Integrated clinical development

Harness the power of whole-study solutions

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.


Move your medicine forward with patient-focused research

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.

Read the transcript

(Teri Karcher): Study start up has become much more challenging in recent years. There's been an increase in protocol complexity. We have a lot more third party vendor data, and we're seeing at an industry level additional challenges at our investigative sites. And so there's a lot of different and more nuanced approaches that we need to take in order to meet these needs.

Protocol burden is an essential consideration for both our patients and our sites. So, what we do is we provide our expertise into the protocol development early on to make sure that they're not more burdensome than is necessary to meet the scientific needs of our studies.

(Stacy Hurt): We have our internal patient community which are employees at Parexel, who use their lived patient caregiver experience to inform our protocols, we have a patient advisory council of global diverse perspectives. We have relationships with patient advocacy groups all over the world. In addition, we just launched our protocol needs assessment, which shows that when you fulfill patient’s needs as people first, they’re going to be more satisfied with their patient experience in a clinical trial. So it’s really multifaceted approach that we use, utilizing a lot of diverse perspectives to give us a really holistic view of protocol burden and help us solution these for our sponsors.

(Stacy Hurt): A strong patient insights package is really critical to improving the protocol because you have to understand that population that you intend to treat at the very beginning and truly understand what their challenges are, what their needs are, their motivations for participating in a clinical trial, and if you can capture that right at the beginning, then that can inform you all the way from early phase through drug development through late phase all the way through the end of the trial where we commit to providing late patient summaries so patients actually understand the results of the clinical trial journey.

(Teri Karcher): And it's critical to select the right sites for a study in order to recruit the desired patient population. With the right study planning and critical path oversight of our delivery execution, we can benefit patients by bringing the trials to them more quickly. And then this ultimately helps bring the drugs to market more rapidly as well.

(Stacy Hurt): That’s how Parexel is different, because we actually keep the patient’s needs at the center and at the forefront of everything that we do.

Phase IIb-IV clinical trials

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.

Phase IIb-IV clinical trials

To keep patient needs at the center of your research, we incorporate decentralized trial (DCT) elements into 80% of our Phase II-III trials.

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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.
 

Real-world evidence

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

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Patient engagement strategy and enrollment solutions

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.

Patient engagement strategy and enrollment solutions

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.

Protocol-driven, customized site solution strategy

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. 

25,000+regulatory submissions each year

Our former FDA, EMA and NMPA regulators, supported by 1000+ colleagues in local regulatory teams help you manage global complexity in changing regulatory environments. 

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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.

Market access strategy and delivery

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.

Clinical development technology optimization

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 trial supply and 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. 

Clinical trial supply and logistics

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. 

Patient inclusion

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.

Medical communications

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

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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™.

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