Author: Celerion

Celerion launches electronic laboratory notebook, achieving major milestone toward goal of 100% paperless laboratories.

Newly implemented electronic laboratory notebook enables faster access to data and real-time data integrity from ongoing quality control throughout the bioanalytical workflow.

(Lincoln, NE; Nov 12, 2010) – Celerion, the premier provider of innovative early stage drug development solutions, announces implementation of the electronic laboratory notebook in our global bioanalytical network. Celerion designed and implemented Labnotes, a commercially available electronic laboratory notebook system to standardize bioanalytical processes and improve documentation consistency for all studies.

Clients benefit from faster access to data and improved information quality due to centralized data repositories. Real time data integrity eliminates manual calculations and sources of potential error.

The electronic laboratory notebook has built-in calculations for critical aspects of the bioanalytical workflow, standardizing everything from reference standards, to instrument and pipette calibration. The system increases consistency and significantly reduces sources of manual error. The electronic laboratory notebook is validated to OECD GLP and FDA 21 CFR Part 11 computerized system regulatory requirements.

“The implementation of the electronic laboratory notebook continues to demonstrate Celerion’s commitment to leveraging innovative technologies to provide our clients faster access to higher quality data,” said Susan Thornton, President and CEO of Celerion. “This system standardizes bioanalytical processes, improves documentation consistency for all studies, and supports the generation of data in a validated electronic environment across our global facilities.”

Celerion collaborated with Laboratory Data Solutions Ltd on their Labnotes electronic laboratory notebook product. “We are delighted to have worked with Celerion on implementing the Labnotes solution” said Jeremy Cook, Director of Laboratory Data Solutions. “The team at Celerion has invested significant time in ensuring the system is completely integrated into the bioanalytical workflow, clearly demonstrating they are leaders in this field.”

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. Formed through the acquisition of the early stage development operations of MDS Pharma Services, Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (Phases 0, I and IIa), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, please visit www.celerion.com.

About Labnotes

Labnotes is a commercially available solution that can be configured to comply with the differing data recording requirements of most laboratory environments. Labnotes has been implemented in a number of bioanalytical laboratories and has demonstrated significant improvements in quality and productivity. For more information, please visit www.labnotes.com.

Celerion launches new Hybrid ECG Core Lab for Phase I clinics

Hybrid ECG Core lab provides clients faster access to data, cost savings and higher quality of data

(Lincoln, NE; Jun 2, 2010) – Celerion, the premier provider of innovative early stage clinical research solutions, announces the launch of a new Hybrid Phase I/ ECG Core lab. The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion’s global Phase I clinical network. Celerion’s highly automated approach employs cutting-edge technology to perform automated measurement of ECG recordings, thereby minimizing cardiologist review and providing clients with faster access to data. The system also effectively identifies the small number of ECG recordings that will still require cardiologist review. This reduction in cardiologist involvement, combined with much smaller overhead compared to traditional ECG Core labs supporting global clinical trials, allows Celerion to offer significant cost and time savings to clients.

The Hybrid Phase I/ ECG Core lab was developed in collaboration with AMPS-LLC (Analyzing Medical Parameters for Solutions), and Global Instrumentation, LLC (GI). AMPS-LLC is a world leader in high quality ECG analysis software utilized by many ECG Core labs. Global Instrumentation is a pioneer in the development of Bluetooth-enabled Holter monitors. Celerion is proud to host the first installation of AMPS’ FAT-QT and TrialPerfect software platforms, in addition to being the first contract research organization (CRO) to deploy the Global Instrumentation technology for Phase I/ ECG trials.

“The introduction of the Hybrid Phase I/ ECG Core lab clearly establishes Celerion as the world leader in innovative early cardiac services,” said Susan Thornton, CEO of Celerion. “By integrating the ECG functions within our clinic network, minimizing traditional ECG overhead and providing more automation, Celerion enables 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.”

Fabio Badilini, founder and chief scientist at AMPS-LLC stated, “We are delighted to be collaborating with Celerion. The suite of AMPS-LLC software provides considerable advantage by ensuring optimal extraction of ECG recordings from Holters, providing accurate interval measurements in the vast majority of ECGs and identifying those recordings that may require a cardiologist’s review.”

