Assessment of
Neuropsychological Status (RBANS) were utilized.
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Vineland Adaptive Behavior Rating Scale, Third Edition

TM

Use of the Vineland-3, a Measure of Adaptive Functioning, in CLN3

Early and frequent signs of CLN3 disease include neurocognitive
impairment and progressive visual loss. This emphasizes the importance
of neurodevelopmental functioning for the illness but restricts the range
of neuropsychological tests. The Vineland-3’s connections to the well-
established results of verbal IQ (VIQ) and Unified Batten Disease Rating Scale
(UBDRS) indicate its convergent validity for use in CLN3. Future longitudinal
studies will be crucial to proving the Vineland-3’s usefulness for tracking
change in CLN3, including replication in other cohorts and evaluation of
sensitivity to change.

Wechsler Adult Intelligence Scale (WAIS)

WAIS®5
Wechsler Adult Intelligence Scale® Longitudinal Study of Epigenetic Aging and Its Relationship
FIFTH EDITION

with Brain Aging and Cognitive Skills in Young Adulthood

This study investigated epigenetic aging during adolescence and young
adulthood and assessed its associations with brain aging and cognitive
outcomes in a longitudinal study of a prenatal birth cohort. In the late 20s,
cognitive abilities were measured using the Wechsler Adult Intelligence Scale
(WAIS).

Wechsler Intelligence Scale for Children (WISC)

Network Analysis of ADHD Symptoms and Cognitive Profiles in Children
In this study, using a network method, researchers systematically examined
the cognitive profiles and ADHD symptoms of the patents and discovered
a number of relationships between these two categories. The WISC-IV
was administered to each participant. The full-scale intelligence quotient
(FSIQ), verbal comprehension index (VCI), processing speed index (PSI), and
working memory index (WMI) scores of the ADHD youngsters in our sample
were lower. Academic ability, inattention symptoms, and mood disorder all
exhibited direct interaction with the cognitive domains of the WISC-IV among
all the core symptoms and comorbid symptoms of ADHD.
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Thought
leadership
Stay up-to-date on news Pharmaceutical
to the Pharma and clinical trial space
and read our Featured Articles on
BioPharma Dive!

How the right technology and tools

can accelerate progress in rare
disease clinical trials

Rare diseases, defined as occurring in fewer

than one in 2,000 persons, affect more than
300 million people worldwide, with the majority
having significant unmet medical requirements.

The need for greater research into rare diseases

is obvious, but researchers confront major
hurdles, from recruiting individuals with one
of the 7,000 different rare diseases to picking
meaningful endpoints and making conclusions.
Technology has paved the way for increased
liklihood of success in clinical trials.

Read the article

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3 ways decentralized clinical 5 steps to help increase the

trials could help advance odds of clinical trial success
research on rare diseases
Pharmaceutical businesses must stress
According to the National Organization for clinical trial validity in order to ensure that
Rare Disorders, one out of every ten people the findings are relevant and applicable to
in the United States is affected by a rare patients in real-world clinical settings, as
disease. Despite this, only about 5% of the well as that the data can survive heightened
7,000 diagnosed rare diseases have an FDA- scrutiny by regulatory bodies.
approved treatment.
However, among the most common reasons
Wearable technology, mobile health apps, clinical trials fail include inability to establish
telemedicine, and a variety of information efficacy, safety concerns, challenges with
technologies have all become commonplace inclusion and exclusion criteria, and patient
in people’s daily lives. Dr. Lynsey Psimas recruitment. Read about the five measures
explains why decentralized clinical trials that can improve the chances of a successful
are becoming more widely accepted, how clinical trial.
they might benefit patients with uncommon
diseases, and promote research into these Read the article
illnesses.

Read the article

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GSVs
What are Growth Scale Values (GSVs) and how can they
improve precision in research?

In testing and in research, it is critical to have both an effective and reliable way to measure
change. The traditional accepted metric for research studies has been age equivalents (AEs)
and raw scores. However, the lack of standard deviations, standard errors of measurement, and
equal intervals between scores, make AE’s imprecise. While raw scores have typically been the
go-to to measure change, GSVs are quickly becoming the preferred method.
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GSVs in simple terms

GSVs can be thought of as an improved version of raw scores. Both GSVs and raw scores
measure underlying ability; as ability increases, they both increase. However, the raw score
increases faster or slower depending on how many items there are at a particular region of
difficulty. If there are a lot of items, raw score increases quickly as ability increases, because
there are many items on which the person can demonstrate their improvement. In a region
with few items, raw score increases slowly. What this means is that a given increase in raw score
corresponds to different amounts of increase in ability depending on the level of the scale
where the change occurs.

GSVs attempt to remove this inconsistency. A GSV is an estimate of the ability level that would
most likely have produced an observed raw score. Thus, GSVs adjust for the effects of the
uneven distribution of item difficulties. By their nature, they attempt to be “equal interval”; that
is, a given change in GSV reflects the same amount of change in ability at all levels.

Of course, GSVs do not perfectly achieve this goal. The Rasch model on which they are based
is a simple one in which a person’s probability of success on a test item is based on just two
things, the item’s difficulty, and the person’s ability. Nevertheless, they are a fundamental
improvement over raw scores because they address the problem caused by the distribution of
item difficulties.

Additional GSV-related resources

Mark Daniel’s Blog:

An interview with Mark Daniel, author of Growth Scale Value (GSV):
Theory, Development, and Applications

Report:
Growth Scale Value (GSV): Theory, Development, and Applications

Blog with featured recording:

Are GSVs a more accurate measure of change?
 Exploring optimal
protocol outcomes?

Let’s start the process together!

We are grateful for the opportunity to partner with you in your clinical trial! Here is a
step-by-step look at your Pharma journey:

1. C
 ustomer inquiry: If you are new to Pearson, please complete the “Request a
Consultation Form”. If you already have an Account Manager, you can reach out
directly to discuss your study. An intake form is to be completed for each new study.

2. D
 iscovery call: Organizations should be prepared to discuss the entire scope of the
project including timeline, budget, assessments and related endpoints, administration
and scoring, languages needed, patient volume, rater training plans, etc.

3. C
 onfirmation of study details: Your Account Representative will facilitate
communication and planning for any new translation work, API integrations, and rater
training requests.

4. L
 icensing contract finalization: Once the details of the study have been
confirmed, your Account Manager will share the first draft of the licensing contract for
your review.

5. C
 ontract approval and invoicing: Your licensing contract will be finalized with
signatures from all parties. Payment terms and schedule are set up at this point.

6. P
 roject execution: Upon receipt of payment or purchase order, existing Pearson
intellectual property will be sent to you electronically.

7. R
 eceipt of all project deliverables: Pearson Translation Support will ensure
access to, and receipt of, all documented project deliverables as outlined within the
statement of work.

Take the first step on your Pharma journey!

800-627-7271 | PearsonAssessments.com/Pharma

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