News
M2S doubles clinical trial image management business in 2009
West Lebanon, NH – February 1, 2010 – M2S Inc., a global provider of image management services for biopharmaceutical and medical device clinical trials announced that the company doubled its clinical trials business from December 2008 to December 2009. At the close of 2009, M2S was managing trials across multiple therapeutic areas, including vascular device, oncology, musculoskeletal and osteoporosis. The trials ranged from Phase I to Phase III for the biopharmaceutical industry and from first-in-man to pivotal within the device trials.
The increase in clinical trials image management business is attributed to M2S’ focus on increasing operational efficiency, delivering clinical quality and reducing total costs for the sponsors. With the ongoing development of its clinical trial technology tools and its Lean Six Sigma continuous improvement principles, the company strives to meet and exceed the expectations of customers while continuously increasing internal process efficiency.
At the forefront of the expanding clinical trial business is M2S’ top-notch technology platform. The company has made large advancements within its e-clinical technologies, providing more speed and efficiency to allow customers to view results faster. Building on its proprietary image transfer technology, the DICOM ArmorCar® (DAC®), M2S has recently expanded its image transfer capabilities, adding two web-based applications for customers to allow images to be sent electronically for processing and review, meeting a recognized need in the industry. M2S has also expanded its e-clinical technology capabilities with further enhancements to its web-based, real-time data management and reporting systems. To learn more about the technology advancements M2S made in 2009, visit http://www.m2s.com/2009-technology.
About M2S
M2S offers medical image data management services across the healthcare continuum, and in 2008 the company acquired the DXA Resource Group (DRG) to further expand it scope of services. M2S clinical trial image management services include protocol development, electronic image collection, independent review, archiving and real-time web-based data management. Its clinical data registries provide long-term evaluation of treatment outcomes, benefits and cost. Over that past 10 years, M2S has managed, under protocol, over 150 million images from around the globe in all DICOM modalities. For more information, visit www.m2s.com.
M2S Announces Sum of Yearly Technological Updates and Releases
January 18, 2010 – M2S, Inc., a leading provider of medical data and image management services for the healthcare, pharmaceutical, biotech, and medical device industries announces a total of 108 technological updates and releases during the 2009 year relating to both its proprietary and licensed technology systems, which are dedicated to providing solutions for clinical trials, clinical data management and advanced image analysis. Of the advancements, seventy six were specific to the clinical trial services systems and six related to Clinical Data Pathways, M2S’ clinical data management and quality improvement solution. The numerous updates and releases to the company’s flexible technology platform emphasize M2S’ focus on increasing operational efficiency, delivering clinical quality and reducing total costs to meet customer needs.
Clinical Data Pathways powered by M2S was initially released in the beginning of 2009 and has since received five updates to increase usability, add reporting functions, and include new editing features. A new feature released in early 2010 included a Peripheral Vascular Intervention procedural data entry form. Upcoming releases include fully executed electronic medical record (EMR) integration capabilities, usability features and more ad-hoc reporting functions.
Within the realm of M2S’ Clinical Trial image management services, the company made large expansions within its eclinical technologies, providing more speed and efficiency which allows customers to view results faster. Building on its proprietary image transfer technology, the DICOM ArmorCar® (DAC®), M2S has been working to add two web-based applications for customers to send images to the company – the Web DAC and the secure FTP DAC. This full suite of image transfer solutions, to be completed in early 2010, gives M2S the ability to meet the unique needs of each trial.
Other technologies released to enhance overall eclinical capabilities and processes included iCTMS, M2S’ Imaging Clinical Trials Management System which added reporting functions, as well as general and usability features. Also, customized data transfer forms and updates to internal workflow systems were completed in 2009.
M2S looks forward to continuous upgrades of product offerings in 2010 to ensure secure and efficient processes for the services provided to its customers. Coming soon for clinical trial services is a new release to iCTMS that will consist of, among other new features, a dashboard containing critical information of interest to clinical trial stakeholders and a query management database is also on the list.
Contact the sales team at M2S for more information or to receive a demo of its services and technologies.
M2S announces listing as a Patient Safety Organization by the Agency of Healthcare Research and Quality
December 16, 2009 - M2S, Inc., a leading provider of clinical data and image management services, today announced that its component organization, Vascular Study Group Patient Safety Organization, LLC (VSG PSO), has been approved as a Patient Safety Organization (PSO) by the Agency of Healthcare Research and Quality, a division of the Department of Health and Human Services. Listing as a PSO offers providers a means to pool outcomes data for quality improvement purposes in a federally protected environment shielded from discovery in disciplinary proceedings.
