Integrated clinical development

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.
 

To access the patients your study needs, we incorporate decentralized trial (DCT) elements into our proposals.

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Model-informed drug development

Quantitative clinical pharmacology, pharmacometrics, and programming combine to create a strategic approach in clinical development, optimizing the match between patients, treatments, and dosages.

This integrated approach leverages pharmacokinetic and pharmacodynamic data to guide trial design and drug selection, ultimately reducing development time and costs while maximizing patient benefits and minimizing side effects.

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Over the course of 90+ dermatology studies that enrolled 30,000+ patients our patient education and engagement tactics led to better screening rates, optimization, and a lower dropout rate.

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Protocol-driven, customized site solution strategy

In response to the increasing complexity of trial protocols and the pressures faced by sites, we accelerate study start-up by helping you find the right sites, patients, and partnerships. Our multidisciplinary Launch Excellence Office aims to meet the specific needs of your study, offering study planning, critical-path oversight, and delivery execution as key elements. We also engage in partnerships with groups offering a broad range of perspectives, so we can design protocol and site-selection strategies with the biggest possible impact in mind.

Our Site Alliance Network gives you access to more sites, diverse populations, and investigators so you can be confident in your site selection strategy.

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Regulatory strategy, submissions, compliance, and outsourcing

At this pivotal point in the development process, take control of your regulatory pathway and reduce compliance risks to simplify and accelerate your treatment’s journey to patients. 
Our global team of former regulators helped set the standards you’re striving to meet. We’ll help you optimize your regulatory pathway to maximize the value of your product. 

Market access strategy and delivery

Even with a flawlessly executed clinical trial and a strong regulatory strategy, there’s no guarantee of a successful product launch. Without robust commercialization planning, patient access and return on investment (ROI) may be limited.

We’ll help with that, by delivering a product market access strategy that merges clinical and development plans with regulatory and health economic strategies.

Our market access team has the experience and expertise to help you optimize ROI and patient access, having completed 150+ market access strategy projects in the past 10 years.

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Clinical development technology optimization

To make the most of your valuable data, we design fit-for-purpose technology solutions — suites that capitalize on our own mature systems along with best-in-class technology from industry-leading vendors. Each solution is engineered and implemented by experts to address the specific needs of your trial and team.

Our solutions go beyond data collection. We learn about the decisions your team will face, then create ways to curate, visualize, and monitor your data so that you can make those decisions quickly and with confidence.

We won the 2022 Frost & Sullivan Global Customer Value Leadership Award for excellence in planning, operationalizing, and delivering decentralized trials (DCT) worldwide via leading-edge technology.

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Clinical logistics

Whether conducting a small regional or a complex global trial, you need a robust supply chain network that includes country-specific knowledge and a close connection to local authorities. We provide the knowledge, systems, and connections to achieve end-to-end clinical trial supply chain management. We’ll help you build a supply chain that sails through international pressure points and delivers drugs to patients and trial sites right on schedule.

To ensure that our clients are free to conduct trials around the world, we operate a hub-and-spoke network of depots that seamlessly move drugs and ancillary supplies to investigator sites. Our skilled team of trade compliance professionals will handle customs declarations, apply for permits, and manage interactions with local governments so you can focus on running the best trial for your patients. 

We’ve won multiple Asia-Pacific Bioprocessing Excellence Awards, including 2021 Best Clinical Supply Chain, 2020 Best Supply Chain Digitization, and 2019 Most Robust CRO Supply Chain.

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Patient inclusion

Clinical trials have often been an exclusive space, rather than an inclusive one, with serious consequences for patients in underrepresented groups. At Parexel, it’s our mission to change that. We’ve gone straight to patients, caregivers, physicians, and community leaders to identify factors that prevent patients from enrolling in clinical trials.

No matter what steps you’ve taken to address equity and inclusion in your trial design process, we’re ready to work with you. We’ll help you design trials that include patients who otherwise might not have been able to participate due to issues such as time, finances, and transportation. By focusing on inclusion, you’ll help more patients while developing drugs and therapies that can work for all. 

Through TriNetX Live, we’re able to access a network of millions of patients in more than 30 countries, so you can access the diverse populations you need.

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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.

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

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Drug safety & pharmacovigilance

In the rapidly evolving landscape of innovation-driven medicine, ensuring drug safety has become increasingly complex. With vast amounts of data from diverse sources, managing safety information is more challenging than ever. At Parexel, we leverage nearly 40 years of expertise to navigate these complexities, providing comprehensive pharmacovigilance services that prioritize patient safety throughout a product's lifecycle. Our integrated approach combines cutting-edge technology and AI-powered solutions to deliver actionable insights and streamline processes. 

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.

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