PAREXEL® INFORMATICS

PAREXEL’S PATIENT TECHNOLOGY SOLUTIONS

ELIMINATE RISK

• Industry-proven technology with a demonstrated patient safety record

• Industry-leading scientific expertise for optimized trial design

• Predictable performance

INCREASE QUALITY

• Improved patient retention and protocol adherence

• Single authoritative source of truth

• PAREXEL “Quality First” commitment

IMPROVE PATIENT LIVES

• Speed to market for therapies— 22% faster than industry standard

• Award-winning site and patient-focused innovations

• Global supplies and logistics to bring treatment to those in need

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PAREXEL has long been in the forefront of the use of technology in helping biopharmaceutical companies achieve their mission: to improve the human condition by developing life-saving treatments. Intrinsic to that mission is the ability to continually drive down costs and improve efficiencies, and digital transformation represents an essential foundation for achieving these goals.

As the Life Sciences industry continues the drive towards real-world evidence, studies will increasingly incorporate data reported by patients, sites and clinicians. Multiple data streams generated by, for example, questionnaires, diaries, images and wearable device outputs must be consolidated and validated to derive evidentiary insight of treatment effect.

PAREXEL offers a comprehensive suite of patient technology solutions that leverage our deep scientific expertise and technology innovations to help optimize patient, clinical and regulatory processes. In short, these solutions, available from a single source with unparalleled global proficiency, employ data to deliver insights, drive digital transformation, and focus on patient- and site-centricity.

Our solutions mitigate risk and ensure patient safety with proven technology supported by the best minds in the industry. By providing a single authoritative source of truth backed by PAREXEL’s “Quality First” promise, we focus on finding the right sites and participants for your studies, ultimately bringing your products to market faster to benefit the patients who are counting on them.

IN TODAY’S HEALTHCARE PARADIGM, IT IS NOT ENOUGH TO SHOW THAT A DRUG WORKS. IN FACT, MANY TREATMENTS DO NOT “CURE.” INSTEAD, THE ONUS IS ON THE BIOPHARMACEUTICAL COMPANY TO DEMONSTRATE THAT A GIVEN DRUG IS BETTER THAN THE STANDARD OF CARE, AND THAT IMPROVEMENTS REALIZED ARE CLINICALLY MEANINGFUL TO PATIENTS.

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• Project management – one central point of contact for many services and all modalities, with integrated project plans on a global basis

• Standardization and governance across multiple study teams, expediting timelines, reducing escalations and saving costs

• Unified site qualification process and comprehensive site training

• 24x7 help desk and subject support

• End-to-end data standards, with sponsor-specific data reconciliations

• Global supply and logistics, site-ready for first patient first visit with no delays, and provision of device logistics

• Single customer care solution

PAREXEL SUPPORTS THESE INITIATIVES WITHIN AN OVERALL FRAMEWORK THAT PROVIDES:

• One contact, many services • Integrated Project Plans • Global operational expertise • Ability to Deliver – We control all timelines, for no surprises

Project Management

• Across multiple study teams • Reduced escalations • Single Contract & expedited contract timeline • Cost Savings

Standardization/ Governance

Single Site Qualification Process

• Data validity and proactive clinical data monitoring • Patient /site ease of use • Communication of treatment value

• Instruction selection • Validation studies

Global Supply & Logistics

• Single contact for all modalities

Customer Care Services

• Sponsor-specific Data Reconciliation

End-to-End Data Standards

Scientific Expertise

• Site ready for FPFV – no delays • Provision of device logistics

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PATIENT SENSOR SOLUTION

We are at an inflection point in the biopharmaceutical industry. Study design has shifted away from traditional on-site visits to remote patient-centric studies. Wearables data capture minimizes clinical assessments and reduces the burden on patients and sites, for both patient convenience and sponsor cost efficiencies.

PAREXEL’s Patient Sensor offering uses PAREXEL’s broad services and clinical trial expertise to facilitate the collection of study-subject data via medical devices, coupled with robust predictive analytics. Our streamlined end-to-end offering creates efficiencies for sponsors and eliminates the need to contract separately with third parties.

During a study, the subject takes readings using the sensing devices from an allocated kit. PAREXEL’s Patient Sensor Solution, built to support the volumes of data collected by modern sensors, securely captures, transmits and visualizes the medical device data. The collection of subject sensor data is coordinated by PAREXEL’s Patient Technology Solutions group. These services encompass:

• Device selection advice and validation services

• Device integration within PAREXEL’s Patient Sensor Solution

• Sourcing, testing and distribution of sensors

• Development of easy-to-read instructions for study subjects and sites

• Analysis and delivery of wearables data sets

• Regulatory compliance with 21 CFR Part 11 and Annex 11, along with validation documentation available for audit

• Study-subject privacy and data encryption, with end-to-end connectivity meeting FDA and HIPAA standards

We design efficiencies into a single clinical record, integrating sensors into PAREXEL’s Imaging, Clinical Outcome Assessment (COA), Electronic Data Capture (EDC), and Randomization and Trial Supply Management (RTSM) solutions to offer a 360° patient view.

CLINICAL OUTCOME ASSESSMENT

Clinical outcome assessment describes a methodology for reporting by a patient, observer, caregiver or clinician by means of validated questionnaires, tools, diaries, surveys and device outputs. Advances in technology are facilitating the collection of better-quality, objective data, as smartphones are paired with devices such as spirometers, glucometers and blood pressure meters.

