Connect with the experts who've shaped the landscape
Our team comprises former regulators and health technology assessment (HTA) professionals who have played a pivotal role in establishing the very standards you are striving to achieve. We navigate global regulatory submissions, lead compliance activities, devise market access strategies and plan product launches. To maximize the market reach of your assets, we support global regulatory submissions and provide ongoing support throughout the entire lifecycle.
Get tailored advice from a specialized team
Because products for different diseases will follow different paths to market, we offer deep expertise across many therapeutic and specialty areas, including oncology, rare diseases, cell and gene therapy, and others. Leveraging this specific knowledge, our consultants create tailored strategies for engaging patients, generating compelling evidence, developing value stories, and mitigating risk.
We’re a consulting group. Of course, we’re lockstep with our clinical colleagues, helping them with their clinical programs. But consulting means we get really close to our clients. We have to be in listening mode. We have to understand their problems before we can find solutions for them.
Compressing timelines, removing regulatory barriers, creating value, consulting to create the right price for our products, ensure reimbursement, a and ultimately to take and remove and lower as many barriers as we can to patient access, ultimately. We’re very excited about that.
A noticeable trend has been the biotech companies seeking to de-risk their portfolios, their assets earlier on, with the goal of going global with their own products and developing themselves going to launch. And the smaller companies, with their assets, need the arms and legs that Parexel can bring and the expertise. They're not going to invest in global capabilities necessarily for a product that is, that carries risk. So that's definitely a shift and one we're very aligned to. And hits our sweet spot. Of course, we have a lot of enterprise customers, 50% of our portfolio.
But taking a biotech company that has aspirations to go global and compressing their timelines, creating value, that's really exciting is something that we're, very aligned with. It requires some planning to engage in that kind of conversation. It requires the right expertise, credibility, and hand-in-hand with our clients, were increasingly able to facilitate that and drive and accelerate the drug development process through some of these barriers.
What I hear repeatedly, and I'm most heartened about is customers complimenting us as showing up as part of their team, integrating in their teams, not being arrogant and telling them how to develop a product, but rather go in in listening mode, understand their challenges, and then bring the right expertise to the table to help them to succeed.
Our solution experts
Paul Bridges, Ph.D.
President, Consulting
Chris Learn, Ph.D., P.M.P.
Senior Vice President, Head of the Cell and Gene Center of Excellence
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Stephen Pyke, DIC
Chief Clinical Data & Digital Officer
Matthew Gordon
Vice President, Real-World Evidence Strategy
Sanjay Vyas
President, Safety & Logistics and Country Head of India
Teri Karcher, Ph.D.
Executive Vice President, Head of Launch Excellence & Chief Drug Development Officer
Katie Connelly
Senior Vice President, Global Head of Regulatory Operations
Our solution experts
Paul Bridges, Ph.D.
President, Consulting
Chris Learn, Ph.D., P.M.P.
Senior Vice President, Head of the Cell and Gene Center of Excellence
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Stephen Pyke, DIC
Chief Clinical Data & Digital Officer
Matthew Gordon
Vice President, Real-World Evidence Strategy
Services
Real-world evidence
Explore the impact of a therapy or disease in a real-world setting, generating data that can support your value proposition without additional burden to the patient. Our real-world evidence (RWE) strategies help reassure payers, regulators, providers, and patients that your clinical results are reflective of what will be evidenced in real-world practice, helping demonstrate value before, during, and after launch.
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.
Global regulatory submissions and outsourcing
Navigate the dynamic landscape of regulatory requirements, including the ever-changing demands of dossier preparation, submissions, and lifecycle maintenance. Plan for the strategy and intelligence-gathering activities crucial to your success.
Let our global team of experienced regulatory professionals collaborate with your internal team, enabling them to remain agile, focused and dedicated to the strategic imperatives driving your innovation and corporate goals.
25,000+regulatory submissions each year
Our former FDA, EMA and NMPA regulators, supported by 1,300+ colleagues in local regulatory teams help you manage global complexity in changing regulatory environments.
Compliance and risk management
Building a culture of compliance while effectively managing risk is a delicate task that requires trusted expertise. Whether you’re in development or are manufacturing at commercial scale, we specialize in GxP compliance services.
The pandemic, and recovery from its impact pose unprecedented challenges to supply chain stability. Partner with Parexel to mitigate these risks, ensure regulatory compliance and secure the continuity of your supply chain.
100+GxP audits annually
Ensure uninterrupted supply, from development to manufacturing and market availability of vital products.
Market access strategy and delivery
The potential for new treatments to benefit patients becomes a reality in the later stages of clinical development. But success relies on satisfying the needs of key stakeholders. Neglecting the data required by regulatory agencies, payers, prescribers and health technology assessment (HTA) agencies can cause significant, and costly delays between approval and reimbursement.
We understand the intricacies of market access strategy and planning as you plan the pivotal trial. Work with our team to design the optimal path to meet the commercial requirements of your target markets.
600+global value dossiers in the last 10 years
We know how to build powerful global value dossiers that are elevated by clear, resonant value stories.
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.
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