M2S provides physicians, hospitals and other healthcare providers with the ability to improve practice standards through use of its Clinical Data Pathways platform. Pathways is a secure, web-based clinical data management solution that provides real-time access to risk-adjusted benchmarked reports and facilitates local, regional and national data collaboration, while providing the customer with complete control of their data.
“Listing as a PSO encourages providers to pool and compare outcomes data to determine treatment best practices without fear of litigation. Moreover, submitting outcomes data to a PSO does not require individual patient consent or prior IRB approval, making this a simple way for providers to assess and improve the quality of care they provide to their patients,” stated M2S CEO, Wes Chapman. For publishing and research purposes, M2S has put in place best-in-class security and privacy policies to reduce obstacles traditionally associated with attaining IRB approval and patient consent.
M2S developed its Clinical Data Pathways system through partnering with the Vascular Study Group of New England (VSGNE) to advance its vascular quality improvement registry. The VSGNE quality improvement registry, formed in 2002, has prospectively collected data on more than 12,000 patients undergoing carotid endarterectomy, carotid stenting, lower extremity arterial bypass and open and endovascular repair of abdominal aortic aneurysms. It is the vision of both the VSGNE and M2S that the vascular quality improvement registry model will be replicated in other regions of the United States, facilitating widespread benchmarking and quality initiatives to improve patient outcomes.
About M2S, Inc.
M2S offers medical data and image management services across the healthcare continuum based on best-in-class technology and continuous quality improvement processes, including clinical data management solutions, clinical trials and advanced radiographic image analysis. All M2S services focus on increasing operational efficiency, reducing total cost and maintaining or enhancing clinical quality. M2S is the leading provider of AAA and TAA Treatment Planning using its Preview® Software/Services and its PEMS® (Patient Endovascular Management Services) registry for the vascular surgery field. For more information, visit www.m2s.com.
Vascular Study Group of New England selects Clinical Data Pathways, powered by M2S as quality improvement registry provider
West Lebanon, NH, October 20, 2009 – M2S, Inc. and the Vascular Study Group of New England (VSGNE) have partnered to advance the VSGNE quality improvement registry. Clinical Data Pathways, powered by M2S, is a secure, web-based clinical data management solution that offers physicians, hospitals, medical centers and clinical researchers the power to assess outcomes, enhance clinical quality and improve practice standards while providing the customer with complete control of their data.
The VSGNE quality improvement registry, formed in 2002, has prospectively collected data on more than 12,000 patients undergoing carotid endarterectomy, carotid stenting, lower extremity arterial bypass and open and endovascular repair of abdominal aortic aneurysms. There are currently twelve hospital members of the VSGNE from MA, ME, NH and VT. By studying their outcomes, the group has been able to identify best processes of care and better patient selection algorithms to improve patient outcomes.
It is the vision of both the VSGNE and M2S that the vascular quality improvement registry model will be replicated in other regions of the United States, facilitating widespread benchmarking and quality initiatives to improve patient outcomes. The collection and exchange of anonymous aggregate data across multiple participants in the registry fosters continuous improvement in the quality, safety, effectiveness and cost of caring for patients.
“M2S is excited to be part of the VSGNE’s mission to improve quality and enhance clinical outcomes within their region and across the country. As a provider of leading medical imaging tools for vascular surgeons, our company embraces technological advances and are certain that our data management solution will meet the growing needs of healthcare organizations,” M2S CEO Wes Chapman commented.
“We selected M2S as our vendor because of its experience with vascular image management registries, its status as a six sigma company with established protocols for data integrity and its powerful database platform using Oracle Clinical,” Jack Cronenwett, M.D. from Dartmouth-Hitchcock Medical Center and Principal Investigator of the VSGNE, stated.
About M2S, Inc.
M2S offers medical data and image management services across the healthcare continuum based on best-in-class technology and continuous quality improvement processes, including clinical data management solutions, clinical trials and advanced radiographic image analysis. With over 10 years of experience, M2S has created Clinical Data Pathways to give health care providers greater ownership and control of patient data, provide real-time access to risk-adjusted benchmarked reports and facilitate local, regional and national data collaboration. All M2S services focus on increasing operational efficiency, reducing total cost and maintaining or enhancing clinical quality. For more information, visit www.m2s.com.
