Celerion

Lincoln, NE, United States
Lincoln, NE, United States

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Industry Standard Research (ISR) has released a new report, CRO Quality Benchmarking - Phase I Service Providers (9th Edition), containing findings focused on service provider selection and evaluation. Kevin Olson, CEO, explains, "While some outsourced Phase I projects may lend themselves to a straightforward CRO selection, there are many instances where a sponsor's 'go-to' CRO isn't the right fit for the job and outsourcers must venture into uncharted waters to find a provider. This is where having access to experiential data becomes critical. Understanding the strengths and weaknesses of Phase I CROs as rated by their customers is paramount in choosing the right CRO for a project." ISR surveyed 240 decision-makers at sponsor organizations to gather a comprehensive view of the Phase I service provider landscape. Respondents assess the importance of 27 selection drivers (detailed below) to paint a picture of what is most important in their service provider selection process. Then, respondents evaluate service provider performance along the same dimensions. Using the selection driver data and performance ratings in tandem provides an opportunity for readers to gain a deep understanding of the Phase I outsourcing process and its players. "Similar to how one might read automobile reviews written by other drivers before buying a car, assessing how well a CRO has performed for recent users can help outsourcing decision-makers choose an appropriate Phase I CRO," states Olson. "The performance of a couple of Phase I CROs stands out. Celerion receives high marks for its performance in the Organization Factors category while SGS Life Sciences is noted for its performance in Staff Characteristics." High performers in Budget Factors, Delivery Factors, and Timelines Management categories are available in the full report. In addition to service provider selection drivers and performance ratings, this report offers insights into the use of preferred providers, cost perceptions/experience, and loyalty metrics, among other areas. For more information on ISR's CRO Quality Benchmarking - Phase I Service Providers (9th Edition) report, please visit ISR's report page here. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's Web site at www.ISRreports.com, email info@ISRreports.com, or follow ISR on Twitter @ISRreports.


CARY, NC / ACCESSWIRE / May 17, 2017 / Industry Standard Research (ISR) has released a new report, CRO Quality Benchmarking - Phase I Service Providers (9th Edition), containing findings focused on service provider selection and evaluation. Kevin Olson, CEO, explains, "While some outsourced Phase I projects may lend themselves to a straightforward CRO selection, there are many instances where a sponsor's 'go-to' CRO isn't the right fit for the job and outsourcers must venture into uncharted waters to find a provider. This is where having access to experiential data becomes critical. Understanding the strengths and weaknesses of Phase I CROs as rated by their customers is paramount in choosing the right CRO for a project." ISR surveyed 240 decision-makers at sponsor organizations to gather a comprehensive view of the Phase I service provider landscape. Respondents assess the importance of 27 selection drivers (detailed below) to paint a picture of what is most important in their service provider selection process. Then, respondents evaluate service provider performance along the same dimensions. Using the selection driver data and performance ratings in tandem provides an opportunity for readers to gain a deep understanding of the Phase I outsourcing process and its players. "Similar to how one might read automobile reviews written by other drivers before buying a car, assessing how well a CRO has performed for recent users can help outsourcing decision-makers choose an appropriate Phase I CRO," states Olson. "The performance of a couple of Phase I CROs stands out. Celerion receives high marks for its performance in the Organization Factors category while SGS Life Sciences is noted for its performance in Staff Characteristics." High performers in Budget Factors, Delivery Factors, and Timelines Management categories are available in the full report. In addition to service provider selection drivers and performance ratings, this report offers insights into the use of preferred providers, cost perceptions/experience, and loyalty metrics, among other areas. For more information on ISR's CRO Quality Benchmarking - Phase I Service Providers (9th Edition) report, please visit ISR's report page here. Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's Web site at www.ISRreports.com, email [email protected], or follow ISR on Twitter @ISRreports.


