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PPD brings a full state of readiness to deploy global clinical programs. During COVID-19, PPD quickly implemented an active pandemic committee and business continuity planning and recovery committees. We are providing clients an innovative suite of digital and virtual solutions and are helping transfer clinical trial patients into our dedicated research sites. Learn more on why PPD is the partner of choice.

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CASE STUDY

HELPING DELIVER LIFE-CHANGING THERAPIES

PPD Quickly Deploys Direct-to-patient (DTP) Strategy and Hybrid Trial Model for Patients to Safely Continue Receiving Care

BACKGROUND AND CHALLENGEAn ongoing anemia study with thousands of patients enrolled at hundreds of sites around the world was at risk of delays due to the COVID-19 pandemic. With a complex protocol that included cold chain comparator and controlled ambient investigational medicinal product (IMP), there was a need to rapidly adapt and provide a solution so dosing patients could continue and that travel to clinical sites would not be a requirement during this time. Knowing the clock was ticking, the global biopharma company reached out to PPD for an immediate strategy to protect patient safety and study continuity while preventing additional risk to patients.

ADAPTING PROTOCOL FOR MAXIMUM FLEXIBILITYPPD’s medical monitor and clinical team discussed the client’s original study need for a third-party lab to collect and process hemoglobin tests. Our teams helped to review, adapt and optimize study requirements by removing this testing step and reconstructing the protocol to allow for a more rapid response to patient need.

DTP IMPLEMENTATIONEarly in the pandemic, PPD proactively established a global process with our preferred partner to enable DTP services for all PPD-managed studies.

Equipped with a proven process, our experts were able to quickly provide the client an implementation plan that included a recommended volume of DTP shipments of IMP (requiring temperature control of 2°C to 8°C and 15°C to 25°C). Per the study protocol, these DTP shipments had a tight turnaround time of three to five days for collection with same-day or next-day delivery, depending on location.

A project-specific shipping process was set up for the study with forecasts of need provided to the vendor. Simultaneously, the forecast was provided to our preferred DTP partner to allow for preparation of the relevant materials in country. Our global clinical supplies and project delivery team members continued to closely monitor shipments and volume against projections, developing reporting and informing future forecasts.

TELEMEDICINE OPTIONS IN LIEU OF PHYSICAL SITE VISITSWith the expertise and guidance of PPD’s digital and decentralized solutions group, in-clinic visits were conducted with patients via telemedicine provisions from their respective, local investigator sites.

SOLUTION

PPD leverages key digital and operational capabilities to rescue and decentralize a study in a matter of days

BACKGROUND AND CHALLENGEA dermatology study was successfully underway in Italy that required several primary end points to be collected via in-person clinic visits. Following the impact of COVID-19, stringent controls were implemented by the Italian government to restrict the movement of people that directly resulted in the risk of five patients being unable to attend a planned visits – and therefore, the inability to collect primary end point data from these visits.

1. A TeleVisit lite module

A visual communication tool used to facilitate investigator and patient interaction, developed specifically in response to COVID-19.

2. Consent to support the application of the TeleVisit

Ensures compliance for the TeleVisit to proceed.

CASE STUDY

www.ppdi.comHELPING DELIVER LIFE-CHANGING THERAPIES

SOLUTION Strategy

Technology

The Italian Ministry of Health (MOH) released guidance that supported rapid adaptation of the approved study protocol and the subsequent amendment process, facilitating the continuation of the patient visits. Our digital trial team was continuously monitoring the situation and via their consultancy group were to implement a technology solution that would allow the primary end points to be collected as planned. Over the next week, our digital and operational experts collaborated to develop a successful strategy for the customer.

PPD’s digital trial group implemented a TeleVisit solution, powered by Medable, that enabled our teams to quickly deploy to the site. This included:

AN INNOVATIVE APPROACH TO DELIVERING A GLOBAL SITE AND PATIENT SOLUTION

STRATEGIC FEASIBILITYAccelerating study startup is critical to reducing the time and cost of drug development. The stakes are highest for patients—those participating in clinical trials and those awaiting new therapies they generate. With this in mind, PPD offers an industry-altering site and patient solution—a new approach that puts the patient at the center of startup. We have fine-tuned startup objectives, expanded resources and realigned our expertise and operations to create this startup model.

Our site and patient solution incorporates the patient perspective into clinical innovation, study feasibility and protocol design, site selection and activation to optimize patient participation and follow-on research efficiencies.

GLOBAL SITE INTELLIGENCE & ACTIVATIONS

CLINICAL INNOVATION

ACCELERATED ENROLLMENT SOLUTIONS

SITE NETWORKS & PATIENT CENTRICITY

FLEXIBLE, COST-EFFECTIVE OPTIONS TO SUPPORT YOUR EVOLVING NEEDSThrough FSP partnerships, PPD provides professionals who serve as an extension of your team, providing much-needed key support service. No matter the size of the company or phase of the drug, we provide flexible, predictable and cost-effective options.

Whether you need support for specific tasks or therapeutic areas, or meeting the demands of pipeline peaks and troughs, PPD FSP can provide a flexible, cost-effective solution with control and transparency. We can help reduce the need to hire and train specialized staff or provide 24-hour workforce coverage when needed.

Our shared pool of resources gets you highly trained talent through the full force of PPD's global infrastructure.

Top-Tier Experts,Not Backup

We expand access to talent, protect budgets and set you up for success through a secure capacity management tool.

Streamline Capacity Managementand Planning Oversight

Our 25 years of FSP experience and strong retention rates ensure quality and dedication to your study.

Quality and Long-Term Dedication

We can align to your needs through a pay-for-performance, risk/reward or a hybrid model.

Pricing Structured to MeetYour Outsourcing Desires

PPD IS SOME 24,000 PEOPLE STRONG GLOBALLY WITH 4,000+ PEOPLE SUPPORTING FSP CONTRACTS

A FULL SPECTRUM OF CRO SERVICESWe have supported the FSP model for over 25 years, covering all functions and services, from clinical to marketed products. Whether filling small gaps or supplementing large-scale programs that

require dedicated capacity management across all functions, you get highly trained talent backed by the full force of PPD’s global infrastructure through our shared pool of resources.

PPD FSP - PEOPLE WHO DELIVER To learn more, visit ppdi.com/fsp

Discover how PPD’s digital and operational experts collaborated to develop a successful strategy

for collecting patient data

PPD FSP can provide a flexible, cost-effective solution to support specific tasks or therapeutic areas

and to meet the demands of pipeline peaks and troughs

PPD offers an industry-altering site and patient solution – a new approach that puts the patient

at the center of startup

PPD can help you develop a strategy to protect patient safety

and study continuity while preventing additional risk to

patients

Leading Global Contract Research Organization Committed to Delivering Life-changing Therapies

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