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Celerion

Lincoln, Nebraska, US

In Applied Translational Medicine, Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.

The name Celerion is derived from the Latin celeritas meaning swiftness and speed. Our name reflects our founding principle – to help our clients get their products to the market faster.

Celerion’s focus is on the implementation of innovative strategies to generate key data very early to enable go/no-go decisions in drug development. With a large clinical capacity of more than 600 beds (24 in-hospital), efficient bioanalytical laboratories and experienced scientific staff, Celerion offers one of the most experienced clinical pharmacology research networks in the industry.

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Medical Device Clinical Trials
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eCTD Services
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Medical Writing
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Celerion is committed to delivering high quality reports within the established timelines facilitated by our team of medical writers with extensive clinical experience and qualifications, including PhDs, public health, nursing and science degrees.

This clinical knowledge is an invaluable component of the skills required to... Show more »

Celerion is committed to delivering high quality reports within the established timelines facilitated by our team of medical writers with extensive clinical experience and qualifications, including PhDs, public health, nursing and science degrees.

This clinical knowledge is an invaluable component of the skills required to produce a high-quality clinical study report. The medical writing team’s broad background in pharmacology, physiology, therapeutics, and acute and chronic diseases ensures that the medical writer looks beyond the basic safety analysis and considers other factors that may cause or contribute to clinical results. The team works closely with the physicians and principal investigators to ensure reporting accuracy.

To further enhance the scientific input for protocols and reports, Celerion has consolidated the study design/protocol development scientists and medical writers into the same team. This approach has improved the accuracy of data and shortened project timelines.

Comprehensive medical writing and reporting services:

  • Generate and verify preferred term coding of adverse events, medical/surgical histories and concomitant medications
  • Written interpretation of safety results for ICH-compliant study reports
  • eCTD- and ICH E3-compliant clinical study reports
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Clinical PK/PD Studies
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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.

Additionally, the team conducts non-compartmental and compartmental PK/PD analyses using data derived from plasma, whole blood, urine and other... Show more »

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.

Additionally, the team conducts non-compartmental and compartmental PK/PD analyses using data derived from plasma, whole blood, urine and other potential physiologic matrices.

Celerion stays informed on best practices and industry standards to ensure consistent delivery of timely, high-quality analyses and reports. Celerion utilizes leading industry software such as WinNonlin® and other proprietary programs to provide the most accurate assessment of key PK parameters from studies on bioavailability, bioequivalence, food effect, drug-drug interactions, dose escalation and thorough QT studies.

Our scientists are committed to supporting the analysis and reporting of data through final approval and during regulatory review. Celerion complies with the evolving regulatory framework in all major markets, which enables us to address challenging questions from regulatory agencies from across the globe.

Comprehensive PK and PD services:

  • Study design input
  • PK and PD analysis and parameter calculation
  • Written interpretation of PK and PD results for ICH study reports
  • Consultation on PK/PD topics
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Clinical Data Management
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The key focus for our clinical data sciences team is to deliver high-quality data, while maintaining rapid timelines.

Celerion provides full clinical data sciences services from the creation of data collection forms and standards through provision of high-quality analyzable data under expectations of the CDISC... Show more »

The key focus for our clinical data sciences team is to deliver high-quality data, while maintaining rapid timelines.

Celerion provides full clinical data sciences services from the creation of data collection forms and standards through provision of high-quality analyzable data under expectations of the CDISC guidelines.

Celerion’s team has extensive experience and expertise in early clinical development, and has developed robust processes and SOPs to ensure we deliver high-quality data.

In addition to the extensive number of clinical pharmacology studies the team has managed, they have also focused on many special populations including but not limited to oncology, hepatic-impaired, renal-impaired and cardiac-impaired patients.

The clinical data sciences team offers the flexibility of our proprietary ClinQuick® electronic data acquisition system for studies conducted at Celerion, however, are fully capable of handling data from clinical studies conducted at third party sites.

Comprehensive services include:

  • Electronic data management using ClinQuick® and commercially available EDC systems
  • CRF designs in accordance with CDASH standards
  • Complete data cleaning services including data reviews, logic checks and query management
  • Full use of CDISC data standards including CDASH and SDTM data files
  • ADaM datasets to facilitate “One PROC away” analysis programs
  • Case Report Tabulation and Electronic Case Report Form deliverables for e-Submissions
  • Minimum submissions standards for legacy studies
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PK/PD Study Design
Pharmacokinetics/Pharmacodynamics Study Design
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In this highly competitive environment, it is essential to gain as much information as fast as possible from early phase clinical studies to make go/no-go decisions quickly and with confidence. Our scientists use industry-leading study designs that reduce time from First-in-Human to clinical proof-of-concept. This approach... Show more »

In this highly competitive environment, it is essential to gain as much information as fast as possible from early phase clinical studies to make go/no-go decisions quickly and with confidence. Our scientists use industry-leading study designs that reduce time from First-in-Human to clinical proof-of-concept. This approach maximizes the amount of information gathered from one study and reduces overall costs, without jeopardizing the integrity of primary and secondary objectives.