With over 27 years' experience, Reza Vahabzadeh has a strong track record in the Consumer sector, having been involved in numerous transactions across the food, beverage, restaurant, and health/personal care industries, for clients including B&G Foods, Henkel, Hostess Brands and Pinnacle Foods. Prior to joining Rothschild, Mr. Vahabzadeh was a Senior Advisor to the Global Consumer Practice at Perella Weinberg Partners in New York, after spending 13 years at Lehman/Barclays as their High Yield Research Analyst covering the Consumer Products sector. He achieved Institutional Investor's #1 ranking in the space for 12 consecutive years. Mr. Vahabzadeh started his career at Bank of America in Los Angeles, and also worked at Transamerica Investment Management, Credit Suisse and Lehman Brothers. He holds a B.S. in Finance and Accounting, Magna Cum Laude from Boston College and an MBA in Finance from UCLA. Siddharth Hariharan joins Rothschild after 13 years at J.P. Morgan, where he was most recently the Executive Director and Head of Emerging Brands. While at J.P. Morgan, Mr. Hariharan developed a niche expertise in the Consumer sector, working on a number of consumer focused debt, equity and M&A transactions. He has advised clients including Fossil, Clorox, Planet Fitness, Nike and Under Armour, among others. Mr. Hariharan received his B.S. degree in Finance from Indiana University. Aashis Mehta comes to Rothschild from Lazard, where he was a member of their Healthcare Group. While at Lazard, Mr. Mehta served as the sole advisor on a number of healthcare M&A, IPO and restructuring transactions, and advised clients including Celerion, Copernicus Group and LabCorp, among others. Before joining Lazard in 2011, he spent seven years in the Healthcare Group at Credit Suisse and three years at Citigroup. Mr. Mehta holds an undergraduate degree from The Wharton School at the University of Pennsylvania. Timothy Hotchandani comes to Rothschild after spending the last seven years at Deutsche Bank, where he was most recently a Managing Director in the firm's Healthcare Group. During his time at Deutsche Bank, Mr. Hotchandani advised on a variety of M&A, debt and equity transactions for clients including Life Technologies, Abbott, Bio-Techne, Danaher, Merck KGaA, Qiagen and Thermo Fisher, among others. Mr. Hotchandani has also worked at Lehman Brothers, Macquarie Capital and Thomas Weisel Partners. He is a member of the Chartered Financial Analyst Institute and holds a B.B.A. in finance and economics, with distinction and Beta Gamma Sigma, from the University of Wisconsin-Madison. "I am excited to expand the depth and breadth of our coverage of the consumer retail landscape with such talented partners as Reza and Sid. Over the past 3 years, our North American franchise has experienced tremendous growth as clients have come to appreciate the differentiated advice and insights that we bring along with the uniquely coordinated reach of our global platform," said Peter "P.J." Moses, Managing Director at Rothschild Global Advisory, who leads the Consumer team in North America. "Jimmy and I look forward to working with all of our new colleagues to continue to grow our business in this market." This news follows the recent announcement that Chris Gaertner has joined Rothschild Global Advisory as the Global Head of Technology, along with Walid Khiari, who joins the firm as a Managing Director on its Technology team. Mr. Gaertner will lead the launch of the firm's new office in the San Francisco Bay Area. About Rothschild & Co Rothschild & Co is a family-controlled and independent business that has been at the centre of the world's financial markets for over 200 years. It is one of the world's largest independent financial advisory groups, employing approximately 3,300 people in over 40 countries around the world. Our integrated global network of trusted professionals provide in-depth market intelligence and effective long-term solutions for our clients in Global Advisory, Private Wealth, Asset Management, and Merchant Banking. Rothschild Global Advisory, a division of the Rothschild & Co Group, designs and executes strategic M&A and financing solutions. It combines the breadth of its advisory offering with a high volume of transactions to achieve a unique understanding and perspective into markets and participants worldwide. Rothschild Global Advisory provides impartial, expert advice to large and mid-sized corporations, private equity, families and entrepreneurs, and governments through an unrivalled network of 900 industry and financing specialists in over 40 countries worldwide. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/rothschild--co-adds-four-managing-directors-to-consumer-and-healthcare-teams-in-the-us-300462549.html


LINCOLN, Neb.--(BUSINESS WIRE)--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.” 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.


Islam R.,Celerion
Bioanalysis | Year: 2014

Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and purity to an innovator-approved product. While regulatory frameworks have been established for the approval of biosimilars in several countries, there is not an established guidance for bioanalytical testing of biosimilars. Although there are regulatory guidances and White Papers on testing requirements for biologics in general, there is a need to address the bioanalytical challenges and solutions that apply specifically to the analysis of biosimilars in biological samples. This paper will focus on components of the PK and immunogenicity assays that are critical to biosimilar drug development. © 2014 Future Science Ltd.


The purpose of this article is to articulate the fundamental issues of archiving electronic GLP data in a CRO environment. CROs struggle to address the absolute requirement of archiving GLP studies electronically. The difficulty of adhering to this is partly due to the wide variety of systems and types of electronic data. Often the end solution to this complicated issue is printing the data at the end of the study and in turn archiving the paper data, foregoing or ignoring the fact that scientific decisions were made while reviewing electronic data. Paper data and electronic data can be different. For example, chromatographic resolution or being able to focus in on detailed integration of chromatograms can significantly change the perspective of the data. While the core goal of archiving according to GLP principles are met, the reality is much different. Businesses purchasing CRO capabilities and regulatory agencies have been quite clear that when it comes to auditing the data that the electronic record is the preferred and often required source of the information for auditing and review purposes. The fact is that paper data do not always provide the flexibility, sensitivity and complete data context that an electronic record can provide. The ability to adhere to compliance standards due to the electronic data cannot be undervalued and by printing the data after all the acquisition, decisions, scientific judgments and review, do a complete disservice to the multidimensional (such as colors for deactivated or changed data, audit trails, 'zooming-in functionality', direct data links and snapshots) data in an electronic system. © 2011 Future Science Ltd.


