Phase I Clinical Trials

Move to first-in-human studies confidently in all major regions of the world

In early phase development, time really is money. The sooner you can make a go/no-go decision, the sooner you can allocate resources to optimize the development of your portfolio.

Parexel has a well-earned reputation for helping clients move quickly in early development, without shortcuts. The key is our comprehensive capabilities and flexibility to meet your needs: An early phase global site network with four embedded early phase clinical units capable of running virtually type of early phase study, from first-in-human to proof-of-concept, across a range of participants from healthy volunteers, niche populations and patients.

We also bring the expertise and operational capabilities for hybrid studies – which combine sequential studies (SAD/MAD/DDI) into a single protocol - safely bringing patients into research much sooner than traditional designs allow and reaching the critical milestone of proof-of-concept earlier.

The power of early proof of concept goes beyond reducing times. Sponsors can take findings to regulators for discussions about expedited pathways. Early clinical evidence helps biotech innovators increase their chance of securing investment in an ever-competitive funding environment.

Running your trials around the world

The first stages of a clinical trial are vital to success, and choosing the right partner is critical. The choice of Phase I study location can significantly impact development speed. Whether you develop your molecule in the jurisdiction of the FDA, EMA, MHRA, or other regulatory body, our regulatory experts are ready to address the unique challenges of each. We also offer trials in China, Japan and Australia, where we have established agency relationships and a strong understanding of local requirements. Across our global network of alliance sites, Australia is an increasingly preferred destination, owing to favorable regulatory timelines, well-developed research infrastructure and tax incentives.

To further support your development, our clinical pharmacology, modeling, and simulation solutions combine clinical pharmacology modeling and simulation with clinical PK/PD and pharmacometrics for a more strategic approach to clinical development. We’re also industry leaders in ethnobridging, with 15 years of experience.

Access patients faster 

We’ve built relationships with some of the most well-recognized sites that also offer early phase expertise. This global early phase network provides access to key patient populations in the therapeutic areas of interest that are propelling the most innovative areas of pharmaceutical-led care. Parexel has also invested in our own hospital-based units and embedded them into this global network of alliance sites for a more versatile approach to support early phase studies. 

Parexel's four hospital-based clinical units are strategically based in three regulatory environments around the world: US (Baltimore, Los Angeles), UK (London), and Germany (Berlin). These units offer in-house scientific and medical expertise, combined with the latest in clinical and research technology. As full-service locations, we have a wide range of healthy volunteer and patient enrollment capabilities for your clinical development needs, supported by biostatistics, data management, medical writing and programming teams who exclusively focus on early phase studies.

Proof of concept: Phase Ib-IIa

The primary objective at this stage is determining dosage requirements. So much in clinical development depends on getting the dose right. Our clinical pharmacology, modeling and simulation team can guide dose selection and optimization through quantitative approaches that generate enormous benefits downstream. These approaches help sponsors deliver the greatest benefit to the patients with the fewest unwanted side effects, thus minimizing the patient burden and reducing the time to bring promising treatments to market  
Our proof-of-concept studies give you support for new clinical development across all therapeutic areas. This range of knowledge makes us flexible enough to complement your capabilities with biostatistical know-how and eClinical technologies. We also have interactive voice and web response systems ready to assist with everything from randomization and drug inventory to electronic data capture.