Drug development is an extremely time-intensive and costly process. Pinpointing the ideal sites and prepping them to enroll patients can be an incredible challenge. With that in mind, PPD has developed a novel approach to accessing sites and patients — a new approach, grounded in clinical innovation, that puts the focus on patients. By fine-tuning startup objectives, expanding resources and realigning our expertise and operations, we've created an industry-leading, integrated startup approach. This helps PPD to focus completely on helping our clients meet aggressive enrollment goals and bend the cost and time curve of drug development.
We're able to do this through the power of innovation and big data — harnessing information and deploying data-driven methodologies that empower us to use the right sites to reach the right patients. Through this, we can increase enrollment, enhance site productivity, reduce the number of non-enrolling sites and engage with patients in new ways.
Strategic, Data-driven Feasibility
With skyrocketing development costs and expanding study timelines, determining the viability of a study is more crucial than ever. Traditional approaches of feasibility relied on site surveys and other unreliable methodology. Now PPD has shifted that ineffective paradigm, exploiting analytics and external data sources to develop models that guide our innovative, strategic feasibility services. We’re able to provide additional reliable information more quickly to guide site selection and recruitment planning, support protocol and trial optimization, and centralize country and site selection.
We merge data from patient, investigator and site perspectives to drive our recommendations. We use multiple data sources, including:
- PPD investigator, laboratory and clinical trial data
- De-identified patient data
- Competitive historical trial data
- Proprietary site network data
- Proprietary lab data
- Electronic medical and health records (EMR/HER) and claims platforms
Based on strategic feasibility assessment, PPD:
- Confirms whether identified patients exist at preselected sites
- Recruits patients based on compliant, re-identified patient records
- Predicts site activation and patient recruitment rates for sites, countries and studies
- Challenges and optimizes protocol design parameters to increase the potential pool of patients
- Simulates and estimates treatment costs/utility for specific patient populations using real-world evidence
Accelerated Enrollment Solutions
PPD’s focus on access to sites and patients is strengthened by our accelerated enrollment solutions business unit that delivers leading patient enrollment services, patient engagement and retention services and access to site networks.
Through accelerated enrollment solutions, we offer innovative services aimed at inverting the traditional site selection model, focusing on maximizing patient delivery from highly accelerated and predictive centralized recruitment. Unique models are tailored to specific study needs to provide patient-focused services that save time and costs, while delivering control and certainty, including:
- The PatientAdvantage model that combines our services to recruit all the patients our clients need using fewer sites and less time. This model delivers predictable outcomes through a fixed price model where all CRO services, site services and patient recruitment are provided in a single price-per-patient.
- Oncology enrollment enhancement solution uses a just-in-time methodology to jumpstart study enrollment, augmenting traditional enrollment approaches to activate sites within 14 days of patient identification.
Additionally, our clients benefit from the industry-leading services of Acurian, so that we deliver a comprehensive suite of services designed to deliver enrollment certainty and study completion. These global services are patient-centered and process-driven to maximize patient enrollment and retention. In addition to a variety of complementary services, Acurian offers patient enrollment, patient engagement and retention, and strategic enrollment consulting services.
Strategic Site Collaborations
Recognizing that identifying the right sites and preparing them to enroll patients is one of the biggest challenges faced by our industry, PPD continuously expands our site network relationships. These relationships are a key component in accelerating quality research and the foundation to fully support patient enrollment and engagement. Our therapeutically aligned and constantly expanding strategic partnerships with global site networks, facilitate easy study setup and execution. These networks include:
- PPD's global Phase I site network of 30+ sites in the U.S., EMEA and Asia-Pacific
- Our PPD® Select network that includes PPD's top-performing sites based on recruitment and quality
- PPD's early phase oncology network (EPON) of 30+ global oncology sites
- PPD's pediatric investigator network (PIN) with key opinion leaders (KOL) and access to a large pediatric patient population
Global Site Intelligence and Activation
Delays of any kind can have a negative impact on development, but few things are as critical as site activation when it comes to trial timelines and site relationships. Recognizing that, PPD works to improve cycle times by harmonizing and planning startup activities across global study sites. Our best-in-class approach employs the sophisticated analytics of Preclarus®, our real-time data and analytics solution, to give operational teams cross-functional visibility to activate sites on time. Preclarus delivers analytics to manage site selection and study startup activities.
We're able to streamline operational processes to optimize cycle times using a technology-enabled approach to site selection and activation. Enrollment rates further strengthen our approach. Our global site intelligence and activation services allow you to:
- Streamline site selection process with historical reference sets/analysis to inform future opportunities and strategies
- Develop a statistically driven risk-prediction and escalation model that will accurately and reliably predict site activation and patient enrollment rates
- Provide transparency and accountability of forecasts, as well as a mechanism to course correct when deviating from targets
Patient Centricity and Innovation
Because we believe patients are the heart of clinical research, we strive to bring their views into the study design process earlier. Engaging and empowering clinical research participants, study sites and their caregivers improve retention in studies and research outcomes. Technology provides an avenue for making trials more convenient for sites and patients, as well as more efficient our clients. But we’ve also integrated patient-centric capabilities to bring the trial closer to the patient, such as:
- Historical patient data analysis and direct feedback from patients
- Engagement with influential patient advocacy groups
- Optimized patient communication and connection, including e-consent, reminder apps and social media messaging
- Meaningful involvement of the patient voice in protocol design
- Home trial support conducted by in-country national teams experienced in home care
- Transparent study results and feedback loop for patients
Through ongoing partnerships and innovative pilots, PPD is developing new clinical trial models that encourage study participation and reduce research burdens on patients and sites. Based on the goals of each study, we explore and advance designs aimed at delivering products to market faster and more efficiently, with a focus on expanding decentralized trial capabilities and use of mobile platforms, including:
- Creating patient reimbursement strategies based on targeted patient populations
- Providing patient concierge services to facilitate logistics and travel associated with trial participation
- Distributing patient education materials and offering follow-up services
- Providing site concierges to streamline site communication and increase site satisfaction