Transforming study start-up for optimal results

Insight brief Transforming study start-up for optimal results A holistic, data-driven approach integrating technology, insights and proven processes to position clinical trials for ultimate success Up to 30% faster start-up in certain therapeutic areas Executive overview With up to 70 percent of all trials experiencing enrollment delays, 1 nearly half completing later than originally planned 2 and one-fifth of sites recruiting no patients, 3 it s clear that a new approach to study start-up is required. To reduce delays that negatively impact trial execution and future revenue, a more holistic, comprehensive method is emerging. Quintiles has created the Right Start approach a study start-up solution that incorporates protocol validation, feasibility and planning, site selection and contracting, regulatory/ethics submissions, document management, and patient recruitment as an integrated process. Our framework of tools, processes and expertise is reducing timelines and improving the chance of trial execution success. 50% higher patient recruitment rates with our Partner Sites

An integrated approach for enhanced study performance For the greatest chance of on-time completion, clinical studies should begin on schedule, stay within budget and enroll the appropriate patients. But reality often paints a different picture. Up to 70 percent of all trials experience enrollment delays, 1 nearly half complete later than originally planned 2 and one-fifth of sites never recruit a single subject. 3 Lengthened timelines and sub-optimal site performance not only put trial execution at risk, they also prevent new products from getting to market and impact future revenue. These realities, coupled with the ever-present pressures to control costs in the face of growing complexity, are forcing biopharmaceutical companies to reexamine how they execute study start-up. Rather than addressing each piece of the start-up puzzle individually, a more holistic approach promises more productive results incorporating feasibility, site selection and contracting, regulatory/ethics submissions and patient recruitment as an integrated process. By including data, analytics and expertise at every step of clinical development, it s possible to anticipate and mitigate obstacles before they occur. Chart the right route to trial execution success Quintiles Right Start focuses on three phases: right path (the critical early groundwork), right start (streamlined site initiation) and right patients (strategic recruitment). Combining our data-driven tools, technologies and processes with industry expertise and global and local relationships, this integrated solution delivers critical upfront insights that can lead to better, more informed decisions as the trial progresses. We re also changing the way we work with customers shifting to a more outcomes-based model that allows both parties to share the risks as well as the rewards. Available as a stand-alone solution or part of a full-service engagement, this integrated approach has already led to faster start-up timelines up to 30 percent in certain therapeutic areas. Quintiles Right Start Improving your probability of success Data-driven tools & processes Deep industry experience RIGHT PATH RIGHT START RIGHT PATIENTS Right route to trial execution success Strategic global relationships Optimal approach leveraging data, expertise & analytics Streamlined start-up processes incorporating global & local knowledge Smarter recruitment combining insights into patient populations with site support 2 www.quintiles.com

The right path building a strong foundation The early planning process can have a significant impact on the chances of future trial success. We use data-driven tools and analytics to validate the viability of a protocol and determine how to best to carry out the study, including country and site strategies as well as risk mitigation. Data reveals optimal countries and sites Choosing the countries in which your trial will take place is one early planning decision that can have greatest impact on downstream success. That s why the decision process should be based on up-to-date data analytics. It s helpful to start by determining the key success factors of countries for your trial. For instance, a fast start-up record, availability of qualified investigators and low competition with similar studies are all attributes that can optimize trial execution. Two critical questions to ask: Do the patients exist there? and Can you enroll those patients within your timeline? Data collection can be the most challenging aspect of the process. You often need multiple methods for each type of data, and not every data source is relevant for every study objective. To ensure a balanced approach, Quintiles collects and analyzes data in six primary categories. Country & medical experts Internal proprietary data People Tools Patient primary research Data-driven approach yields better insights Processes External public & commercial data Data Investigator primary research Sponsor data Our approach combines an extensive internal database with external research and expert insight to gain the clearest, most comprehensive picture of prospective locations. We then develop algorithms and rank countries in order of appropriateness. Site evaluation is another step where early investment and engagement can yield positive outcomes. The therapy s indication, the goals of the study and the number of patients required should be all taken into consideration when scrutinizing site candidates. It s also important to closely examine the site s experience, capabilities and staff. Quintiles Infosario Site Gateway, an information portal accessible to all of our sites, allows us to capture in-depth site information for efficient feasibility analysis. From this global database, we can quickly deliver a tiered list of site candidates ranked from optimal to good to adequate. Once we ve identified the right countries, site strategies and enrollment forecast, we can begin to execute the critical, pre-planned logistics to put the trial in motion. 3 www.quintiles.com

