Celerion

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  • Newsletter: Q2 2018

  • Industry Leading Nicotine Researcher Joins Celerion Research Team

    Industry Leading Nicotine Researcher Joins Celerion Research Team

    Dr. Ian Fearon further enhances Celerion’s renowned capabilities

    Lincoln, NE (January 23, 2018) – Celerion, the leader in Nicotine Clinical Research Services, is pleased to announce that Dr. Ian M. Fearon has joined Celerion’s industry leading Nicotine Research Team.

    Prior to joining Celerion, Dr. Fearon was Principal Scientist and Head of Clinical Research at British American Nicotine R&D where he was responsible for defining the strategy for developing and implementing clinical research programs in support of regulatory submissions and product launches.  During his long career at British American Nicotine, Dr. Fearon published extensively in prestigious, peer reviewed journals such as International Journal of Clinical Trials, BMC Public Health, American Journal of Health Behavior, Regulatory Toxicology & Pharmacology and many others.

    Celerion’s capabilities support all elements of nicotine research from regulatory consulting to clinical development, bioanalysis, data analysis and reporting. Dr. Fearon will be joining the elite Celerion scientific team which includes Dr. Donald Graff, Director Nicotine Research, and Kirk Newland, Technical Director Nicotine Science.  Over the past 17 years, the Celerion nicotine team has designed, consulted on, or analyzed data for more than 100 clinical studies, including large multi-site trials that have contributed to the development of potential reduced harm nicotine products. In addition to our two purpose-built facilities, strategically located in the US and EU, Celerion has cultivated a network of U.S. sites equipped to handle the unique requirements specific to larger nicotine product evaluations. Celerion’s world leading bioanalytical laboratory offers extensive expertise in the assessment of nicotine constituents, having analyzed over 500,000 samples in the past 3 years. Celerion has made significant investments in the area of nicotine harm reduction research, including a patented approach for testing e-cigarettes using stable isotope solvents.

    Celerion, a leader in clinical research services, is a global company with over 1,000 employees worldwide. Our unique combination of medical expertise, clinical operations experience and scientific excellence provides our customers with the confidence to make fast, accurate decisions about their product development path within the clinical research process.  Our founding mission is to help our clients get their products to market quickly, impacting public health needs around the world. For more information please visit www.celerion.com.

    CONTACT:
    Leslie C. Poli
    Senior Director
    M: +1 919 324 4397
    leslie.poli@celerion.com

     

  • Celerion Creates a Fully Automated, Early Development Clinical Trial Data Management Platform

    Celerion Creates a Fully Automated, Early Development Clinical Trial Data Management Platform

    Celerion Creates a Fully Automated, Early Development Clinical Trial Data Management Platform

    Lincoln, NE (January 17, 2018) – Celerion, the leader in early clinical development, is pleased to announce a new core capability for this growing market: the integration of ClinQuick®, Celerion’s proprietary electronic data acquisition system, with TrialMaster®, OmniComm’s electronic data capture solution, to provide a fully automated clinical trial data management platform.

    The dynamic exchange of information between late pre-clinical efforts and early stage clinical trials is critical to accelerating the transition from first in human through to proof of concept patient studies.

    Celerion utilizes TrialMaster as the preferred electronic data capture (EDC) system for data capture on multi-site studies, and ClinQuick to capture bar-coded data for studies conducted in Celerion clinics. Integrating ClinQuick into TrialMaster automates Celerion’s data acquisition system and provides consistent data management and reporting capabilities in one centralized database. It facilitates consistency of data collection across clinical sites, ensuring accurate and high-quality information.

    This integrated solution provides a comprehensive data management platform to access ClinQuick’s bar-coded data, and enable dynamic risk monitoring, robust query management, ad hoc reporting and data extraction in portable industry formats. It has also been incorporated into Celexus, Celerion’s client portal for real-time access to all clinical study data.

    “Merging our proprietary electronic data acquisition system with an electronic data capture system is a revolutionary advancement that has not been seen before in early clinical research,“ said Michelle Combs PhD, Vice President of Data Management and Biometrics. “This automated solution minimizes the need for manual data entry and delivers a centralized data management platform that meets growing client expectations for speed and transparency.”

    “This innovative approach continues to signal to our clients and the market, Celerion’s strong commitment to technological progress and to understanding our clients’ challenges,“ said Susan Thornton PhD, President and CEO. “Integrating these solutions improves operational efficiency and makes it easier for our clients to make data-driven decisions to help move their clinical programs forward.”

