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.
As you transition your product from development to commercialization, meeting our common goal is in sight: making effective treatments available to patients, quicker.
Parexel provides integrated support services and insights to reach this goal, ensuring alignment with regulatory agencies, payers, prescribers, and health technology assessment (HTA) agencies. We sharpen your product’s market access strategy with a holistic approach to elevating clinical trial performance, offering in-depth insight to optimize your portfolio strategy.
When you bring the right data to regulatory and reimbursement stakeholders to demonstrate value, you can better align with them to bring novel therapies to patients and address unmet needs. Starting early is the key. Getting insights from HTAs, payers, and clinicians helps us model different scenarios, with evidence generation targeted to the differentiated value attributes of the product and predefined success factors. We integrate a deep understanding of the prescriber’s perspective on unmet needs and clinical outcomes. Finally, we look at product value through the eyes of patients – not as data points, but as people who will decide to use your product as part of their treatment journey.
Navigating the needs of multiple global commercial stakeholders, with varying systems and processes to determine value and access is complex. In a rapidly evolving industry, key market dynamics demand attention:
By engaging with stakeholders early in the development process, we can collectively gather crucial data that satisfies both regulators and payers, ultimately ensuring timely access to medicines for patients.
With the complete suite of services to optimize market access, maximize price and market share and drive success on a global scale, our services include:
We advise on RWE strategies (including registry studies), alongside your clinical development program, to reassure payers that your clinical results are reflective of what will be evidenced in real-world clinical practice.
Our RWE experts work with you to explore the impact of a therapy and/or disease in a real-world setting, generating data that will support your value proposition to regulators, payers, physicians, and patients. We understand the need for interconnected, patient-specific, longitudinal data to track outcomes over time and partner with companies of all sizes to solve this challenge, including use of hybrid prospective/retrospective RWE studies. Our solutions include:
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.
Provide valuable insights into the causal association between a treatment (e.g., a drug, device, or procedure) and a particular event or outcome (e.g., long-term effectiveness and safety).
We provide multiple options for late-stage programs, including pragmatic trials or interventional trials with experience in peri/post-approval research to back it up.
Many on our team have tenure with regulatory agencies, payers, sponsors, HTA decision-making bodies, and industry-leading organizations such as IFPA and EFPI – as well as advanced academic degrees in science, economics, health policy, and business. As a result, you benefit from academic rigor, as well as a real-world point of view relevant to reimbursement when developing and adapting your product’s evidentiary value story through the research lifecycle. We offer: