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    Pharma Services Category of Celerion

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    01 BioAnalytical Services (3)

    02 Clinical Development / Phase IIb-IV (3)

    03 Compliance, Regulatory & Consulting (2)

    04 Early Clinical / Phase I-IIa (4)

    05 Patient / Investigator Recruitment (1)

    06 Technology / Data / Analytics (3)

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    01 Celerion (16)

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    01 U.S.A (16)

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    Celerion

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    RADIOLABELED ADME STUDIES

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    In response to a growing interest in conducting human 14C-radiolabeled ADME studies earlier in drug development, Celerion has expanded its ADME suite in Lincoln, Nebraska.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    BIOANALYTICAL TESTING SERVICES

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    Celerion is experienced in the bioanalysis of large molecules, biomarkers, proteins & biosimilars. It offers bioanalytical development services, bioanalytical testing services, method development and validation for drug development.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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    ACTIVE RECRUITING DATABASE

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    On average, Celerion screens more than 2,300 subjects per month. This success rate is attributed to our experienced staff, our extensive recruiting efforts and our ability to understand both the study requirements and the local subject pool for each of our clinical facilities.

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    Pharma Service: Clinical Trials

    Category: Patient / Investigator Recruitment

    Sub Category: Patient Recruitment
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    DATA MANAGEMENT & BIOMETRICS

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    Data Management and Biometrics at Celerion bridges the gap between medical practice and laboratory science by assessing the safety of drug products to maximize drug effects and minimize side effects.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    PHARMACOKINETICS / PHARMACODYNAMICS (PK/PD)

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    Celerion’s team of clinical pharmacologists has extensive expertise in PK/PD data assessment and consults with clients on the appropriate analytical approach for clinical studies.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    GENERIC DRUGS / BIOSIMILARS

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    Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Bioavailability / Bioequivalence
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    BIOSTATISTICS

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    Celerion’s statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often consulted to perform special calculations and summarizations of information for non-study-related issues for problem solving and process improvement.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Clinical Biostatistics and Programming
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    14C-RADIOLABELED MICROTRACER STUDIES

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    Celerion’s clinic in Lincoln, Nebraska, is the only Phase I facility in North America with proven experience to release radiolabeled drug to regulatory standards that has been formulated on site for intravenous use in humans. This is required to perform assessments of absolute bioavailability

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    GLOBAL CRO- PHASE I & LL STUDIES

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    With over 40 years of experience, more than 600 beds in North America and Europe, Celerion offers the largest global Phase I and II clinical operations networks in the industry.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Phase I / IIa
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    BIOPHARMACEUTICAL DEVELOPMENT

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    Celerion consults in the scientific and regulatory phases of biopharmaceutical product development. Our scientists are very engaged in the practical interpretation of the requirements for biosimilar drugs emerging in Europe.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Biopharmaceuticals
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    BIOMARKER & PEPTIDE BIOANALYSIS

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    Celerion offers bioanalysis services for large molecules, biomarkers & peptides. It provides bioanalytical testing services, bioanalytical method development, bioanalytical method validation services & sample analysis for drug development.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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    LARGE MOLECULES & BIOMARKERS BIOANALYSIS

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    Celerion is experienced in the bioanalysis of large molecules, biomarkers, proteins & biosimilars. It offers bioanalytical testing services, bioanalytical method development, bioanalytical method validation, and sample analysis for drug development.

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    Pharma Service: Analytical

    Category: BioAnalytical Services

    Sub Category: Bioanalytical & Biomarker Testing Services
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    BIOSIMILARS

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    Celerion leverages more than 30 years of biologics drug development experience to enable early assessment viability of biosimilars, and bridge the gap between newly sourced products and patient studies.

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    Pharma Service: Clinical Trials

    Category: Clinical Development / Phase IIb-IV

    Sub Category: Bioavailability / Bioequivalence
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    ELECTRONIC LABORATORY NOTEBOOK SYSTEM

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    Electronic laboratory notebook enables faster access to data and improved information quality due to centralized data repositories.

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    Pharma Service: Clinical Trials

    Category: Technology / Data / Analytics

    Sub Category: Data Management
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    ADME / MASS BALANCE

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    The ADME (Absorption, Distribution, Metabolism and Excretion) Suite includes new state-of-the-art equipment and laboratory space to perform on-site scintillation counting allowing for radioactivity recovery results to be delivered in real-time.

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    Pharma Service: Clinical Trials

    Category: Early Clinical / Phase I-IIa

    Sub Category: Pharmacokinetics / Pharmacodynamics / Pharmacometrics
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    GLOBAL REGULATORY SERVICES

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    Leveraging our regulatory experience and familiarity with the tobacco industry, allows us to assist clients as they navigate the evolving regulatory pathway toward product approval.

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    Pharma Service: Clinical Trials

    Category: Compliance, Regulatory & Consulting

    Sub Category: Tobacco
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