    About Celerion

    Celerion, a leader in early clinical research services, is a global company with over 1,000 employees worldwide. Our unique combination of medical expertise, clinical operations experience and scientific excellence provides our customers with the confidence to make fast, accurate decisions about their drug development path within the clinical research process. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information please visit www.celerion.com.

    Media Contact:
    Michelle Maklas-Baker
    Manager, Global Marketing
    +1 732-306-7804
    media.inquiries@celerion.com 

  • Newsletter: Q1 2018

  • Prediabetes, the New Normal in Early Clinical Research

    Prediabetes, the New Normal in Early Clinical Research

    Prediabetes, the New Normal in Early Clinical Research

    There is a growing shift in inclusion criteria from healthy normal subjects to patient groups in early drug development. For programs with a chronic metabolic disease investigational product, prediabetes subject enrollment in early phase studies can facilitate the detection of efficacy signals and proof-of-concept [1].

    Prediabetes describes a state of glucose impairment which holds a significant risk of developing type 2 diabetes. According to the CDC, 1 in 3 Americans have prediabetes, yet only 1 out of 10 individuals are aware of their condition [2]. Risk factors for prediabetes include being overweight or obese, an estimated 80% of subjects with glucose impairment are overweight or obese [3].  Additional risk factors include 45 years of age or older, a family history of type 2 diabetes, a sedentary lifestyle, and previously having gestational diabetes [2]. Clinical research organizations can provide a helping hand in managing the disease by being committed to raising prediabetes awareness through free A1c screening during community outreach events [4] and offering resources on diabetes prevention.

    Type 2 diabetes patients can be vulnerable to hyperglycemic and hypoglycemic events during early phase placebo-controlled studies, monotherapy studies or during washout periods. Since prediabetes subjects maintain a degree of glucose control, they are less likely to experience severe glucose excursions. Therefore, a risk mitigation strategy to minimize serious glycemic changes in early dose escalation studies could include the enrollment of prediabetes subjects. In addition, to better understand a drug’s effect on glycemic parameters, intensive daily glucose tracking through continuous glucose monitoring (CGM) can provide blood glucose readings every 5-15 minutes for up to 2 weeks. To this end, CGM is recognized as the “ECG Holter-monitor for glycemia” [5].

    Nonalcoholic fatty liver disease (NAFLD) is the next major health epidemic and prediabetes is strongly associated with hepatic inflammation and fibrosis in NAFLD subjects [6]. Nonalcoholic steatohepatitis (NASH), a deleterious form of the disease can lead to liver cirrhosis, end-stage liver failure and even hepatocellular carcinoma. Using non-invasive techniques to assess steatosis, inflammation and oxidative stress, and fibrosis can expedite clinical research. These pharmacodynamic imaging and soluble biomarker analyses are essential early signals of drug efficacy to enable faster go/no-go decisions.

    Prediabetes subject enrollment in early clinical studies for weight management, Type 2 Diabetes or NASH indications offers an opportunity to examine pharmacodynamic endpoints in a population of interest while minimizing safety concerns typically observed with patient studies.

    References

    1. Paglialunga, S. The Impact of Prediabetes on Early Clinical Metabolic Disease Studies: Celerion, Technical Note. 2017.

    2. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA. 2014.

    3. Tuso P. Prediabetes and lifestyle modification: time to prevent a preventable disease. Perm J. 2014;18(3):88-93.

    4. Jaycox SH, Esposito M, Paglialunga S. Effectiveness of Community-Based HbA1c Screening as a Clinical Study Recruitment Tool. American Society for Clinical Pharmacology and Therapeutics; 2017 April 17 Washington,DC.

    5. Vigersky R, Shrivastav M. Role of continuous glucose monitoring for type 2 in diabetes management and research. J Diabetes Complications. 2017;31(1):280-7.

    6. Yilmaz Y, Senates E, Yesil A, Ergelen R, Colak Y. Not only type 2 diabetes but also prediabetes is associated with portal inflammation and fibrosis in patients with non-alcoholic fatty liver disease. J Diabetes Complications. 2014;28(3):328-31.

  • Newsletter: Q4 2017

  • Newsletter: Q3 2017

  • Celerion Receives a 2017 CRO Leadership Award in Multiple Categories for Clinical Research Excellence

    Celerion Receives a 2017 CRO Leadership Award in Multiple Categories for Clinical Research Excellence

    Lincoln, NE (June 20, 2017) — Celerion, a leading clinical research organization, is pleased to announce it has received a CRO Leadership Award for the fourth time by global biopharmaceutical executives in Life Science Leader’s annual CRO Leadership Awards for 2017.

    Both large and small biopharmaceutical clients acknowledged Celerion as a CRO Leader in all five categories: Capabilities, Compatibility, Expertise, Quality and Reliability.

