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.
Our solution experts
Sangeeta Budhia
Vice President, Pricing & Market Access
Jackie Vanderpuye-Orgle, Ph.D.
Vice President, Advanced Analytics
Rito Bergemann, M.D., Ph.D.
Vice President, Health Economics & Outcomes Research
Susan Kammerman
Senior Vice President & Worldwide Head of MedCom
Sanjay Vyas
President, Safety & Logistics and Country Head of India
Matthew Gordon
Vice President, Real-World Evidence Strategy
Our solution experts
Sangeeta Budhia
Vice President, Pricing & Market Access
Jackie Vanderpuye-Orgle, Ph.D.
Vice President, Advanced Analytics
Rito Bergemann, M.D., Ph.D.
Vice President, Health Economics & Outcomes Research
Susan Kammerman
Senior Vice President & Worldwide Head of MedCom
Sanjay Vyas
President, Safety & Logistics and Country Head of India
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, 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.
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.
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.
Related insights
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Webinar
Navigating the complexities of AML drug development
Oct 30, 2024
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Webinar
Leveraging post-marketing regulatory requirements to drive commercial value
Oct 16, 2024
Blog
Single-arm trials as pivotal evidence: Key considerations and implications for drug developers
Oct 11, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development
Sep 20, 2024
Blog
Transforming evidence generation: How predictive AI can optimize clinical development
Sep 3, 2024
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Jul 31, 2024
Blog
New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US
Jul 16, 2024
Blog
Exploring China’s new pilot regulatory program for rare disease drug development
Jul 10, 2024
Blog
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Jul 1, 2024
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Blog
Real-world evidence methods for regulatory decision making: An HMA/EMA update
Jun 21, 2024
Blog
Pursuing alternative approaches to animal models in drug development: EMA innovation task force and scientific advice opportunities
Jun 6, 2024
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Blog
The clock is ticking on EU-CTR transitions: To meet the deadline, act now
May 20, 2024
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Blog
Accelerating Delivery and Patient Access to Rare Disease Treatments – Highlights from World Orphan Drug Congress
May 2, 2024
Webinar
Final countdown: How to transition your trials under EU-CTR
May 1, 2024
Related insights
Webinar
Challenges and best practices for developing Antibody-Drug Conjugates (ADCs)
Nov 12, 2024
Webinar
Navigating the complexities of AML drug development
Oct 30, 2024
Blog
FDA’s final guidance on renal impairment: Assessment of the regulatory approach to inform clinical development planning
Oct 23, 2024
Webinar
Leveraging post-marketing regulatory requirements to drive commercial value
Oct 16, 2024
Blog
Single-arm trials as pivotal evidence: Key considerations and implications for drug developers
Oct 11, 2024
Blog
PD-1 inhibitors face scrutiny in esophageal cancer: Key takeaways for drug developers
Oct 4, 2024
Blog
FDA releases draft guidance on oncology multiregional clinical trials (MRCTs): Key considerations for global drug development
Sep 20, 2024
Blog
Transforming evidence generation: How predictive AI can optimize clinical development
Sep 3, 2024
Blog
Gene therapy: are high costs and manufacturing complexities impeding progress?
Jul 31, 2024
Blog
New FDA draft guidance: Implications for simplifying interchangeability for biosimilars in the US
Jul 16, 2024
Blog
Exploring China’s new pilot regulatory program for rare disease drug development
Jul 10, 2024
Blog
Key implications for nonclinical development: FDA guidance on human gene therapy products incorporating human genome editing
Jul 1, 2024
Webinar
Advancing mRNA-based drug development and vaccine manufacturing
Jul 1, 2024
Blog
Real-world evidence methods for regulatory decision making: An HMA/EMA update
Jun 21, 2024
Blog
Pursuing alternative approaches to animal models in drug development: EMA innovation task force and scientific advice opportunities
Jun 6, 2024
Blog
Making cell and gene therapy more accessible in the treatment of solid tumors
Jun 4, 2024
Blog
The clock is ticking on EU-CTR transitions: To meet the deadline, act now
May 20, 2024
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Blog
Accelerating Delivery and Patient Access to Rare Disease Treatments – Highlights from World Orphan Drug Congress
May 2, 2024
Webinar
Final countdown: How to transition your trials under EU-CTR
May 1, 2024