The right start streamlining start-up Site selection, investigator contracting and budgeting, regulatory and ethics submissions, document management and site initiation are all critical to getting a trial off to a good start. These functions often happen at the same time, with multiple interdependencies and opportunities for delays to occur. Aligning activities at this stage of study execution can minimize decision-making and have a positive influence on productivity. Investigator contracts can complicate study start-up if the proper processes, planning and proactivity are not in place. Quintiles uses a highly specialized set of tools and standardized templates based on deep global and local expertise. When expediting study start-up, reducing the risks of bribery and corruption is a critical part of investigator contracting. Quintiles has developed a fair market value policy using benchmark data so that the payments made to investigators are fair, reasonable and equitable. Standardization of processes, templates and forms is another way to reduce cycle times. Our core informed consent form template, which incorporates all country-specific legal requirements, can save significant time on the front end. Harmonized processes can save time, too: Quintiles has experienced up to 45 percent faster investigator contracting timelines when using our optimized procedures. The right patients proactive strategies for optimized enrollment Finding and enrolling eligible patients is one of the biggest challenges facing clinical developers. However, patient recruitment and retention is often seen as an afterthought a tactic added on after other start-up activities have finished. Perhaps that s why up to 70 percent of clinical trials in the United States miss their patient recruitment timelines, and 20 percent of sites don t recruit any patients at all. The best approach is to address patient engagement early on starting as early as the design phase. Strategic upfront planning in our right path stage helps us pinpoint where ideal patients are located and anticipate future risks to recruitment and retention.that initial country and site selection and planning are designed to set the strategy that will maximize the potential for patient enrollment. A multichannel approach is then employed to engage patients and ensure that we meet study goals. The power of data analytics: Quintiles Infosario To make the best decisions at the right time, you need real-time access to relevant data from every aspect of your trial. So how can you integrate disparate information into one easily accessible platform? Our proprietary Quintiles Infosario technology platform enables: Dashboard and data visualizations at multiple levels to help us quickly take action when potential risks are identified Easier collaboration and minimized administrative burden forms and profiles can be completed online in a secure environment Analytics capabilities to harmonize our clinical trial management data and to predict future expected performance Visibility into the trial so we can take timely, proactive steps to keep it on course Gaining the patient perspective Each disease and treatment carries its own set of challenges, so it s important to consider the patient experience. What conditions or circumstances could motivate certain patients to participate in your trial? The best practice is to engage patients before the protocol is final. Gleaning patient insights, you can make small changes in your trial that could have a significant influence on enrollment and retention numbers. Digital patient engagement. Online communication is a fast and convenient way to engage with the patients you re trying to reach. Quintiles proprietary online patient communities, including disease-specific Facebook communities, offer us easy access to a wide variety of patients. We can also target a wider group as needed through online patient groups. The information we gain is used to inform study design, protocols, messaging and retention programs. 4 www.quintiles.com

Pre-recruitment activities. Years in advance of a sponsor s clinical studies, we can identify a patient population to start building a relationship with them. In the pre-recruitment stage, we might ask patients to complete questionnaires, provide them with information about their conditions and invite them to participate in our community. When a study becomes available near them, we invite them to prescreen for trial eligibility. Prescreening has multiple benefits: Not only does it help shorten timelines by providing a pool of alreadyqualified candidates, it also provides a way to monitor patients with conditions that can change over time. Medical record data mining. Electronic health records contain a wealth of patient data that can be used for recruitment planning. Quintiles Infosario Site Targeting is an app that allows us to query EHRs in the United States. We can look at criteria such as age, gender, medication history, diagnosis history, lab values and office visit frequency to build a general profile of the patient using near real-time data. The data can be used to create a virtual patient cohort that would meet the inclusion/exclusion criteria for the trial in question, and allow us to identify the investigators who treat them. A multichannel approach to recruitment and retention Quintiles employs numerous strategies and tactics to locate and engage eligible patients at all stages of clinical development. Site recruitment tools Pre-identification website Site awareness and reference tools Physician referral and bridging materials A leading-edge engagement model While limited partnerships those offering more oversight and involvement still have their place, the industry is moving toward more outcomes-based, holistic engagement models that free up internal resources. Quintiles has experienced up to 45 percent faster contracting timelines when using our optimized procedures. And our global network of more than 300 high-performing Partner Sites enrolls on average 50 percent more patients per site per month than non-partner sites. Patient-facing materials Outreach and advertising support Patient retention Site training and motivation Digital patient engagement Study awareness Informed consent and assent tools Educational materials on disease and clinical trials Quintiles Trial Enrollment Accelerator platform Global advertising campaigns International call center Pharmacy outreach Patient education and engagement Compliance and reminders Lost-to-follow-up prevention Study portal Investigator training Clinical trial educators (CTEs) Pre-enrollment communities Study website and pre-screener Digital outreach and social media Mobile solutions Direct-to-patient retention Envision trial execution success Clinical studies have many different goals, but all drug developers have a similar wish list: efficiency, cost control and, ultimately, products that arrive on the market as quickly as possible. With our Right Start methodology, Quintiles can offer a proactive, holistic approach to make streamlined study startup and a faster path to market a reality. 5 www.quintiles.com

References 1. CenterWatch Survey of Investigative Sites in the U.S. (2009). 2. Gwinn, B. (2011, June). Metrics for Faster Clinical Trials. PharmaVOICE. 3. Enrollment Performance: Weighing the Facts. (2012, May). Applied Clinical Trials. 6 www.quintiles.com

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