For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
We design and deliver studies that ensure patient safety, data integrity, regulatory compliance, and scientific rigor. Our integrated strategies address these priorities and more, allowing us to reduce burdens, mitigate risk, and operate efficiently within timelines and budgets.
Data shows that patient-informed protocols increase a drug’s likelihood of launching. That’s one of the reasons we design trials that accommodate patients’ needs and preferences. And by removing barriers to participation, we accelerate study enrollment, boost adherence, and construct stronger value stories.
Our solution experts
Today, as the design and conduct of clinical trials continue to evolve, decision-making needs to be informed by strong expertise in biostatistics, data analysis, and data management. This knowledge is essential to ensure patient safety, data integrity, and operational feasibility as flexible protocols become the norm.
At Parexel, we offer this depth of expertise in supporting protocol design, trial execution, site management, and all the way through to market strategy and commercialization. We take a risk-focused approach, continually assessing the tangible risk of the trial so we can control it, adapt to it, and keep everything running smoothly.
To keep patient needs at the center of your research, we incorporate decentralized trial (DCT) elements into 80% of our Phase II-III trials.
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.
Many clinical trial participants face barriers to participation, from inadequate information about study opportunities to inconvenient times and locations for test visits. As a result, some patient populations have lacked access to possible therapies, and studies have lacked the diversity of participants required to ensure widespread effectiveness.
We focus on the practicalities of patient access and engagement. We recruit widely and track proper population diversity throughout the study. By capturing patient preferences and maintaining appropriate communication with them, we help you recruit and retain the diversity of participants you need.
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.
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 Community Alliance Network gives you access to more sites, diverse populations, and investigators so you can be confident in your site selection strategy.
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.
Our former FDA, EMA and NMPA regulators, supported by 1000+ colleagues in local regulatory teams help you manage global complexity in changing regulatory environments.
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.
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.
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.
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.
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™.
Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials
Jul 28, 2022
Addressing the Challenges of Artificial Intelligence used for Data Extraction in Systematic Literature Reviews
Mar 15, 2023
Ensure End to End and Vein to Vein Success for your Clinical Trial Supply Chain
Oct 14, 2022