Learn the five requirements for designing effective, local, observational research that can support global product strategies.
Real World Data Services
A simplified solution to generate real-world insights
The need for real world evidence is clear. Unfortunately, the pathway for companies to obtain the right data, data that presents actionable insights, is often unclear. The quality of existing real world data in healthcare can be poor and incomplete, since it is typically not collected for research purposes. A patient’s healthcare data is distributed across a diverse array of systems, which often results in gaps and can present significant challenges to connecting all the available data for a patient.
To add to the challenge, there are many privacy regulations to navigate. Understanding exactly what data are needed by stakeholders, when certain types of data can be utilized and the significant regulatory uncertainty around use of real world data, are only adding to the daily pressures.
PAREXEL provides a tailored approach to each real world evidence engagement – a customized strategy that is designed to help our client get fit-for-purpose data and the insights that they need - not just terabytes of data.
The three core components include:
- We bring together a multidisciplinary team of experts from technical, scientific, clinical and commercial disciplines including specialists inclinical research, medical affairs, HEOR, pricing and reimbursement, epidemiology, biomedical informatics, statistics and regulatory affairs. By bringing together a cross-functional team we are better placed to help our clients bridge the functional needs of their own stakeholders, enabling us to build a more robust real world evidence strategy. A customized strategy that is built on deep understanding of current standard of care, the patient outcomes that are important to clinicians, payers and patients, and an understanding of the impact of emerging treatment or changes to the treatment guidelines for the specific patient population.
- PAREXEL have developed a robust framework that allows us to better determine the insights needed for the various stakeholders and the specific data requirements that underpins them. Our experts evaluate the market landscape to fully understand the dynamics of the current standard of care and patient profiling for the therapy. We work with our clients to understand the differentiation of a product and we look at the evidence that’s already available, either through clinical research, within the public domain or other healthcare data sources. We determine the evidence gaps and build a plan to fill those gaps to help drive insights to support decision-making and inform the value story. Since PAREXEL is often supporting the pivotal trials and late stage clinical development of our client’s product, we seek opportunities to earlier address the needs of commercial stakeholders in parallel with regulatory data requirements which offer greater efficiency to our clients. Additionally, we can leverage prospective research such as an observational study as a key tool in filling gaps that have been identified in the real world data. We were pioneers in hybridized data source models, leveraging real world data sources in clinical research – something that regulators have identified as a key evolution for industry
A seamless technology infrastructure is fundamental to our approach. As real world data frequently needs to combine data from multiple technology architectures including data from healthcare sources, patient reported outcomes, electronic data capture (EDC) or a mobile health technology, a highly specialized infrastructure is needed. At PAREXEL, our Analytics Solutions consider logistics, distribution costs, tracking system updates, handling replacement devices and compliance. We provide seamless access to more than 300 secondary data sources and provide access to technology that can data-mine with patient-level linkage capability, provide analytics, data visualizations and support the creation of data lakes for structured and unstructured data.
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Late Phase Interventional Trials
PAREXEL® Access supports clients with strategies and systems specifically developed for late phase interventional trials. Our experience spans many therapeutic areas and ranges from single-country studies to those carried across multiple national boundaries and continents.
Monitoring the safety of medicinal products is a key concern throughout the product's lifecycle. At the time of product launch, drugs will have been tested on, at most, only a few thousand patients. This very fact is a concern to the EMEA, the FDA, and other regulatory agencies...
Observational / Non-interventional Research
Observational research encompasses several study designs in which groups of patients are observed within routine clinical practices. In the biopharmaceutical and medical device industries, observational studies can provide valuable insights into the causal association between…
PAREXEL® understands that requirements regarding post-marketing safety monitoring are more stringent now than ever. Numerous incidents involving marketed pharmaceuticals and over-the-counter (OTC) medicines in recent years have brought the issues of safety monitoring…