Phase I/IIa and Early Clinical Trials

Make earlier and more informed product viability decisions

We design and deliver studies ranging from standard through complex to help you answer important questions about your drug’s safety and effectiveness. With accurate data and precise insights, you can make a more informed go/no go decision and meet the needs of your stakeholders.


Connecting insights and superior delivery for better outcomes.

Leverage our expertise and operational excellence to get to a better proof-of-concept during early clinical development.

The attention of a niche CRO. The resources of a global leader.

Quintiles recognized as Phase I services leader for third consecutive year. Learn more.

Transforming respiratory development
Through our Integrated Early Clinical Development Platform, we can provide you with the personalized focus and attention of a small CRO with the resources of a global service provider to deliver a personalized solution for your Phase I study.

  • We are a dedicated Phase I team of doctors, nurses, CRA and other clinical staff with dedicated sites in Overland Park, KS and London, UK .
  • With the resources and expertise of a global leader with >33,000 employees operating in >100 countries, including ~950 Medical Doctors, >1,000 PhDs, and 14 Therapeutic Centres of Excellence

Accurate data which meets regulatory scrutiny

Our diverse operational experience and expertise in early clinical development has been honed over the past 30 years, spanning healthy volunteer, proof of concept, bioequivalence, PK/PD, food effect, first-in-human, and first-in-patient studies.

Delivering data to meet the needs of these complex studies requires a culture of continuous process improvement. Our Train-Plan-Prepare process helps ensure consistent processes and on-time dosing for your studies, while Failure Effects Mode and Analysis (FMEA) ensures a robust quality process is in place.

Leading with science

Our staff have recently published in leading journals such as New England Journal of Medicine, the Lancet, and the British Journal of Clinical Pharmacology. We can help develop your biomarker strategy from the start with capabilities spanning genomics, respiratory, ECG, immunology, cell biology, imaging, clinical pharmacology as well as PK/PD modeling and simulation.

  • Identify and apply exploratory PD biomarkers, and help enrich study populations with the use biomarkers for inclusion/exclusion criteria
  • SAD/MAD combination studies and studies with an additional cohorts, and adaptive design

Learn about our Phase I Units

Ready to transform your drug development?

  • First-in-Human, First-in-Patient, and Healthy Volunteer Studies
  • Clinical Pharmacology
  • SAD/MAD combination studies
  • Drug-Drug Interaction Studies
  • Ethnic Bridging Studies
  • Food Effect Studies
  • Special Population/PK/PD Modeling and Simulation Support
  • AME/Mass Balance/Radiolabel Studies
  • Cardiac Safety, TQT, Idiosyncratic Toxicity

The power of possibilities

From the ground up, Quintiles plays an essential role in helping biopharma companies like yours bring competitive drugs to market. We customize our services to help you find your edge.

Media Coverage Nov 18, 2009
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Related serivces

Phase I Units
Bioanalytical & ADME Laboratories
Model-based drug development
Video Spotlights
Getting more value from Respiratory Clinical Trials
Getting more value from Respiratory Clinical Trials
Improve Your Probability of Success
Improve Your Probability of Success
Expanded Phase I Unit in London
Expanded Phase I Unit in London
Best Practices for Optimizing Dose Escalation in First in Human Studies.wmv
Best Practices for Optimizing Dose Escalation in First in Human Studies.wmv