For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
We advise on real-world evidence (RWE) strategies throughout the product lifecycle to inform clinical development, reduce risk, improve the patient experience, and fulfill requirements from regulators and payers.
RWE can answer key questions in clinical research and promote a better understanding of patient experiences and outcomes. A foundation built from RWE supports the delivery of therapies that more closely match patient needs.
Effectively meeting the needs of multiple stakeholders (regulators, payers, physicians, and patients) takes a diverse bench of expertise. At Parexel, you have access to the best in access consulting, regulatory affairs, clinical research, medical affairs, health economics and outcomes research (HEOR), pricing and reimbursement, epidemiology, biostatistics, we effectively meet the needs of multiple stakeholders (regulators, payers, physicians, and patients). We help you build a value story early in development by crafting a fit-for-purpose strategy designed to support your product position in the context of:
With our proprietary cloud-based infrastructure, we’re capable of linking large volumes of data and applying sophisticated analytics and data visualization to identify evidence gaps and patient experience insights. We can also migrate data to your technologies, ensuring valid, accurate, and strategically derived assets.
By examining the ways drugs work in large populations, we’re better able to understand disease conditions, patient experience and the impact of therapies in large populations. Our specialists in epidemiology and biostatistics help you choose the right methodology depending on your specific objectives, using a variety of tools for this purpose, including:
Models generated from health claims, EMRs and other RWE sources
Our cross-functional teams, established processes, and cloud-based technology platform generate fit-for-purpose real-world data that strategically supports scientific or commercial analysis.
Observational research offers broad ways to answer questions about product performance, long-term safety, and patient outcomes. Non-interventional studies can help you understand more about causal associations between treatments and outcomes, and about the disease conditions in general.
Our team of pharmacoepidemiologists and pharmacovigilance, regulatory, and research operations advisors can do the following:
We provide multiple options for late-stage programs, based on safety commitments, product strategy and additional data needs for regulators and payers, with experience in peri/post-approval research to back it up.
We offer strategic and scientific guidance on design, implementation, and dissemination of patient-centric data generation throughout the product development lifecycle, with end-to-end reporting. As experts in the strategic application of PRO data as proof of outcomes and value and to fill evidence gaps, we handle licensing, translations, normative data, and migration to electronic PRO (ePRO).