Working with other scientists and medical experts within our company, our highly skilled team of protocol-development scientists uses cutting-edge adaptive and fusion study designs to integrate objectives that traditionally have been evaluated in multiple studies. For example, by adding a patient component to an ascending dose study, we can evaluate PK and PD activity in the target population early in the drug development stage and provide you with preliminary findings on the efficacy of the compound.

Comprehensive study design and protocol-development services include:

  • Study protocols and amendments
  • Feedback and review of client-provided protocols
  • Consultation for study design
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Data Modeling
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In silico methods have been identified as part of the solution to more efficient drug-development programs.

The Data Management and Biometrics team performs population PK/PD analysis with animal and human data, from Celerion sites and external partners. Data are analyzed using NONMEM®, ADAPT-5®, SAS® and R®. Population PK/PD... Show more »

In silico methods have been identified as part of the solution to more efficient drug-development programs.

The Data Management and Biometrics team performs population PK/PD analysis with animal and human data, from Celerion sites and external partners. Data are analyzed using NONMEM®, ADAPT-5®, SAS® and R®. Population PK/PD modeling and simulation allow for cost and time savings compared with running additional clinical studies to obtain information needed to move forward with clinical development.

Once a model is established with all key elements, simulations can be made, allowing for selection of future dosing regimens and optimal sampling strategies. This enables efficient, cost-effective and scientifically sound study designs that help get your drugs to market faster.

Comprehensive modeling and simulation services:

  • Population PK/PD modeling and simulation
  • Development of programs from preclinical to First-in-Human PK for NDA submission
  • Guidance for future studies by optimizing study designs regarding dose selection, population selection, sampling schedule, drug-drug interactions, etc.
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Clinical Cardiac Safety and QT Studies
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Precise evaluation of the QT interval is important in evaluating arrhythmia potential of a compound. However there are multiple off target effects of compounds which may provide a more comprehensive assessment of cardiovascular safety.

Celerion provides the following services:

Precise evaluation of the QT interval is important in evaluating arrhythmia potential of a compound. However there are multiple off target effects of compounds which may provide a more comprehensive assessment of cardiovascular safety.

Celerion provides the following services:

  • Comprehensive services for planning, implementation and execution of Thorough QT (TQT) and Intensive ECG studies
  • Noninvasive imaging including nuclear perfusion studies, cardiac computed tomography(CT), Cardiac Magnetic resonance imaging(CMRI), Cardiac Positron Emission Tomography(PET) and 2/3 Dimensional Echocardiography
  • Graded exercise testing
  • Flow mediated dilation
  • Platelet Aggregation
  • Ambulatory blood pressure monitoring

Extensive Experience

  • Completed over 57 TQT and over 400 intense ECG studies demonstrates thorough understanding of dosing requirements, study design, conduct and study-group sizes
  • Full suite of service offerings including protocol development, clinic conduct, ECG analysis, data management, fully integrated statistical analysis, study reports, regulatory submission support and ECG warehouse upload
    • These integrated services ensure production of the highest-quality data, turn-key operations and process efficiencies, which result in cost savings

Unparalleled Expertise

  • Cardiac safety experts available for pre-study and post-study regulatory support
    • Chief Cardiologist and Global Medical Director with experience reading over 1 million ECGs for the pharmaceutical industry
    • Senior Director of Cardiac Services with over 10 years of hands-on experience
    • Principal Biostatistician with over 20 years’ early clinical experience. Dedicated to the statistical analysis of robust QT and TQT studies for over 10 years
  • For studies requiring extensive cardiac monitoring, Celerion offers the expertise to guide you from development through submission
    • Thorough understanding of dosing requirements, study execution, design, sample size calculations and study-group sizes
  • Optimized cardiac safety data collection resulting in lower variability – participant QTc standard deviation of 6msec versus industry average of approximately 10msec, means smaller study sizes and therefore, lower cost
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Clinical Validation of Diagnosis
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Statistical Analysis
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Product Stability Testing
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Regulatory Affairs Consulting
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Celerion’s experienced global regulatory team helps companies execute sophisticated regulatory processes with strategic and tactical support to meet clients’ objectives and to ensure high quality regulatory documentation and timely communication with regulatory agencies.

Our team offers direct regulatory support for drug,... Show more »

Celerion’s experienced global regulatory team helps companies execute sophisticated regulatory processes with strategic and tactical support to meet clients’ objectives and to ensure high quality regulatory documentation and timely communication with regulatory agencies.

