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Celerion achieves major milestone of successfully analyzing over 25,000 platelet aggregation samples.

Celerion’s unmatched experience in platelet aggregation benefits clients by producing higher quality data, reduced timelines and lower costs.

(Lincoln, NE; Jun 21, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces it has achieved a major milestone of generating over 25,000 platelet aggregation sample results. These samples were collected from over 1000 participants dosed in more than 20 studies. Platelet function assays are inherently variable, so this level of experience is critical to produce reliable and accurate platelet aggregation results.

The FDA public health advisory, released in 2009, described the potential for reduced anti-blood clotting activity due to drug-drug interactions. This has led to an increased need for platelet aggregation studies to better evaluate the impact of drug-drug interactions on platelet function.

To meet this industry need and client demand, Celerion made significant investments to implement intensive staff training and added cutting edge technology. The fully trained staff, in combination with state-of-the-art analyzers has produced unparalleled precision. Equally important, by deploying this technology, Celerion has been able to increase cohort size on studies requiring platelet aggregation, from eight to 40 participants, creating efficiency in the conduct of these studies.

“Reaching this milestone is a testament to Celerion’s ability to respond to the evolving needs of early clinical research,” said Phil Bach, Vice President, Global Clinical Research. “Our experience has already benefited many clients in producing high quality data efficiently, to help them achieve their goal of getting products to market sooner.”

About Celerion
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds, Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development 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. For more information, visit www.celerion.com.

Celerion announces highly automated ECG Analysis enabling data delivery within 37 days from first patient dosed

Clients benefit from faster access to higher quality data and cost savings in their drug development programs.

(Lincoln, NE; Jun 20, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the successful completion of a 133 participant parallel design Thorough QT (TQT) study using the innovative Celerion Hybrid Phase I/ ECG Core Lab. The efficiencies developed in both clinical conduct and ECG analysis enabled Celerion to quickly collect and analyze over 9,000 ECG recordings, delivering the final dataset containing all data for the study to the sponsor company within 37 days from first patient dosed.

“This study continues to demonstrate Celerion’s commitment to implement innovative technologies that enable fast access to high quality data and ultimately save costs for clients,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “The Hybrid Phase I/ ECG Core Lab, when used for the execution of TQT studies and ECG assessment in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, enables our clients to deliver on their goal of getting products to market faster.”

The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion’s global Phase I clinical network that minimizes cardiologist review time and expense. This novel approach was built upon the knowledge gained from conducting more than 100 studies with intensive ECG monitoring including 36 TQT studies and fully integrates both the core lab and clinic functions. Extensive experience in early cardiac safety services allowed Celerion to carefully define where efficiencies could be realized when developing the Hybrid Phase I/ ECG Core Lab. Integration of the core lab and clinic minimizes the inefficiencies associated with separate management of the two functions.

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development 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. For more information, visit www.celerion.com.

Celerion receives ANVISA certification

Brazilian Regulatory Agency Approves Celerion Facilities in both North America and Europe to Conduct Clinical Research and Bioanalytical Services.

(Lincoln, NE; Jun 9, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, and its clinical research and bioanalytical services operations in Lincoln, Nebraska USA, have been certified by the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária – ANVISA).

ANVISA provides regulatory approval for drugs and other products seeking to enter the large and growing Brazilian market. ANVISA-certified service providers are uniquely qualified to help clients clear a key hurdle to access one of the fastest-growing major pharmaceutical markets in the world.

“The approval of ANVISA continues to demonstrate the high quality work done at Celerion.” said Susan Thornton, President and CEO. “By earning ANVISA certification to conduct early clinical studies and bioanalytical research for compounds destined for Brazil, Celerion is now able to better serve our clients’ growing needs in this high–growth, emerging market.”

In addition to ANVISA certification, Celerion’s Belfast, facility has also been certified by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The facility has received both Standard and Supplementary Accreditation from the MHRA, which certifies that the general standards for study participant safety and access to emergency medical response have been met. The MHRA accreditation attests to Celerion’s commitment to participant safety.

About Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. 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, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

Celerion Awarded Prestigious LEED® Green Building Certification

Celerion is the first research clinic in the U.S. to be awarded LEED® Silver certification.

(Lincoln, NE; May 26, 2011) – Celerion, a premier provider of innovative early stage drug development solutions, announced today that it has been awarded LEED® Silver established by the U.S. Green Building Council and verified by the Green Building Certification Institute (GBCI). LEED is the nation’s preeminent program for the design, construction and operation of high performance green buildings.

