Post-Marketing Research

At PRA, we understand what post-marketing research is – and just as importantly – what it is not. Our insight is what sets us apart. The insight of our team of specialized, post-marketing experts that ensures the right design and approach for your study. The insight to achieve operational efficiencies through our simple, flexible, and customized approach. The insight to utilize our global teams to harness practical knowledge of local regulations, standards of care, and cultural customs. The insight to leverage industry-transforming, data-driven approaches and predictive analytics to provide you with access to the best target site and patient populations. The insight to employ unparalleled data assets to maximize efficiency and reduce burden to sites. And lastly, the wisdom to connect these varied insights to make a difference – for you, our clients, and for the patients who inspire us to do what we do.

We are a partner centre of the ENCePP scientific network, which is coordinated by the European Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We register studies in the ENCePP E-Register of Studies, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

Our real-world approach to science, operations, and analytics help you optimize your Post-Marketing Investment.

Maria Harrison – Vice President of Late Phase Services

01
Late Phase Services

We recognize the importance of global coverage, along with the reality that global studies are executed locally. PRA’s multi-lingual, post-marketing country experts, who are strategically located in Asia, Germany and the Americas, have the necessary tools, knowledge and resources to successfully manage both small and large studies. In addition, PRA leverages an industry-leading, non-interventional study regulatory database to gain access to vital study start-up data and activation timelines on current country-level, observational research as well as regulatory requirements for 60+ countries. PRA’s multidisciplinary team of therapeutic, scientific, safety and operational experts in real-world research can help guide the strategy and execution of high-quality late-phase programs that result in safer and more accessible drugs. While scientific rigor is the foundation for our late-stage designs, we leverage data-driven approaches and predictive analytics to transform late-phase research and provide our clients with access to the target site and patient populations. We combine this approach with a centralized site management model that optimizes our clients’ ROI and service fee reductions. Solutions_Post_Marketing_Global_SCC_SMA_Graphic_JUNE2014

02
Study Design

Solutions_PostMarketing_LatePhaseServices_Graphic With more drugs on the market than ever before, the need to demonstrate real-world evidence of product effectiveness, safety and value has increased. PRA develops comprehensive study designs that fully demonstrate our many years of post-marketing experience. Our in-house, cross-functional teams, which consist of highly trained scientific affairs and therapeutic experts, statisticians, data managers, centrally based monitors and other clinical operations personnel, will proactively manage your study and define specific risks. Our team’s ongoing relationship with the site eases the burden of study participation and ensures one path of communication for all the project needs. This relationship also helps to foster the development of strong site relationships and facilitate investigator/site personnel involvement and study commitment. Fully trained and certified in a diverse offering of industry-leading EDC and paper-based systems, we support a broad range of study designs, providing flexibility to sponsors who already have selected an enterprise solution. From site management tools to guidance on EDC software, we advise you on the most effective and efficient ways to capture data while keeping your prescribers in mind. PRA thoroughly audits and validates our in-house and third-party systems ensuring they meet all regulatory requirements. We deliver multiple methods of data collection, such as flexible EDC and electronic patient reported outcomes eCOA (ePRO/eClinRO/eObsRO), along with hybrid models to allow for paper collection. Sponsors have access to the latest study metrics and reports through our efficient, state-of-the-art Web portal systems.

03
Proven Experience

Post-marketing research at PRA combines our therapeutic and scientific experts as well as our safety and risk management professionals to provide you with a wealth of non-interventional and post-approval experience. Working together, they identify research goals for real-world data collection, interpret regulatory commitments and create protocols to meet your needs. We stand out among CROs based on our team of global therapeutic experts that leverage medical data to understand the standard of care in a variety of indications. Such data allows for comprehensive observational protocol development, site identification, data analysis and publishing results. To evaluate global prescribers and patient populations for late-phase projects and studies, our scientific experts analyze public and private databases and apply a proprietary methodology to best identify the most appropriate sites and patients for real-world research. Utilizing global medical informatics data, we target the optimal geographic areas for disease prevalence and identify physicians who best fit the needs of the study. Our global network of post-approval safety and risk management professionals are well-versed in global, post-marketing regulatory authority requirements and have the ability to conduct safety and risk management services throughout the product’s life cycle. Risk-based monitoring (RBM), specific to post-marketing research, requires a multi-disciplinary team that delivers real-world strategies that utilize triggers, scores and assessments to determine study risks at both the site and patient levels. PRA’s flexible, cost-effective methods are fully aligned with the FDA Clinical Trials Transformation Initiative and the EMA’s recommendations. PRA’s late-phase team members have been developing and employing RBM strategies since the early 1990s, driven by the growth of large-scale post-marketing and Phase IIIB research.

04
Observational Research

PRA has implemented a unique observational research model that consists of 3 key elements: science/strategy, project management, and site management/central monitoring. Led by global, non-interventional experts, our model operates with the flexibility and infrastructure of dynamic organization fully focused on meeting our clients’ program needs. Our experts have extensive knowledge in how to properly design and execute observational studies – and collaborate with specialists throughout PRA in other functional areas such as data management, statistics, pharmacoviligance, and onsite monitoring. Moreover, we design studies to minimize burden on the sites while optimizing participation.

We further maximize the results of our observational studies with advanced tools, such as our Non-Interventional Country InformationTM (NICITM) system. It provides current observational research regulatory requirements for 60 countries to help reduce activation timelines. We use an array of state-of-the-art analytical tools to conduct data review and trend identification, evaluating each site’s training needs, and supporting the collection of timely and high-quality data.

05
Safety & Risk Management

Minimization of risk to patients has always been a top line priority in the context of new medicinal product development. Regulatory authorities now, more than ever, emphasize the importance of appropriate safety management infrastructure. The development of risk minimization strategies suitable for the whole life cycle of the medicinal product is imperative. PRA is committed to the importance of safety and providing solution-oriented Safety & Risk Management services through our global drug safety centers in Europe, Asia and the Americas. Safety & Risk Management