Clinical Research

With over 40 years of experience, more than 730 beds in North America and Europe, Celerion offers the largest global Phase 0, I and IIa clinical operations networks in the industry.

Celerion has extensive experience in First-In-Human studies having executed over 300 studies. These studies have included SAD, MAD and combination SAD/MAD study designs. With over 6,000 participants dosed, Celerion has managed First-In-Human studies of all sizes, ranging from as few as 8 to more than 190 participants.

Celerion is a market leader in Early Cardiac Services, having completed over 30 TQT and more than 100 robust QT studies. In 2010 Celerion launched the first Hybrid Phase I/ECG Core lab in the market. Integrating the ECG functions within Celerion’s Phase I clinic network, minimizing traditional ECG overhead and providing more automation, has enabled fast access to data and cost-effective solutions that deliver high-quality data for the execution of thorough QT studies and ECG assessment in SAD and MAD programs.
In an effort to improve safety for participants in clinical trials, while getting drugs to market faster for our clients, Celerion added 24 in-hospital beds to our network. This allows Celerion to conduct clinical studies in a hospital environment, while providing round-the-clock emergency care.

The exclusive alliance with BryanLGH Health Systems in Lincoln, Nebraska, provides clients the opportunity to place clinical studies in a hospital environment. The Celerion-BryanLGH Clinical Research Unit will leverage over forty years experience in conducting clinical studies utilizing the same staff, global standard operating procedures (SOPs) and institutional review board (IRB), ensuring consistency across all studies executed at Celerion facilities.

In 2011, Celerion launched the addition of a USP<797> Clean Room enables efficient execution of microtracer and microdosing studies. The USP <797> Clean Room also allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. Clients benefit by accessing quality data earlier in drug development process.

Celerion’s clinical site in Lincoln, Nebraska is licensed to conduct studies with radiolabeled compounds. In the last 10 years, Celerion’s clinical team in Lincoln, Nebraska has conducted more than 30 radiolabeled clinical trials, dosing nearly 300 subjects, successfully recruiting healthy normal males and females and elderly subjects.

Celerion collaborates with Xceleron, the leading Accelerated Mass Spectrometry (AMS) service provider in our industry, to provide solutions to the following drug development issues:

• Assessment of absolute oral bioavailability for an oral drug
• Assessment of ADME profile
• Assessment of distribution into human tissue fluids (e.g. CSF fluid for CNS, arthritic joint fluid, sputum/pulmonary lavage, saliva, tears, semen, milk, sweat)
• Perform human ADME for long half-life drugs/metabolites by using microtracer amounts as the standard mass balance radioactivity dose given is too high for healthy subjects
• Obtain ADME information in patients who cannot be studied in a phase I clinic
• Micro-dosing approach in getting early PK data under an Exploratory IND in the US (Phase 0 studies)

The company’s breadth of capabilities coupled with purpose built facilities (co-located pharmacy, clinical laboratories and flexible conduct areas) ensure the quality data is delivered on time.

Clinical Research offers clinical conduct with centralized 24-hour scheduling, rapid recruitment and thought leadership that includes broad therapeutic area expertise.