Celerion is the leading provider of comprehensive early stage clinical research and bioanalytical services to the drug development community. The facility in Phoenix, Arizona is a state-of-the-art 300 bed, 104,947sf, early clinical research facility and is the Center of Excellence for early cardiac studies. Celerion was the first CRO to launch the Hybrid Phase I/ECG Core lab, which was developed in Phoenix, and launched to our global network of clinics.

Celerion achieved certification under the LEED for Existing Buildings: Operation & Maintenance rating system for energy use, lighting, water and material use, as well as incorporating a variety of other sustainable strategies to make it the first research clinic of its type in the country to attain such an honor. By using less energy and water, LEED certified buildings save money for families, businesses and taxpayers; reduce greenhouse gas emissions; and contribute to a healthier environment for residents, workers and the larger community.

“We are very pleased to receive this certification,” said Susan Thornton, President and CEO of Celerion. “The upgrades made to our state-of-the-art facility in the Phoenix metropolitan area serve as an example of Celerion’s commitment to creating a healthy work environment, reducing our environment footprint and delivering more efficiency for clients. We applaud the leadership and hard work of our project team and the willingness of third party vendors to volunteer their time to achieving these important goals.” A primary focus for the team was to aggressively pursue no/low cost alternatives to successfully meet the certification requirements.

“Celerion’s LEED certification demonstrates tremendous green building leadership,” said Rick Fedrizzi, President, CEO & Founding Chair, U.S. Green Building Council. “The urgency of USGBC’s mission has challenged the industry to move faster and reach further than ever before, and Celerion serves as a prime example with just how much we can accomplish.” LEED certification of Celerion was based on a number of green sustainable practices, and design & construction features that positively impact the project itself and the broader community. Some of these practices and features include:

• Metering faucets, and ultra-low flow shower heads and aerators that contributed to a 25% reduction in water use
• Collection of 73% of the precipitation falling on the entire site and grounds to reuse for irrigation or evapotranspirates
• Water efficient landscaping by using a micro-irrigation system and native, adaptive plants
• 39% participation in the Alternative Transportation/Trip Reduction Program to offset conventional automobile commuting
• 80% reuse and recycling of consumable waste and 100% reuse, recycling of durable goods
• Building systems perform 20% better than the national average for optimizing energy efficiency

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, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

The U.S. Green Building Council

The Washington, D.C. based U.S. Green Building Council is committed to a prosperous and sustainable future for our nation through cost-efficient and energy-saving green buildings.

With a community comprising 80 local affiliates, more than 18,000 member companies and organizations, and more than 155,000 LEED professional Credential holders, USGBC is the driving force of an industry that is projected to contribute $554 billion to the U.S. gross domestic product from 2009-2013. USGBC leads an unlikely diverse constituency of builders and environmentalists, corporations and nonprofit organizations, elected officials and concerned citizens, and teachers and students.

Buildings in the United States are responsible for 39% of CO2 emissions, 40% of energy consumption, 13% water consumption and 15% of GDP per year, making green building a source of significant economic and environmental opportunity. Greater building efficiency can meet 85% of future U.S. demand for energy, and a national commitment to green building has the potential to generate 2.5 million American jobs.

LEED

THE U.S. Green Building Council’s LEED green building certification system is the foremost program for the design, construction and operation of green buildings. Over 32,000 projects are currently participating in the commercial and institutional LEED rating systems, comprising over 9.5 billion square feet of construction space in all 50 states and 114 countries. For more information, visit www.usgbc.org.

Celerion recognized as member of the UK Respiratory Therapeutic Capability Cluster

The membership of Celerion’s Belfast facility within the UK Respiratory Therapeutic Capability Cluster enables faster access to patient populations, specialists and techniques in Phase I & IIa studies. Clients benefit from faster access to data that expedites decision making and speeds up the path to clinical Proof-of-Concept.

(Lincoln, NE; Mar 28, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the membership of the Belfast facility within the UK Respiratory Therapeutic Capability Cluster. Celerion will work with key decision makers and thought leaders in the UK to develop and execute Phase I and IIa studies with targeted patient populations.

The UK Respiratory Therapeutic Capability Cluster is a unique cooperative of internationally leading clinicians and scientists whose aim is to improve the speed of developing innovative therapies for respiratory diseases by working in collaboration with research groups of the pharmaceutical industry.

The collaboration with the UK Respiratory Therapeutic Capability Cluster provides access to patients suffering from asthma, COPD, cystic fibrosis, bronchiectasis and interstitial lung disease. Celerion has access to laboratory capabilities (flow cytometry, flow cytometric cell sorting, microbiology, 16S, deep sequencing, MLST, transcriptomics) as well as lung imaging techniques (CT acquisition of images, dedicated MRI time, advanced CT analysis capabilities and MRI acquisition of images).

