Early Phase Clinical Trials

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Global execution. Early phase expertise.

Success in early clinical development depends on making the right decisions early. Parexel supports Phase I and selected Phase Ib/IIa studies through a globally connected early phase network, combining dedicated clinical units, scientific leadership, and regulatory expertise to help sponsors move from first-in-human through early patient studies with confidence.

Our early phase capabilities span healthy volunteer and patient studies, supported by experienced teams in clinical pharmacology, scientific services, data design, and operational delivery. We work across major regulatory environments including the US, Europe, and the UK, and also support studies in Asia-Pacific through established local expertise and regulatory partnerships in markets such as China, Japan, and Australia.


Dedicated early phase infrastructure, built for speed and quality

The Parexel early phase network features four wholly-owned clinical units strategically located across three regulatory environments: the US (Baltimore, Los Angeles), UK (London), and Germany (Berlin). This positions sponsors to benefit from efficient enrollment, experienced site teams, 24/7 participant oversight, and state-of-the-art technology.

Our capabilities extend through a complemented network of partner sites—including APAC expertise—enabling comprehensive guidance at the project, program, and asset levels. We also provide patient recruitment, biostatistics, data management, medical writing, programming, and medical oversight, all delivered by teams with deep experience in early clinical development.

Designed to deliver at scale for complex clinical studies, our in-unit pharmacies and processing laboratories support comprehensive clinical compounding and high-volume PK/PD sampling with full chain-of-custody documentation. We excel across the full spectrum of early phase designs—from first-in-human and SAD/MAD studies to food effect, DDI, QTc, and patient pharmacology studies. This positions us to provide right-fit, agile solutions that accelerate decision-making and speed promising therapies to market.

Step inside our clinical units with an immersive 360-degree video!
 

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Scientific insight to guide early development decisions

Early phase development is not only about execution. It is about generating the right evidence to inform next decisions. Parexel integrates clinical pharmacology, modeling and simulation, and strategic development expertise to support dose selection, study design, and program optimization across the early development pathway.

We bring particular strength in areas such as ethnobridging and quantitative clinical pharmacology, helping sponsors design smarter studies, interpret data faster, and reduce uncertainty as programs advance.


CONNECTED GLOBAL NETWORK

Earlier data. Faster enrollment. Quicker decisions.

Success in clinical development depends on making the right decisions early. Parexel’s global early phase ecosystem brings together scientific depth, regulatory insight, and operational excellence to help sponsors accelerate timelines, improve decision‑making, and advance promising therapies efficiently. 
 

From first-in-human to early patient studies

As early phase studies become more complex, sponsors need a partner who can bridge operational execution with scientific and regulatory insight. Parexel supports the transition from healthy volunteer studies into patient-based early development, including Phase Ib and selected IIa programs where early proof of pharmacology or proof of concept is required.

With integrated technology, experienced teams, and a focused early phase network, we help sponsors accelerate timelines, improve decision-making, and advance promising therapies more efficiently.