Industry-leading Site and Patient Capabilities Start Studies with Confidence In the face of increased cost pressures, longer development timelines and complex regulatory requirements, clients need to activate sites, find and enroll the right patients and start studies faster. PPD understands the cost implications that startup delays can have on a trial and provides fully integrated site and patient capabilities to accelerate timelines and start studies with confidence. Utilizing a comprehensive sites and patients offering, PPD is able to deliver industry-leading cycle times to clients and create significant cost savings while meeting study goals. 18 days Fas t e r 15 percent decrease in startup cycle times Industry SIA Model* 25 percent reduction in mean and median site activation cycle times as compared to prior Site Intelligence and Activation (SIA) metrics Greater predictability using our feasibility strategy to achieve reduced timelines from final protocol to site activation *“SIA model” includes only studies with FP on Jan. 1, 2013 or later to align with full deployment of new SIA model. Industry benchmark from CMR for the period of 2010-2012. Activate, Enroll Sites Faster PPD is able to deliver studies on time with our proven trial optimization methodology. This four-part approach results in high-level site enrollment and performance and includes: Development consulting/early engagement Experts with deep therapeutic knowledge engage with clients before the study’s protocol is developed or advise on an existing protocol to limit amendments and reduce costs. Data-driven analysis Analytics and expert recommendations are used to to improve forecasting in order to optimize both the protocol and the trial and to mitigate risk before a study begins. Investigator feasibility and site selection Continuous feasibility and optimization Sites and investigators with experience conducting similar studies and who are proven to recruit patients according to set timelines are recommended. A feedback loop is used to determine what parts of the trial optimization strategy are successful and what changes are needed to create time and cost savings. Accurate Predictability to Meet Study Timelines By utilizing Preclarus®, PPD’s innovative data and analytics platform, project teams are able to provide accurate predictability for site activation and enrollment in order to meet study timelines. Three key Preclarus dashboards are used in the startup process: ++ Global site selection: chooses the most qualified sites based on experience, quality and therapeutic match. ++ Study startup: reports status of country/site selection including the number of sites identified, eliminated and in the queue to be activated. Reports from this dashboard can be sent directly to clients, eliminating the need for additional reporting. ++ Study management: shows an overall picture of study performance including enrollment projections, status of site activations and the status of database cleaning. Empowering Patients Patients are at the heart of clinical research and their experiences drive the services we offer our clients. Engaging and empowering clinical research participants and their caregivers improves retention in studies and research outcomes. PPD helps its clients deliver life-changing therapies by continuously expanding its services with a focus on bringing the trial closer to the patient, through methods including: ++ Piloting the use of wearable technologies to collect data in a more convenient way for patients ++ Collaborating with patient advocacy groups across different disease areas to understand patient needs ++ Partnering with leading organizations to bring the trial closer to the patient in areas such as eConsent and patient enrollment and retention ++ Coupling patient recruitment via Acurian’s database with sites via Radiant Research’s network ++ Pioneering a means to pair patients with treatments via the Melanoma International Collaboration for Adaptive Trials ++ Creating patient and concierge services for engagement in specialized areas Confidence Through Partnerships PPD’s well-established partnerships with targeted networks create a comprehensive approach to site recruitment through access to high-performing sites. Leveraging these partnerships allows for global strategic site collaborations that offer a single point of contact, proven site performance and streamlined contracting agreements. PPD’s team of site collaboration experts creates relationships with external networks and associations and targets high-performing investigators within large academic teams, co-operative groups and major centers of excellence. PPD also works closely with Radiant Research, the largest U.S.-based, wholly owned network of clinical trial sites. With 75 Phase I-IV sites nationwide and a database of more than 2.5 million research participants, Radiant has successfully conducted more than 14,000 multi-therapeutic trials. Radiant’s enrollment rate of 97 percent is significantly better than industry standard and ranks in the top five percent of clinical trial sites in the U.S. Rapid Patient Enrollment with Acurian Working with Acurian further strengthens PPD’s feasibility, patient recruitment and retention offerings and can be provided as a fully integrated service offering. Acurian uses proprietary and highly predictive software analytics to customize the most efficient and cost-effective approach to recruiting patients for clinical trials and retaining those patients through to trial completion. With experience across many therapeutic areas, Acurian consistently delivers a high rate of return. 1,000,000+ STUDY CANDIDATES REFERRED TO SITES 800+ Enrollment Projects 7,000 Sites Engaged 100+ Unique Indications 5M Pre-screened Candidates 70+ Countries Expedited Payments, Site Satisfaction PPD established a dedicated investigator payment team in order to expedite payments and increase site satisfaction. The unit has expanded to include 120 team members located in key global areas including the U.S., U.K., Germany, Bulgaria, Manila and Singapore. With in-country resources, team members are able to offer global awareness of complex regulatory requirements as well as innovative solutions to associated challenges. twitter.com/PPDCRO facebook.com/PPDCRO youtube.com/PPDCRO plus.google.com/+PPDCRO linkedin.com/company/ppd For more information, please contact us at +1 877 643 8773, +1 919 456 5600 or at ppdinfo@ppdi.com. www.ppdi.com © 2016 Pharmaceutical Product Development, LLC. All rights reserved.