“The membership of Celerion into the UK Respiratory Therapeutic Capability Cluster will provide our clients a one stop solution that provides access to targeted patient populations. Celerion provides a full service approach for clinical studies from protocol development through to final report,” said Phil Bach, Vice President of Clinical Research at Celerion. “We have seen an increasing demand for conducting Phase I studies in patients with access to more specialized techniques. This collaboration allows Celerion to address this need and assist clients to gain insight to data earlier in drug development programs.”

All the centres in the UK Respiratory Therapeutic Capability Cluster are recognised for their excellence in basic and translational research in respiratory medicine. Celerion is delighted to be part of this distinguished team of talented individuals, with a proven track-record in helping industry better to understand airways disease and facilitate drug discovery.

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, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

Celerion adds USP <797>-compliant Clean Room, enabling efficient execution of microtracer and microdosing studies

The addition of the USP <797> Clean Room to Celerion’s Phase I core capabilities, enables sterile extemporaneous compounding in-house for microtracer studies. Clients benefit by accessing quality data earlier in drug development process.

(Lincoln, NE; Mar 2, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the completion of a Clean Room and pharmacist certification to comply with USP <797> 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 clients a one-stop option thereby saving time and money.

A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> 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 addition of the USP <797> Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier” said Phil Bach, Vice President of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, 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.”

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.

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, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. For more information, visit www.celerion.com.

Celerion and BryanLGH Health System Form Alliance to Provide Dedicated Hospital Beds for Phase I Studies

(Lincoln, NE; Dec 9, 2010) –Celerion, the premier provider of innovative early stage clinical research solutions, and BryanLGH Health System, a locally owned, non-profit healthcare organization, announce an alliance to provide a dedicated wing at BryanLGH Medical Center West in Lincoln, Nebraska for early clinical studies including Phase I and First-In-Human.

This exclusive alliance will provide pharmaceutical, and biotechnology companies the opportunity to place clinical studies in a hospital environment, thus increasing safety for study volunteers and improving access to hospital procedures and techniques for studies placed at Celerion’s Lincoln clinical facility. Celerion will have access to 24 in-patient beds, in the newly launched Celerion-BryanLGH Clinical Research Unit. Celerion will leverage over forty years experience conducting clinical studies and will incorporate the same staff, global standard operating procedures and institutional review board, ensuring consistency across all studies executed at our sites.

“Improving safety for participants in clinical studies, while getting drugs to market faster, is critical to pharmaceutical companies”, said Philip Bach, Vice President, Clinical Research at Celerion. “This alliance will allow Celerion to conduct studies in a hospital environment, providing round-the-clock emergency care. Celerion will also strengthen their capabilities with access to state-of-the-art hospital techniques and equipment, such as chest X-rays, PET scans, and MRIs, for studies executed at our clinical facility in Lincoln, Nebraska.”

“We are very pleased to collaborate with Celerion on this venture. Celerion’s staff is among the best in the industry, with extensive experience and expertise – going back to its founding in Lincoln in 1933 as Harris Labs”, said Kimberly A. Russel, President and CEO at BryanLGH. “This alliance affirms a major commitment by BryanLGH Health System to clinical research and is a natural extension of our medical expertise. We will safely help get drugs to market faster, which will benefit everybody.”

BryanLGH is one of only 74 hospitals in the United States to have received both the 2010 Distinguished Hospital Award for Clinical Excellence™ and the Patient Safety Excellent Award™ from HealthGrades®.

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.

The company offers 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, Celerion applies 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, visit www.celerion.com.

About BryanLGH

BryanLGH Health System includes BryanLGH Medical Center, Crete Area Medical Center, BryanLGH Heart Institute, BryanLGH Physician Network, LifePointe by BryanLGH and the BryanLGH Foundation.

BryanLGH Medical Center is a 664-bed, not for profit, locally owned, healthcare organization serving patients from throughout Nebraska, as well as parts of Kansas, Iowa, South Dakota and other states in the region. Premier services include cardiology, neuroscience, orthopedics, vascular, trauma and emergency centers, intensive care, women’s and children’s health, imaging, and mental health. BryanLGH College of Health Sciences offers graduate and undergraduate degrees through its School of Nursing, School of Health Professions and School of Nurse Anesthesia.

BryanLGH received the Gold Seal of Approval from the Joint Commission on Accreditation of Healthcare Organizations, which sets the highest standards for quality and safety in the delivery of health care.

For more information, visit www.bryanlgh.com.

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.