Our team offers direct regulatory support for drug, biological products and medical devices for submissions to North American and European authorities. Services offered include customized regulatory consulting, regulatory submissions preparation, medical and technical writing and global regulatory liaison.

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Radiotracers and Radiopharmaceuticals
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Quality Assurance
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In vivo PK/PD Studies
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Celerion’s facility in Lincoln, Nebraska is licensed to conduct studies with radiolabeled compounds. 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... Show more »

Celerion’s facility in Lincoln, Nebraska is licensed to conduct studies with radiolabeled compounds. 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. This service ensures high total recovery of radioactive dose while providing for efficient clinical study conduct.

Celerion has the capabilities to manage all aspects of human radiolabeled ADME studies from synthesis and formulation of an appropriate radiolabeled drug through dosimetry assessment and clinical conduct to final isolation, identification and quantification of metabolites in the samples collected. Celerion has access to a skilled radiochemical synthesis group as well as to specialists in metabolite isolation and identification from biomatrices. Radiolabel dosage forms suitable for administration to humans can be readily prepared at Celerion’s purpose-built pharmacy clean room at the Lincoln facility. The Lincoln clinic can also conduct micro-radiotracer studies, making it one of the few organizations globally capable of conducting specialized human ADME studies to regulatory standards.

The on-site bioanalytical and Phase I clinical facilities in Lincoln offer seamless integration of services and data. For bioanalytical analyses, the ADME suite interfaces with Celerion’s global electronic notebook system thereby increasing data compliance.

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Preclinical Efficacy Studies
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Preclinical Study Design
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In vivo Pharmacology Studies
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Patient Recruitment
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Across our four clinical facilities, Celerion has an active subject database of more than 128,000 healthy males and females.

To augment our subject database and target a specific therapeutic area, Celerion applies a combination of mass media marketing and direct marketing outreach. These efforts also include accessing the large... Show more »

Across our four clinical facilities, Celerion has an active subject database of more than 128,000 healthy males and females.

To augment our subject database and target a specific therapeutic area, Celerion applies a combination of mass media marketing and direct marketing outreach. These efforts also include accessing the large pool of subjects in our active recruiting database. Examples of executed marketing methods include print, radio, television and Web advertising as well as health fairs, sponsorships and seminars.

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. In addition, we use integrated recruiting teams across all four sites, allowing for more synergistic recruiting efforts supporting multi-site studies.

Celerion has developed partnerships and relationships with local doctors and hospitals to refer patients as appropriate for studies requiring special populations.

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Microdosing
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Microbiology Testing
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Material Testing Services
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Mass Spectrometry
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IND/NDA/BLA Submission
Investigational New Drug/New Drug Application Submission
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In vivo Immunotoxicity Testing
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Immunobiology Services
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Drug Potency and Efficacy Testing
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Drug Discovery
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Drug Development
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Celerion’s Drug Development Services helps pharmaceutical and biotechnology companies demonstrate early evidence of their compounds’ clinical efficacy and tolerance in humans.

The knowledge and leadership of highly trained scientists enable clients to design and carry out comprehensive development strategies. Celerion’s... Show more »

Celerion’s Drug Development Services helps pharmaceutical and biotechnology companies demonstrate early evidence of their compounds’ clinical efficacy and tolerance in humans.

The knowledge and leadership of highly trained scientists enable clients to design and carry out comprehensive development strategies. Celerion’s integrated service spans the research process for small and large molecule drugs from lead identification through clinical proof-of-concept – and all the way to full clinical development.

Celerion offers expertise in pharmacology, chemogenomics, drug metabolism, pharmacokinetics, analytical chemistry, toxicology and safety pharmacology, bioanalysis, clinical pharmacology, biomarker strategies, early clinical research, regulatory strategy and submissions support, including CMC sections of regulatory documents.

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Phase II Clinical Trials
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Partnering with Celerion means working with one of the most experienced CROs in the world.

  • 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.
  • A 24-bed clinic located within a hospital brings access... Show more »

Partnering with Celerion means working with one of the most experienced CROs in the world.

  • 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.
  • A 24-bed clinic located within a hospital brings access to medical specialists, imaging capabilities and intensive medical support for those studies that require specialized care and procedures.
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De Novo Drug Design
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Drug Delivery Systems
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Phase I Clinical Trials
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Partnering with Celerion means working with one of the most experienced CROs in the world.

  • 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.
  • A 24-bed clinic located within a hospital brings access... Show more »

Partnering with Celerion means working with one of the most experienced CROs in the world.

  • 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.
  • A 24-bed clinic located within a hospital brings access to medical specialists, imaging capabilities and intensive medical support for those studies that require specialized care and procedures.
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Clean Room Services
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Celerion uniquely offers a USP -compliant Clean Room as part of our Phase I core capabilities. Our onsite pharmacists have also been certified to meet USP guidelines.