M2S, Inc. announces agreement with Pervasive Software to provide data integration for Clinical Data Pathways
September 29, 2009 - M2S, Inc., a leading provider of clinical data and image management services, today announced that it has entered an agreement with Pervasive Software (NASDAQ, PVSW), a global leader in data integration software, to improve the versatility and efficiency of its Clinical Data Pathways product. Through the agreement, Pervasive Software will provide M2S Clinical Data Pathways customers the ability to extract data directly from their existing electronic health records and import it into the Pathways database, allowing the customer to pool data within their institution, with peers and/or exporting to third parties/registries.
Clinical Data Pathways, powered by M2S, is a secure, web-based clinical data management solution that offers physicians, hospitals, medical centers and clinical researchers the power to assess outcomes, enhance clinical quality and improve practice standards while providing the customer with complete control of their data.
"Partnering with Pervasive expands our service offering for Clinical Data Pathways customers, allowing bidirectional integration, eliminating duplicate data entry and streamlining their patient documentation workflows,” said Wes Chapman, CEO of M2S.
“We are pleased to partner with M2S to help automate their processes and speed time to revenue,” stated Mike Hoskins, CTO and general manager of Data Integration Products at Pervasive. “Pervasive has a long history of providing the healthcare industry with robust, seamless interoperability solutions and it is great to see organizations like M2S find innovative ways to enable their customers’ success.”
About M2S, Inc.
M2S offers medical data and image management services across the healthcare continuum based on best-in-class technology and continuous quality improvement processes, including clinical data management solutions, clinical trials and advanced radiographic image analysis. With over 10 years of experience, M2S has created Clinical Data Pathways, to provide greater ownership and control of patient data to health care providers, facilitating local, regional and national data collaboration, as well as real-time access to risk-adjusted benchmarked reports. All M2S services focus on increasing operational efficiency, reducing total cost and maintaining or enhancing clinical quality. For more information, visit www.m2s.com.
About Pervasive Software
Pervasive helps companies get the most out of their data investments through embeddable data management, agile data integration software and by enabling revolutionary next-generation analytics. For more information on Pervasive Data Integration, visit www.pervasiveintegration.com.
M2S announces new Clinical Trial product, iMAS, for medical image collect and hold solution
West Lebanon, NH – July 29, 2009: M2S Inc., a global provider of image management services for biopharmaceutical and medical device clinical trials, today announced that it has launched a new product to collect and hold medical images in clinical trials, called iMAS (Image Management Archive System). iMAS is a cost-effective option for clinical trial sponsors to centralize the collection of the large imaging data sets frequently utilized in clinical trials, while giving them accessibility and secure storage, with minimal investment.
"Clinical trial sponsors are facing extraordinary cost pressures in the current economy,” said Wes Chapman, CEO of M2S. “With less time needed for setup, decreased trial complexity and reduced documentation requirements, an M2S iMAS trial is typically only 20% of the cost of a full clinical trial. This option gives trial sponsors the control and flexibility to adjust a trial and add a blinded radiological review at any point, while simultaneously containing costs."
While many clinical trials continue to incorporate imaging data for surrogate endpoints, it is not always clear whether or not image data review and submission will be necessary. However, potentially valuable and expensive imaging data can and probably should still be collected. Sponsors may want to consider using those images for a later submission, subsequent trials or for patient registries, and the risk, cost and effort of retrospectively collecting images can exceed that of prospective medical image collection. M2S will customize the iMAS product based on service levels needed for a particular clinical trial – including consultation, project management and query management. Real-time, web-based reports allow sponsors to see both the status of data gathered as well as access the data anytime, anywhere. Transparency and flexibility for the sponsor, as well as the ability to reduce a sponsor’s risk through proactive image management strategies, are the cornerstones of iMAS’ success.
About M2S, Inc.
M2S offers medical image data management services across the healthcare continuum based on best-in-class technology and continuous quality improvement processes. M2S clinical trial image management services include protocol development, electronic image collection, independent review, archive and real-time web-based data access. M2S clinical data registries provide long-term evaluation of treatment outcomes, benefits and cost. All services focus on increasing operational efficiency, reducing total cost and maintaining or enhancing clinical quality. For more information, visit www.m2s.com.
