Real World Evidence in Clinical Trials

Real world evidence

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.

Real world evidence in clinical trials can answer key questions 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.

Multidisciplinary approach

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:

• Market landscape
• Current standard of care
• Unmet patient needs

Robust technology

• The real-world data we access is generated from multiple sources including:
• Healthcare insurance claims data
• Hospital data networks
• Electronic medical record (EMR) data
• Drug prescription and pharmacy data
• Clinical outcome assessments (including patient-reported outcomes)
• Disease registries
• Lab biomarkers data

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.

Support for research in large populations

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:

• Prospective disease registries
• Comparative observational studies

Models generated from health claims, EMRs and other RWE sources

Our solutions

Real world data (RWD) services

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/non-interventional studies

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:

• Help you define the needs of your target audiences and develop the best study design to meet your objectives
• Define the optimal regulatory authority and ethics committee submission strategies in each country or region
• Implement a study management and resourcing model trained to collect required data efficiently and according to agreed-upon quality standards

Late-stage clinical trials

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.

Patient-reported outcomes (PROs)

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).

Our RWE team

• 20+ years of experience in the design, implementation, and analysis of RWE studies across the globe
• A multidisciplinary approach to building RWE strategies that meets the needs of patients, payers, regulators, and other key stakeholders
• Data search, storage, integration, and analytics capabilities, supported by an extensive and proprietary technology platform and approach
• Depth of experience in assessing evidence gaps and in evidence-generation planning
• Broad expertise in strategic, operational, clinical development, regulatory and market access consulting, and successfully conducting RWE studies of all types