    Celerion was distinguished amongst 72 of their peers in the annual Contract Research Quality Benchmarking online survey conducted by Industry Standard Research. The survey queried the direct client experience across 27 different performance metrics spanning technical expertise to client service; results have been published in the May edition of Life Science Leader magazine.

    Additionally, Individual Attribute Awards were developed in response to the intangible capabilities that were identified as critical to successful collaborations. Celerion was also recognized for achievement in Data Quality, Innovative Solutions and Operational Excellence.

    Commenting on the news, Susan Thornton, President and CEO of Celerion said, “We would like to thank our clients for this recognition and their continued partnership with Celerion. For over 40 years Celerion has been at the forefront of early clinical research. Winning the CRO Leadership award highlights the value we consistently deliver to our clients. Our extensive experience and expertise in managing complex early phase studies in healthy volunteers and patients enables us to provide unique insights for successful clinical development programs.”

    About Celerion

    Translating science into medicine, Celerion is a premier provider of early clinical research and translational clinical pharmacology sciences from their global locations in North America, Europe and Asia.

    Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labeling. With purpose-built clinic and laboratory facilities and highly automated technology, Celerion provides full study services including clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services, medical writing, and regulatory and drug development program management. For more information please visit www.celerion.com.

    Media Contact:
    Karen Wills
    Executive Director, Global Marketing
    +1 508 808 9825
    media.inquiries@celerion.com 

  • Newsletter: Q2 2017

  • Celerion Implements Biometric Fingerprint Technology and Marks Five-Year Anniversary with Verified Clinical Trials

    Celerion Implements Biometric Fingerprint Technology and Marks Five-Year Anniversary with Verified Clinical Trials

    Lincoln, NE; March 14, 2017 – Celerion, the premier provider of innovative early clinical research solutions, is pleased to announce that it has implemented Verified Clinical Trials (VCT) biometric fingerprint technology to prevent dual enrollment in clinical trials.

    Celerion was the first early-stage contract research organization (CRO) to partner with VCT to improve participant safety and clinical trial data. Over the last five years, Celerion performed nearly 50,000 verifications utilizing the VCT global clinical database registry to identify participants that are currently enrolled in other clinical studies.

    Most recently, Celerion implemented VCT’s biometric fingerprint technology to augment the accuracy and speed of the verifications performed at their facilities. The use of biometrics adds another layer of protection to ensure dual enrollment in clinical trials does not occur.

    “Our focus has always been to help our clients get their drugs to market and protect the safety and well-being of our participants. The VCT database registry enhances our ability to achieve both of those objectives,” said Phil Bach, Vice President, Global Clinical Research, Celerion. “Celerion and VCT share the same vision of applying scientific expertise and advanced technology to ensure the safety of our participants and maintain data integrity leading to successful clinical trial outcomes.”

    “Following Celerion’s lead, the majority of Phase I units across North America now utilize the VCT system every day to protect their clinical trials. VCT offers the most comprehensive and unique clinical research subject database registry to enhance the quality of both early and late stage studies globally. The system provides a level of safety to the clinical trial process that could not be attained without a solution like VCT,” said Mitchell Efros, MD FACS, CEO at VCT.

    “By joining forces five years ago, Celerion and VCT led the way in providing a solution that maximizes detection of attempted duplicate enrollment and protocol violations. This combined effort raised awareness and utilization across all phases of clinical research highlighting the need for a research subject database in the clinical trials industry. Working with Celerion’s team over the past five years has been a pleasure,” added Kerri Weingard, COO at VCT.

    About Celerion
    Translating science into medicine, Celerion is a premier provider of early clinical research and translational clinical pharmacology sciences from their global locations in North America, Europe and Asia.

    Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labeling. With purpose-built clinic and laboratory facilities and highly automated technology, Celerion provides full study services including clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services, medical writing, and regulatory and drug development program management. For more information please visit www.celerion.com.

    About Verified Clinical Trials
    Verified Clinical Trials is a forward-thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials.  Verified Clinical Trials defines itself as the world’s leader in the field of database registries in clinical trial research.  Verified Clinical Trials is the only clinical research database registry designed specifically to enhance the quality of both early and late phase trials and has the scalability to reach all sites nationally as well as on a global level.  Verified Clinical Trials offers numerous other value added services to the clinical research site, CRO, and Pharmaceutical Sponsor, that prove invaluable with regards to financial and legal issues and liabilities. For more information visit www.verifiedclinicaltrials.com.

    Media Contact:
    Michelle Maklas-Baker
    Manager, Global Marketing
    +1 732-306-7804
    media.inquiries@celerion.com