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 take an integrated approach to early-phase studies, helping you mitigate multifaceted risk. Through a unified strategy that addresses every aspect of development, we enable faster decision making and establish a sound foundation for later-stage work.
The smartest early-phase research capitalizes on both current and coming opportunities. Whether our team is guiding biomarker selection, planning for diverse patient recruitment, or steering regulatory strategy, we work with the future in mind. Because we understand the challenges you’ll face at every milestone, we help you make future-informed choices that smooth your product’s path to market.
Our solution experts
Oliver Fuhrmann, Ph.D.
EVP, Early Phase Development & Regional Head Europe for Clinical Research Innovations
EVP, India Country Head & Managing Director, Global SBU Head -Safety Services & Logistics
In Phase I, we test your drug in humans for the first time. Drawing equivalence between two different species, with different enzymes and biology, is technically challenging, but our translational science team takes the animal data you’ve acquired and precisely translates it into human data, resulting in a quick and reliable move to a first-in-human trial.
Human testing is heavily regulated across jurisdictions. Our experience and relationships with major regulatory bodies help determine where and when to start a first-in-human trial and generate the validating data you need. Our network of early-phase partner clinics and our experienced teams in clinical pharmacology and modeling and simulation support you in fast and reliable progress through Phase I.
Our translational science group provides the necessary foundation for success, moving the data derived from healthy humans into those in a disease state to confirm that the biochemical processes are the same. We focus on determining dosage requirements, working to generate data powerful enough to show investors that the drug successfully treats the disease state.
To support this goal, we offer support across all major therapeutic areas, give you access to a global investigator network, and provide ethnobridging capabilities to accelerate worldwide development.
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.
Both initial recruitment and retention are increasing problems for clinical trials, resulting in delays, early study closings, and less reliable results. It can be difficult for potential study participants and their physicians to learn about clinical trial opportunities. The complexities of trial start-up impose additional delays. All of this slows the progress of research.
We provide a network of sites and investigators, as well as connections with community and specialist physicians, so patients have a path to studies through their established care delivery systems. Our IRB partnerships speed up approval, and our established relationships with key opinion leaders enable sponsors to identify possible barriers before the start of protocol development.
Study start-up has become increasingly challenging. Protocols are more complex, the volume of necessary third-party data is larger, and investigative sites are more difficult to manage. Choosing the right sites and ensuring that protocols don’t impose unnecessary burdens on the recruited participant population facilitates a smoother experience for you and investigators.
Our clinical adjudication program identifies potential issues early in the process. Our drug safety and pharmacovigilance continually monitor risks and benefits to study participants, immediately identifying possible safety issues. And our health economic modeling brings economic endpoints into the study, ensuring that the eventual drug will demonstrate cost effectiveness.
Regulatory planning and risk mitigation at this early stage of development is a major contributing factor to successful drug development outcomes. Partner with our global team of ex-regulators and industry specialists in the early phases of product development for regulatory intelligence, strategic regulatory advice, agency consulting and engagement, regulatory gap analysis, product development plans, and more.
Build the complete evidence package that payers require, from the outset. At Parexel, we’re perfectly positioned with fully integrated regulatory, access, HEOR, RWE, and patient-reported outcomes (PRO) services to collect the right evidence. Starting early is key, and as a result, you benefit from a real-world point of view relevant to reimbursement while developing and adapting your product’s evidence-driven value story throughout the research lifecycle.
Bioanalysis and genomic research are critical to drug development and trial design. When you identify target biomarkers and genetic variants early in the development process, you’ll have a clearer idea of the steps you need to take to turn your new drug into a reality. You’ll be able to select patients for your study with greater accuracy and confidence, ask the right questions when designing your trial, and better articulate the benefits of your drug when it’s time to enter the market.
At Parexel, we offer a comprehensive portfolio of services to help you develop a winning biomarker and genomic medicine strategy.
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 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.
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.
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™.