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.
Katie Connelly:
A company must really focus on a couple of key areas to make sure that they continue to see success of their approved product. The first and foremost is they need to maintain compliance. They have to ensure that a product remains in a state of compliance, delivering against the routine regulatory and pharmacovigilance post-marketing requirements, and any post-marketing commitments that they have made.
They also need to develop a comprehensive strategy for the entire lifecycle of that product. And what they need to be considering is what new formulations may they be bringing in down the line? Are there different combination therapies that they may be focusing on to get more access? They also need to look at how any changes in regulations may be coming that would impact that overall strategy.
Value demonstration. This is where we encourage clients to be thinking about how they demonstrate the value of their product early on in the clinical development lifecycle process. When you get to the post-approval stage, you need to ensure that your product is reimbursed and is able to be accessed by patients. And this helps to ensure that the company is going to see the ROI that they intended to see and improve the overall patient outcomes with patients being able to access that product.
From a future planning perspective, companies should also ask themselves what's next? How do they look to leverage the real-world data to support further expansion of their label or look to new indications? By having patients use this product in an everyday usage, that real-world data is invaluable to help them look to how they can expand and drive further ROI for the development of their products.
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.
Our solution experts
Sangeeta Budhia
Senior Vice President, Pricing & Market Access
Jackie Vanderpuye-Orgle, Ph.D.
Senior Vice President, and Global Head of Advanced Analytics, RWE & HEOR
Mike D’Ambrosio
Senior Vice President and Global Head, Real World Research
Sanjay Vyas
President, Safety & Logistics and Country Head of India
Katie Connelly
Senior Vice President, Global Head of Regulatory Affairs
Our solution experts
Sangeeta Budhia
Senior Vice President, Pricing & Market Access
Jackie Vanderpuye-Orgle, Ph.D.
Senior Vice President, and Global Head of Advanced Analytics, RWE & HEOR
Mike D’Ambrosio
Senior Vice President and Global Head, Real World Research
Sanjay Vyas
President, Safety & Logistics and Country Head of India
Katie Connelly
Senior Vice President, Global Head of Regulatory Affairs
Services
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.
Regulatory compliance
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.
1,300+regulatory specialists, including former regulators from agencies across the world
Our compliance consulting group is equipped with the expertise to help you mitigate risk, manage remediations, and restore brand and regulatory confidence.
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.
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.
Our writers have deep experience across therapeutic areas, resulting in more relevant, impactful medical communications.
Integrated evidence generation planning
Parexel offers expertise in developing and delivering IEGP for various organizations, from big pharma to small biotech. Our services include early-stage strategy development, tactical planning, function-specific support, and advisory services.
By partnering with us for integrated evidence planning, you can maximize your assets' potential, streamline development processes, and improve commercial outcomes in a competitive market.
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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