According to Jim DeMaso, President of Global Instrumentation, “The GI M12R recorder and M12A Enterprise software provide state-of-the-art Holter functions with full standard 12-lead ECG functionality in a centralized data management system designed for the requirements of clinical trials. We are pleased to be part of the Celerion/AMPS collaboration, which has led to the advancement in performing clinical trials using this new semi-automated process.”

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. It was formed through the acquisition of the early stage development operations and development and regulatory services consultancy of MDS Pharma Services. They offer a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. From facilities strategically located around the world, they apply advanced scientific and technological expertise to clinical research (Phases 0, I and IIa), bioanalytical services (discovery through late stage), clinical pharmacology sciences and drug development services. For more information, please visit our website at www.celerion.com.

About AMPS

AMPS-LLC, based in New York, New York, is a leading-edge software company providing software solutions used specifically by clinical research organizations (CROs) and pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. They are well known for the support given to the FDA for the establishment of the HL7 XML ECG standard and for providing FDA Officials with the famous AMPS XMLFDA Viewer tool. The company’s website is www.amps-llc.com.

About Global Instrumentation, LLC

Global Instrumentation is a privately owned company with headquarters located in Manlius, New York, and with operations in India and Florida. Global Instrumentation develops, manufactures and distributes its ECG devices worldwide and through OEM relationships. The company also provides design, manufacturing, and product support services to companies within the medical industries. The three principals of Global Instrumentation have over 90 years combined experience developing medical products. Global Instrumentation is an FDA-registered manufacturer with certification for ISO13485 and CMDCAS. Global Instrumentation’s current products include a complete line of Holter products consisting of ECG recorders and Holter Analysis systems designed for stand-alone usage as well as enterprise web based usage. The company also has specific solutions for web-based data warehousing to support any clinical trial, scanning service or distributed processing centers. More information can be found at www.gimedical.com.

Celerion acquires early stage clinical research operations from MDS Pharma Services

(Lincoln, NE, Mar 29, 2010) – Celerion, a privately owned contract research organization (CRO), has completed the acquisition of the development and regulatory services consultancy and early stage development operations of MDS Pharma Services. The acquired assets include five clinical research facilities and two bioanalytical laboratories located in Lincoln, Nebraska; Neptune, New Jersey; Phoenix, Arizona; Zurich, Switzerland; and Belfast, Northern Ireland, as well as operations in Richmond, Virginia and Quebec, Canada. With over 700 beds worldwide, Celerion is an industry leader in the conduct of early clinical research, including first-in-man to proof-of-concept clinical studies, clinical pharmacology, bioequivalence trials, bioanalysis, and cardiac safety services.

Celerion is derived from the Latin celeritas meaning swiftness and speed. This word reflects one of Celerion’s founding principles: to deliver services that enable clients to get their products to market faster. It also underlies another key goal of the business: to assist clients in reaching informed go/no-go decisions on compounds in development as early as possible.

Life sciences and CRO industry veteran Susan Thornton, Ph.D., is Chief Executive Officer of Celerion. “I’m energized by the prospect of taking this great business to the next level of market leadership,” she said. “Its combination of experienced people, scientific excellence, and state-of-the-art facilities constitutes a strong foundation for future growth. We look forward to continuing to provide our pharmaceutical, biotechnology and generic clients with leading early stage clinical research services. Like the company I am leading, my roots are in MDS Pharma Services.”

Before her appointment as CEO of Celerion, Dr. Thornton was CEO and Managing Partner for BioVerum Partners, a healthcare advisory services firm that assists clients in maximizing the value of their life sciences businesses. In addition to over a decade of CRO industry experience, she has held various drug development roles at GlaxoSmithKline and Merck. Dr. Thornton earned a Ph.D. in molecular biology from the University of Pennsylvania and a M.S. in microbiology and B.S. in psychology from Pennsylvania State University. Her appointment sets the precedent for the new leadership team at Celerion – individuals with extensive industry experience and knowledge, strongly positioning the company to address a broad range of drug development challenges.

About Celerion

Celerion is a premier provider of early stage clinical research services. The company offers a full range of resources to meet the needs of the pharmaceutical, biotechnology and generic industries. From facilities strategically located around the world, Celerion applies advanced scientific and technological expertise throughout the early phases of drug development, including regulatory services, first-in-man to proof-of-concept clinical studies, bioanalysis and consultancy services.