Value Substantiation Lifecycle Management

Expand your value story with real-world evidence and regulatory expertise

To continually make a case for the merits of your product, turn to the power of real-world evidence (RWE), regulatory insights, and therapeutically aligned medical writing. We design and execute post-approval studies that bolster your value story, delivering data that satisfies payers and regulators while building trust with patients and their health care providers.


Amplify your product’s impact with lifecycle management

We support your post-launch product with holistic regulatory, compliance, market access, and communications consulting. We begin by generating real-world data to demonstrate value — but we also communicate that value to stakeholders, protect value through compliance, and weigh value against risk to assess marketing authorization renewals. Let our integrated team help your drug get the most out of its lifecycle.

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In the integrated drug development model, which I think of it as really a team sport, commercial, regulatory, health economics, market access, medical, clinical operations coming together.

And then for my team, the market access team, is really to think about how we demonstrate value. Is this new therapy, is this new drug something that's going to be paid for?

You need to think about, how is clinical practice going to change? What kind of evidence a payer is going to be looking for. And you can do that very early on by understanding what is the clinical value of your product. What is it that makes it different from every other product? What is it that clinicians that payers and patients are going to appreciate about your product? Now, those three things, those stakeholders are very different, and what they want from a product is very different. So we come in and we help you understand what those requirements are, but we also help you engage with those different stakeholders as well. Getting their opinion.

Also, you know, sort of pushing the boundaries and understanding what they think the future landscape would look like as well. I've got a colleague and he says, "Uncertainty is kryptonite to payers." So what we want to do is ensure that you're reducing the uncertainty. Now, we're not saying, you know, collect every outcome that's out there, but we can help you determine what are going to be those outcomes that payers are going to--that's going to resonate with payers.

What they're going to look at and say, "Yes, I now understand how this drug is going to benefit patients."

In the field of cell and gene therapy, which is fairly new, we probably have ten or fewer approvals in the world. The market access team has actually worked on several of those drugs that are now available to patients saving lives. And I'm thinking not just cell therapy here, but specifically CAR-Ts, drugs that are amazing scientific innovations and the work of our economists, the work of our market access people in concert with our clients, have helped to ensure that these drugs are reimbursed and made available to patients.

And I really think without that work, we might still be marveling at the clinical data, but not really being able to quantify the value, which is at last step that the sponsors need in concert with payers to make sure that patients are getting on drugs.

Real-world evidence and market access strategy

Regulators and payors look to unmet needs and product value as determinants for access. By focusing on these outcomes, value demonstration in the later stages of development is designed to clearly convey how the drug will benefit patients.

Our RWE and late phase access teams partner with you to demonstrate value pre, during, and post launch. Our insights ensure that the clinical data you’ve invested years in developing translates to optimal access, ROI, and most importantly improved patient outcomes. 

21%more likely drug launch with RWD

Our research with the Economist Intelligence revealed how real-world data (RWD) strategies like ours significantly improve the likelihood of a drug launching.

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Regulatory compliance, drug safety, and pharmacovigilance

The speed and finesse with which you handle a consent decree, compliance audit, data integrity issue, and authority relations and communications can mean everything to a successful launch. Our compliance team, unequaled in experience and perspective (with former regulators on staff), can get you to safe harbor with reduced down-time, preserved ROI, and authority trust intact.

Our solutions include risk evaluation and mitigation; compliance services; PSUR and DSUR services; integrity safety; GCP, GLP, and GMP consulting; data integrity services; health authority consulting and liaison; compliance audits; inspection training; and more.

80+former regulators and inspectors

Our compliance consulting group is equipped with the expertise to help you mitigate risk, manage remediations, and restore brand and regulatory confidence.

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Lifecycle optimization

With the rising cost of developing new treatments and mounting challenges in development overall, it’s Business 101 to explore the full spectrum of lifecycle management options that maximize the ROI of existing assets. Our expert regulatory and market access teams are ready to provide competitive assessments and positioning to keep your products relevant, as well as handle maintenance submissions, APRs, DMFs, DSURs, PSURs, RIMs, regulatory intelligence requirements, and more — getting it right the first time.

1,350+annual product reviews

We’re ready to evaluate your treatments with an annual product review (APR), to ensure your treatments continually reach their full potential.

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Medical communications

Engage the people who matter most. At Parexel, we combine a comprehensive portfolio of medical communications services with expertise in all major therapeutic areas, as well as clinical development, patient engagement, real-world evidence, health economics, market access, regulatory, and more — to communicate vital data to your stakeholders.
 
Our team consists of Medical Affairs strategists who collaborate with highly skilled PhD, PharmD, and MD writers, seasoned medical editors, meeting logistics experts, and creative, digital, and design specialists. Together, we enhance educational experiences and bring your science to life across every stage of development.

Medical communications

Our writers have deep experience across therapeutic areas, resulting in more relevant, impactful medical communications.

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Operational excellence

Constantly evolving how we deliver trials

The purpose of our Operational Excellence and Delivery Office is to continuously and consistently improve the way we run your trials. By assembling our most experienced, cross-functional team members, we create best practices business wide that accelerate timelines, generate compelling evidence, promote innovation — and empower us to deliver With Heart™.


Frost & Sullivan's 2023 North American Customer Value Leadership Award

Parexel Recognized with Frost & Sullivan's 2023 North American Customer Value Leadership Award for impactful real-world evidence solutions addressing customer needs.

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