It can be a long and complex journey, taking your scientific innovations out to the world. This is only the first reason why PAREXEL is the perfect partner to help you get there. As one of the world’s largest and most experienced biopharmaceutical service providers, we have the global infrastructure, harmonized protocols, and advanced technologies to uncomplicate the process for you, accelerate your time to market and contain your development costs while minimizing risks of late phase failure. It all begins with our end-to-end approach to conducting clinical trials. From feasibility analysis, site selection and patient recruitment to clinical monitoring, data collection and management on through NDA preparation, submission, and post-approval studies, PAREXEL is committed to your entire journey.
Whatever the size or scope of your study, PAREXEL provides the comprehensive clinical research services you need, from First-in-Human through Phase IV and Post-marketing follow-through. We also have the regulatory expertise, clinical trial operations management, payer and market access planning, medical education and communications capabilities to see your journey through efficiently and effectively.
Explore every phase for a complete picture here (Phases of clinical trials)
The first steps of any journey include choosing the smartest route to your destination.
Going from new molecular entity to drug treatment opportunity is more than a goal, it’s a journey. It’s a complex trek that starts with evidence-based valuations to predict a drug’s efficacy, regulatory acceptance, market potential, licensing impact and more. When you carefully map out the route that lies ahead of you, and have the decision-support technologies to clear obstacles, prospects for success increase greatly. PAREXEL brings together the best minds, processes, and technologies to take you through every phase of development more successfully, including getting you off to a strong start.
To make the journey from new molecules to new medications easier, start with a partner who will be beside you at every step.
Today, simplifying your drug development journey takes a smart partner, one with clinical expertise, integrated technologies, and its own early phase hospital-based units already in place on three continents. With a nimble and proven ally saving you time and expense during and between clinical processes, your compounds enter First-in-Human studies faster, which also helps you accelerate your timeline. PAREXEL® has the global SOPs to perform Phase I trials in harmony across multiple locations, and stands committed to the success of your journey.
By accelerating your access to the right patients and expertise, we accelerate your access to efficacy data.
Your journey advances more smoothly when you can show regulators and financial stakeholders early on that your new molecule is effective. That’s why PAREXEL® has developed an integrated and adaptive approach that supports Phase IIa outcomes. From early phase trials that can take you into Proof-of-Concept studies through to product launch, we can activate the appropriate patient populations, biostatistical expertise, and ePro technologies you need, when and where you need them. PAREXEL provides the right resources in the right places, customized to provide the data you need to expedite your objectives.
We’re already planning where to guide you next to make your journey to Phase II-III success faster and easier.
After initial proof-of-concept, your progress to Phases IIb and III will have global twists and turns. That’s when PAREXEL®’s worldwide infrastructure and end-to-end expertise mean the most. Our experienced consultants have the advanced resources, smart strategies and clinical logistics to implement pivotal trials faster, while our eClinical technologies, trial management, and regulatory knowledge minimize costs, risk, and delays. PAREXEL already has the patient populations, the therapeutic expertise, and regulatory access in place to elevate your journey to the next level.
As you approach regulatory submission, having a technologically advanced partner to steer you through is crucial.
Your journey is moving from drug development to commercialization, and you need a team with long-standing expertise in both. You need an integrated late phase team of development and commercialization specialists with global and local market insight, a team with a proven track record of advancing new drugs through late phase clinical trials, compassionate use studies and real world studies, rigorously compiling data to satisfy multiple stakeholders – regulatory agencies, physicians and payers, to name a few. PAREXEL® has provided world class peri/post-approval services for over a decade. This is why we know this part of your journey so well. We helped plan it.
After all the science, trials, and paperwork, how long and far your new drug will go depends on its use in the real world.
For your new drug to reach its intended market after launch, it takes ongoing data management and multi-pronged marketing. Safety data from larger populations expand trust and show regulatory compliance, while tactical marketing to key players builds recognition as it accelerates product acceptance, formulary adoption and recommendation by health professionals. PAREXEL®’s world class post-launch team integrates scientific strategists, medical writers, clinicians, former regulatory officials, creative teams, and social media experts to continue the journey into long-term market viability.