M2S announces agreement with AG Mednet
M2S announces agreement with AG Mednet to provide clinical trial sponsors with more options for efficient image transfer & collection
West Lebanon, NH - March 31, 2009: M2S Inc., a global provider of image management services for biopharmaceutical and medical device clinical trials, today announced that it had entered into an agreement with AG Mednet, a HIPAA and 21 CFR Part 11 compliant diagnostic imaging exchange network.
The agreement will allow M2S to offer clinical trial sponsors more options for efficient, cost-effective image collection and transfer.
"Our agreement with AG Mednet significantly expands our service offerings for clinical trials image management,” said Wes Chapman, CEO of M2S. “It enables us to provide image collection and transfer services based on the unique needs of each trial. In addition, the AG Mednet solution is a perfect complement to our DICOM Armor Car® (DAC) and other image transfer technologies.”
Chapman also noted that by offering expanded image collection and transfer options, M2S can help sponsors save both time and money. “In an era of immense cost pressures, M2S is proud to be the only imaging core lab able to offer rapid and high-quality imaging data through both hardware and software-based options while also providing measurable time and cost savings," he stated.
Abraham Gutman, President & CEO of AG Mednet added that his company is pleased to be working with M2S.
“The AG Mednet web-enabled network, together with its powerful workflow and de-identification capabilities, is rapidly becoming the standard software-based image delivery platform, and will provide M2S with a highly scalable solution to fit the needs of the most demanding global trials.” said Gutman.
Clinical trials are increasingly using medical imaging for inclusion criteria, secondary and surrogate endpoints and to serve as adjunctive safety assessment of drugs under development. Imaging provides a non-invasive method of obtaining information on a drug's effects in the body and can provide crucial information for making early "go/no-go" decisions, potentially saving millions of dollars in development costs. Collecting and managing large amounts of imaging data securely and rapidly can be challenging and often costly for trial sponsors, and the traditional method of image transfer via hard media and courier services is very time-intensive and error prone. Electronic data transfer of images drastically reduces the time involved, provides the opportunity for early discovery and resolution of queries, and therefore can provide significant cost savings in clinical trials.
M2S has been utilizing web-based methods for rapid and secure electronic image collection and transfer since 2002, with their proprietary network transfer device, the DICOM Armor Car (DAC®), which has an installed base of 287 sites worldwide. The AG Mednet network, in use at over 600 investigator sites globally, provides a web-enabled site interface allowing investigators to de-identify exams, fill electronic transmittal forms and submit the data directly to M2S trial repositories. Whether a trial is a Phase I using imaging for inclusion criteria, or a Phase III multi-center international study with multiple imaging modalities for surrogate endpoints, M2S has the technology and process combination to provide the best customized solution.
About M2S, Inc.
M2S is a full-service imaging CRO, providing high-quality, timely and cost-effective image data management services for clinical trial sponsors in the biopharmaceutical and medical device industries as well as patient registry databases. For the past 10 years, M2S has managed, under protocol, over 150 million images from around the globe in all major therapeutic areas and in all DICOM modalities. For more information, visit www.m2s.com.
About AG Mednet, Inc.
AG Mednet, Inc. is a global diagnostic imaging network. Pharmaceutical, biotech and medical device companies, core labs and clinical research organizations utilizing imaging technology as part of their trial protocol rely on AG Mednet's automated system to enable the secure electronic transfer of cases from hundreds of locations, enhancing site compliance while providing detailed reporting necessary to meet the most stringent regulatory requirements. Additional information about AG Mednet is available at www.agmednet.com.
M2S, Inc. Makes Contribution to American Vascular Association
West Lebanon, NH - February 11, 2009: M2S, Inc. a global provider of image management services for endovascular imaging and medical device clinical trials announced that it has made a contribution to the Open the Pathway campaign of the American Vascular Association (AVA). Open the Pathway is an initiative that was established to improve vascular health. M2S has a long-term commitment to vascular treatment planning, post-operative patient outcomes and medical data registries. With their contribution, M2S will hold a seat on the Industry Advisory Council, where members of the vascular medicine community come together to discuss critical topics facing the industry.
Open the Pathway was launched in July 2008 by the AVA as a fundraising effort uniting vascular surgeons and corporate partners in generating vital resources for education and research. Its mission is to ensure quality patient care through the discovery of new and safer methods to treat vascular disease. The M2S contribution helps support research conducted by vascular surgeons and keeps the specialty of vascular surgery current and in the forefront of a world where technologies and medicines are constantly changing.
