Phase I Clinical Trials

Running your trials around the world

The first stages of a clinical trial are vital to success, and choosing the right partner is critical. Our phase I clinical trials are delivered through early phase focused global site network with embedded early phase clinical units.

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 a 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.