This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile... Show more »

Celerion uniquely offers a USP -compliant Clean Room as part of our Phase I core capabilities. Our onsite pharmacists have also been certified to meet USP guidelines.

This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile preparation and administration allows a one-stop option for our clients, thereby saving time and money.

A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP Clean Room allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.

The unique design of this Clean Room includes three separate areas, one ante-room that serves two individual clean rooms. One clean room is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding. An additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.

The clean room when combined with our Lincoln, NE, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.

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Gas Chromatography (GC)
Gas Chromatography
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Human Blood Collection Service
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Biostatistical Analysis
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Celerion’s team of highly qualified statisticians routinely performs a large number of statistical analyses to deliver high-quality, submission-ready data for regulatory agencies.

Celerion’s statisticians are intricately involved in study design, CRF design, data import/export and data cleaning and review and are often... Show more »

Celerion’s team of highly qualified statisticians routinely performs a large number of statistical analyses to deliver high-quality, submission-ready data for regulatory agencies.

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.

SAS programmers perform statistical programming and data programming, as well as providing tables, figures and listings (TFLs) based on the analyses and format specified in the Statistical Analysis Plan, following either Celerion standards or client-specific requirements.

To ensure on-time delivery of quality data, Celerion has developed standard programs, analysis codes and output formats, in addition to a large number of macros to compile SAS output and streamline data delivery. In addition, data flow within Celerion systems (clinical, bioanalysis and PK/statistics) is automated and error proof.

Comprehensive biostatistics services:

  • Input on sample sizes and analysis of endpoints
  • Detailed statistical analysis plans
  • TFL generation including required statistical analysis
  • Consultation on statistical topics
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Biopharmaceutical Development
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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.

Celerion guides clients through the complex development process, including:

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.

Celerion guides clients through the complex development process, including:

  • Extensive experience in assays of human insulins, interleukins, interferons, pegylated interferons, erythropoetins, monoclonal antibodies and fusion proteins
  • Extensive expertise in the monitoring and quantification of antigenicity (anti-drug antibodies) in samples from animal and human clinical studies
  • PK/PD assessment of biological products in patients and healthy subjects
  • Regulatory expertise to guide full biosimilar development programs
  • Full program development leadership and/or ad hoc consulting services spanning preclinical to pivotal clinical studies

Celerion’s biosimilars team provides expertise in the following areas:

  • Antigenicity, immunotoxicology and immunogenicity
  • Bioanalytical assay development (preclinical and clinical)
  • Developing preclinical and clinical study designs
  • Regulatory guidance and preparation of clinical programs
  • Program management

Benefits of leveraging Celerion’s biosimilars experience and expertise:

Celerion’s biosimilars team members include experienced:

  • Pharmacologists/Toxicologists
  • Bioanalytical scientists
  • Certified project managers
  • Clinical pharmacologists and therapeutic area experts
  • Former regulatory agency reviewers

Two global laboratories located in Europe (Zurich, Switzerland) and the USA (Lincoln, NE)

  • Small and large molecule assays, biomarkers and immunogenicity tests
  • Only CRO with global harmonized electronic laboratory notebook
  • Technologies include: ELISA, RIA, ECLA, Luminex, LC-MS/MS

Three global clinical Phase I and II facilities located in Europe (Belfast, Northern Ireland, UK) and the USA (Lincoln, NE; Phoenix, AZ)

  • Over 600 beds (including 24 in-hospital) and conduct over 200 complete studies annually
  • Executed over 6,000 Phase I studies conducted globally
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Biomarker Discovery
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Biopharmaceutical Process Development
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Biological Testing
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Bioanalytical Analysis LC/MS/MS
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Assay Development
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Analytical Chemistry Services
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Bioanalysis
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Experimental Design
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Drug Discovery & Development
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Animal Models and Studies
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Computational Modeling
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Laboratory and Facility Management Services
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Hit Identification
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Chemistry and Materials
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Imaging & Spectroscopy
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Human Biospecimen Collection
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Formulation Services
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Biology
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Immunoassays
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Biomarkers
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Radiochemistry
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Cells and Tissues
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Clinical Validation Services
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Product Testing Services
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Product Quality Control
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Spectroscopy
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Regulatory Affairs Services
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Bioanalytical Assays
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Cleaning & Sterilization Services
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Manufacturing Services
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Toxicology
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Bioavailability and Bioequivalence Studies
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Editorial and Writing Services
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Biospecimens
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Biostatistics & Bioinformatics
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Purification Services
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Marketing, Communication & Graphic Design Services
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Clinical Data Collection, Analysis and Management
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Clinical Trials, Consulting, and Management
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Chromatography
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Pharmacology & Toxicology
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Project and Process Management
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In vivo Toxicity Testing
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Clinical Research
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Process Consulting
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Product Development, Testing, and Packaging
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