“As a company that has embraced technological advances and combined them with medical imaging to provide vascular surgeons powerful informational tools, we are pleased to be part of the AVA’s mission to further advance treatments for people suffering from vascular disease all over the world,” M2S CEO Wes Chapman said.
About the American Vascular Association
AVA is the charitable foundation of the Society for Vascular Surgery (SVS), a not-for-profit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,700 vascular surgeons dedicated to the prevention and cure of vascular disease. For more information visit the SVS website at www.VascularWeb.org.
About M2S, Inc.
M2S provides 3-D endovascular imaging and data management services for endovascular treatment planning and clinical trials. It is the leading provider of AAA and TAA Treatment Planning utilizing its Preview® Software/Services and its PEMS® (Patient Endovascular Management Services) registry for the vascular surgery field. M2S develops and maintains custom image and medical data registry products for industry and clinical medicine.
M2S has been a supporter of the SVS over the past several years participating in SVS’ Vascular Annual Meeting® and other SVS related programs. For more on M2S, visit www.m2s.com.
M2S, Inc. Acquires DXA Resource Group
West Lebanon, NH –December 31, 2008: M2S Inc., a global provider of image management services for biopharmaceutical and medical device clinical trials, announced today that the company has acquired DXA Resource Group (DRG) of Westborough, Massachusetts. Founded in 2002, DRG recognized the need for cost-effective and responsive DXA (Dual- Emission X-Ray Absorptiometry) clinical quality assurance, project management and data management services to support drug development. DXA, a low-dose (1/10th of traditional x-ray) imaging modality that measures bone mineral density and body mass composition, is increasingly utilized in clinical trials to assess the safety and effectiveness of drugs under development for osteoporosis, HIV, obesity, growth hormone deficiency, endometriosis, fibroids and Gaucher’s disease.
“DRG has integrated quality service with imaging data technology, which exactly fits into the M2S mission and clinical trials image management service offering. The addition of DRG allows M2S to further expand our capabilities and therapeutic expertise, and meet the growing demand for image management services worldwide,” M2S CEO Wes Chapman said.
“Adding M2S high-speed image collection and trial management technologies to DRG’s proprietary quality system and data management, enables us to greatly increase our presence in the drug development market,” said Reta Rupich, President of DXA Resource Group.
About M2S, Inc.
M2S provides image and data management services for clinical trials sponsors in the biopharmaceutical and medical device industries, patient registry databases and is a recognized leader in 3-D endovascular treatment planning. For the past 10 years, M2S has managed, under protocol, millions of images from around the globe in various therapeutic areas and in all DICOM modalities. For more information, visit www.m2s.com.
About DXA Resource Group
DXA Resource group is a clinical trials service company focused on providing customer-centric, cost-effective quality assurance as well as data and project management for clinical trials involving Dual X-ray Absorptiometry (DXA) measurements. For more information visit www.dxaresourcegroup.com or www.m2s.com.
M2S, Inc. Achieves Milestone with 150,000th Scan for Evaluation and Surveillance of Aortic Aneurysms
West Lebanon, NH –November 7, 2008: M2S Inc., an industry leader in endovascular treatment planning and patient registries, announced today that the company has reached a new milestone, having processed over 150,000 radiographic scans for evaluation and surveillance of aortic aneurysms. With each scan received, M2S evaluates approximately 1,000 images, pushing M2S’ total images received and processed to over 150 million.
From each scan, M2S provides 3D reconstruction, measurement and registry services to physicians across the country, providing more accuracy and efficiency for endovascular aortic aneurysm pre-operative planning and post-operative surveillance. The pre- and post-operative analyses are posted to M2S’ PEMS® website, providing physicians 24/7 access to their patient data and images. Utilizing the Preview® treatment planning software from M2S, physicians can also interactively view the 3D model, as well as virtually implant stent grafts onto the 3D model to further optimize the visualization of treatment.
M2S provides image and data management services and registries for endovascular treatment planning and clinical trials. Their services are designed to improve health care and reduce the time and cost of clinical trials. For the past 10 years, M2S has worked with many of the world’s leading academic centers, pharmaceutical companies, and medical device manufacturers, managing under protocol, millions of images from around the globe.