Jamieson B.D.,Cempra | Ciric S.,Celerion | Fernandes P.,Cempra
Antimicrobial Agents and Chemotherapy | Year: 2015

Solithromycin, a new macrolide and the first fluoroketolide, is in late-stage clinical development and, like older macrolides, is primarily metabolized and excreted through liver-dependent mechanisms. This study evaluated the safety and pharmacokinetics of solithromycin in patients with chronic liver disease. This open-label, multiple-dose study in subjects with hepatic impairment and in healthy control subjects (matched for age, weight, and sex) enrolled 8 Child-Pugh class A (mild), 8 class B (moderate), and 8 class C (severe) patients and 9 healthy controls. Subjects (n = 33) received one 800-mg dose on day 1 followed by once-daily doses of 400 mg on days 2 through 5. The most commonly reported adverse events were mild diarrhea and mild headache, and no significant differences were noted between hepatically impaired subjects and healthy controls. The pharmacokinetics of plasma solithromycin in subjects with mild and moderate impairment was similar to that in control subjects. In subjects with severe impairment, total exposure to solithromycin at steady state (area under the plasma concentration-time curve [AUC0-tau]) was decreased compared to that in control subjects, which may have been related to the higher body mass index of individuals in this group. No greater accumulation was noted in any hepatically impaired cohort on day 5 compared to that in control subjects. No decrease in dosage is therefore needed when administering solithromycin to patients with mild, moderate, or severe hepatic impairment. Solithromycin was well tolerated in this patient population, and no significant differences in safety, compared to healthy controls, were noted. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


News Article | November 17, 2016
Site: www.prnewswire.com

LINCOLN, Neb., Nov. 17, 2016 /PRNewswire/ -- Celerion is pleased to announce a key technology addition to its early clinical development capabilities, Celexus®. Celexus® offers clients a first look at their early clinical research data in real-time, as it is collected in the clinics...


News Article | February 22, 2017
Site: www.businesswire.com

LINCOLN, Neb.--(BUSINESS WIRE)--Celerion continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined the company as Chief Medical Officer. Dr. Hoffman will have responsibility for leading the global medical staff and providing medical oversight and expertise to support early clinical research studies. Dr. Hoffman joins Celerion from Patient iP where he served as Chief Medical Officer, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Prior to joining Patient iP, he held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, Dr. Hoffman held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs. Dr. Hoffman brings over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He is experienced in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams. “We are pleased to have Marc join our executive leadership team during this exciting period of growth in our company,” said Susan Thornton PhD, President and CEO. “His depth of experience in managing all aspects of global drug development in multiple therapeutic areas will not only make him a valuable asset for our organization but also for our clients.” 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.


News Article | October 27, 2016
Site: globenewswire.com

FORT LAUDERDALE, Fla., Oct. 27, 2016 (GLOBE NEWSWIRE) -- OmniComm Systems, Inc. (OmniComm) (OTCQX:OMCM), a global leading provider of clinical data management technology, recognizes excellence in innovation at OmniComm’s 6th annual Innovation Forum customer summit.  Attendance increased more than 20% year-over-year, with participation from 42 life science companies and partners.  Attendees heard from over 19 different OmniComm customer and partner speakers, each of whom achieved significant gains in clinical trial productivity, clinic automation, clinical data quality, operational efficiency and compliance using OmniComm’s suite of eClinical products. “Every year I am impressed with the increasing diversity of our client base,” said Kuno van der Post, SVP of business development at OmniComm.  “We had representatives from pharmaceutical, biotechnology, medical device, academic research, and contract research (CRO) organizations, including delegates from four of the top five global CROs.  This broad spectrum of clients is a testament to our continued market growth.  We are on pace for a record sales year with almost half our business coming from new clients.  The scalability and flexibility of our technology and our specialization in EDC is a significant contributor to that growth.” Attendees also participated in product workshops prior to the start of the event.  These half-day workshops offered users free training and skills enhancement with TrialMaster® EDC and TrialOne®. “As the EDC specialist, we strive to be the pioneer in EDC technology, but the true pioneers are our customers.  Seeing the amazing value each and every customer has generated from our solutions is a moment of pride and fulfillment for our entire team,” said Cornelis Wit, CEO of OmniComm.  “The success of this conference is the result of the open sharing of customer experiences, successes and networking.  Maybe more importantly, the true measure of the user group success is the relationships that were developed which will extend the benefits for all of our users throughout the year and into the future.” OmniComm’s commitment to its customers extends to honoring organizations that share the passion for progress, creativity, collaboration, and advancement in life sciences.  The Excellence in Innovation Award recognizes life sciences organizations that have designed and implemented significant innovation using OmniComm’s technology and services, resulting in improved organizational operational efficiencies, best practices and business outcomes specifically for: This year’s Excellence in Innovation Award recipients are Celerion, TFS and WCCT Global. About OmniComm Systems, Inc. OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance.  OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 5,000 clinical trials. For more information, visit www.omnicomm.com. Trademarks OmniComm, TrialMaster, TrialOne and Promasys are registered trademarks of OmniComm Systems, Inc. Other names may be trademarks of their respective owners.

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