TECHNOLOGY SOLUTIONS

• Overall project implementation and risk management

• Instrument licensing coordination and timeline handling

• Single help desk unified with other services

• Shipping and logistics to ensure that devices arrive in time for first patient first visit

• Protocol review and optimization

• Therapeutic area expertise

• Good research practices

• Development and modification and instruments/ diaries/surveys

• Psychometric and linguistic validation

• Gap analyses

• Equivalence testing

• Nature of patient population

• Length, complexity and number of questionnaires; validation; and ease of use

• Frequency and location for data collection

• Primary secondary or exploratory endpoints

• Development guidelines

• Regulatory guidance

• Life-cycle evidence strategy

• Therapeutic factors

• HTA/reimbursement evidence needs

• Market access environment

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PAREXEL supports implementation by working with stakeholders to determine selection, modification, design, validation and mapping of a COA. These services continue through the entire product life cycle with an essential evidence component, from pre-clinical through Phase III studies, launch and post-launch. PAREXEL has extensive experience in this area, having supported more than 350 studies involving COA, conducted by more than 70 sponsors in 60 countries.

As of today, COA has evolved from an art to a science with development of standards and best-practice requirements. This evolution is being driven by the fact that patient insights are increasingly being sought from advocacy groups, social media and web listening. Furthermore, regulators and payers increasingly accept the value of COA endpoints in decision making.

PAREXEL’s COA services optimize completeness, accuracy and timeliness of data to support study objectives and evidence generation, helping to minimize the burden of data collection.

PAREXEL takes a comprehensive, integrated approach to COA, covering strategic and scientific considerations, data-collection modality and implementation. To help you develop a COA strategy, PAREXEL works closely with stakeholders to examine the following:

Study delivery considerationsScientific considerations

Data-collection considerationsStrategic considerations

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A PARTNER YOU CAN TRUST

Over a span of more than 30 years, PAREXEL has established a reputation as one of the world’s leading contract research organizations innovators of biopharmaceutical services, supporting our clients with cutting-edge technology solutions and a team that provides extensive medical and clinical expertise. PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceu-tical and medical device companies. Visit our website to learn how partnering with PAREXEL will help you achieve your ambitions. www.PAREXEL.com

MEDICAL IMAGING

Clinical study sponsors increasingly rely on advanced medical imaging technologies to serve as surrogate endpoints for studies of product efficacy and safety. PAREXEL® Informatics has therapeutic and medical imaging experts provide a range of capabilities in the application of the latest techniques to support every stage of clinical development. Our experience using novel modalities to accelerate early decisions about therapeutic agents is particularly valuable in today’s pressure-filled development environment.

Whether you pursue the highly prized Breakthrough Therapy designation or other pathways, medical imaging serves as a surrogate endpoint, revealing the effect of a drug much earlier than traditional endpoints.

Working with an imaging core lab that has more than 80 approvals and nearly 3 million timepoints process, our medical imaging services ensure that you will have proven processes and systems operationalized at every step, from site on-boarding to daily flow of images and queries. Our rigorous reviews for data integrity flag image problems early and ensure precise independent image-reading and analysis.

ELECTRONIC DATA CAPTURE

Managing today’s clinical trials is a complex and chal-lenging task, involving many different people, processes and systems. Study teams need to respond to rapidly changing situations and make timely, informed decisions throughout. Our DataLabs® EDC solution has a proven track record of helping organizations optimize valuable resources, gain efficiencies and ensure quality data.

Delivered through the cloud, PAREXEL’s DataLabs® EDC solution enables integration with clinical trial software to help users plan, design and conduct clinical trial programs in a single place. Advanced features help streamline the entire process, starting from study design all the way to collection, management and reporting of clinical trial data. Our DataLabs® EDC solution offers:

• Electronic data capture and paper data management in one powerful system

• Support for data-driven decisions through targeted Source Data Verification (SDV) to focus site-monitoring priorities, reducing on-site monitoring activities and associated costs

• Single intuitive user interface that enables rapid study build and ease of use in collecting study data

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We are always available for a conversation.

NORTH AMERICA Ricardo Edwards +1 978 313 1575 Ricardo.Edwards@PAREXEL.com

EUROPE & ASIA David Rolfe +44 1 895 61 4808 david.rolfe@PAREXEL.com

• Improved patient safety and data quality

• Study design comparison that eliminates manual comparisons and reduces validation time required to review design changes

• Robust safety monitoring, providing real-time notification of critical safety events that are time-sensitive for processing

RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SERVICES (RTSM)

At PAREXEL, we know that technology alone does not make for an efficient, high-quality approach to RTSM. Tailored RTSM consultation is included as standard for every study to enable the selection and implementation of the appropriate methodologies for each study. Our study design and delivery team works closely with key stakeholders to meet study-specific requirements and timelines.

The randomization methodologies and algorithms designed by our statistic experts have been used in more than 4,000 clinical trials, helping pharmaceutical sponsors achieve treatment-group balance, eliminate selection bias and limit the predictability of treatment allocations.

Our supply chain experts and technology help manage supplies easily and efficiently by automating the restocking of sites and depots across the supply chain. They can apply advanced methods to solve difficult supply issues that include managing adaptive trial designs, titration regimens or medication pooling across multiple protocols. Our ClinPhone® RTSM solution services offer:

• Expert project management, study design and delivery team

• Dedicated randomization, statistics and supply chain experts

• Global 24x7x365 support team

• Study design changes made quickly without going offline

• Tailored services for Phase I, II and III, peri-/post-approval and Asia-Pacific studies

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

© 2018 PAREXEL International Corporation. All rights reserved.

CORPORATE HEADQUARTERS

195 West Street Waltham, MA 02451 USA +1 781 487 9900

Offices across Europe, Asia and the Americas

www.PAREXEL.com