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The global electronic clinical outcome assessment (eCOA) solutions market is expected to reach USD 2.16 billion by 2025. The complexity in healthcare information management is anticipated to fuel the demand for eCOA solutions in coming years. These solutions deliver accurate and timely health information and reduce burden of patients enrolled in clinical trials. eCOA measures overall mental state, patient symptoms, and the progression of a disease. Electronic diaries and electronic Patient Reported Outcomes (ePRO) are a part of eCOA platforms. Electronic diaries help document patient response. These are used as support systems for ePRO. In all the applications of clinical outcome assessment systems, the compliance rates are more than 90%, which helps accelerate research procedures. In addition, assessment systems help detect probable adverse conditions in advance for patients, which is crucial for taking preventive measures to avoid adverse effects in future. The ePRO platforms transfer real-time data from the patients to healthcare professionals for accurate decision-making and better evaluation of a patient's health. Thus, the adoption of these platforms is expected to grow in near future. For more information about this report visit http://www.researchandmarkets.com/research/xcklvb/electronic To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/electronic-clinical-outcome-assessment-ecoa-solutions-market-to-reach-216-billion-by-2025---complexity-in-healthcare-information-management-is-fueling-demand---research-and-markets-300463863.html


NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


NEW YORK, May 08, 2017 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a global clinical stage biopharmaceutical company focused on the development of innovative cancer therapies, announced today that the Company’s Chief Medical Officer and Head of Business Development, Dr. Ramon Mohanlal, M.D., Ph.D., M.B.A., will present at the Evolution Summit in Miami, Chief Medical Officer Summit in Boston and Clinical Leader Forum in Philadelphia on May 8, 10 and 11, 2017, respectively. Dr. Mohanlal will discuss the “Progression of Immunotherapy and its Impact on Cancer Research” as part of his presentation at the Evolution Summit at 5:15 p.m. ET at the Ritz-Carlton Coconut Grove, as well as join a panel on “Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies” at the Chief Medical Officer Summit at 9:30 a.m. ET at the Colonnade Hotel. Finally, Dr. Mohanlal will present on the importance of “Payer Perspective, Market Access and Patient Reported Outcomes” at this year’s Clinical Leader Forum at 3:15 p.m. ET at the Hilton Philadelphia City Avenue. “It is an honor to speak at each of these prestigious conferences and present alongside some of the most exemplary leaders and pioneers in the healthcare and medical industry, opening up the dialogue around important topics that affect biopharma professionals everywhere,” said Dr. Mohanlal. “At BeyondSpring, these conversations are essential when it comes to continuing our work and growing our partnerships with other pharmaceutical professionals who have deep industry knowledge of the oncology space. Our team looks forward to capitalizing on these opportunities to help advance our lead asset, Plinabulin, which is in a Phase 3 trial as a direct anticancer agent in non-small cell lung cancer and Phase 2/3 trial for neutropenia prevention, to build toward its commercial success.” Plinabulin, a novel small molecule that alters the tumor micro-environment and stimulates dendritic cell maturation and T-cell activation, has produced encouraging data regarding the mitigation of severe neutropenia, a common and potentially life-threatening adverse effect of Docetaxel. Plinabulin can be administered one hour after chemotherapy and has the potential to be a safe, cost-effective and convenient alternative with much less bone pain than G-CSF, the current standard of care for chemotherapy-induced neutropenia. Plinabulin offers a same-day dosing advantage over G-CSF, which should be administered 24 hours after chemotherapy, per G-CSF label (next-day dosing), by which time significant damage to neutrophils has occurred. Additionally, Plinabulin has demonstrated a reduction in clinical sequelae associated with Docetaxel-induced neutropenia, including infections, sepsis, hospitalizations and the need for Docetaxel dose reductions. The Evolution Summit is a forum that brings together leading drug development executives and solution providers, with the goal of providing an intimate environment in which attendees can take part in a focused discussion on key new drivers that are shaping drug development. The Chief Medical Officer Summit is an annual gathering of physicians where they exchange best practices in the advancement of drug development within the confines of the emerging biotech space. The Clinical Leader Forum is an event that’s focused on sponsor-CRO partnerships and issues that matter most to executives at small and midsize sponsor companies. About BeyondSpring BeyondSpring is a global clinical stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with Fred Hutchinson Cancer Research Center and University of Washington. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 clinical trial as a direct anticancer agent in non-small cell lung cancer and a Phase 2/3 clinical trial in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to market. About Plinabulin Studies on Plinabulin's method of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the activation of the protein c-Jun. Activated c-Jun enters the nucleus of dendritic cells to upregulate immune-related genes, which contributes to the up-regulation of a series of genes leading to dendritic cell maturation, T-cell activation and other effects that prevent neutropenia. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the company's future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, our expectations regarding the potential safety, efficacy or clinical utility of our product candidates, or additional competition in the market. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.


DUBLIN--(BUSINESS WIRE)--ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it has been awarded a project by the US Food & Drug Administration (FDA) to validate three Patient Reported Outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. The conditions in which the endpoints will be validated are Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP) and Hospital-Acquired Bacterial Pneumonia (HABP). HABP is the second most common hospital-acquired infection and is the primary cause of death in intensive care units; ABSSSI has high rates of morbidity and other associated medical conditions whilst CABP is a major cause of mortality and morbidity worldwide, particularly among people over 65 years of age. Sponsors engaged in clinical trials for these conditions are currently using different methodologies to assess the primary endpoint as there is no qualified PRO instrument. ICON’s Clinical Outcomes Assessment (COA) group, in collaboration with the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH), will create an electronic platform to validate key PROs, allowing investigators to assess the symptoms of ABSSSI, CABP and HABP at various time points over the course of the infection and measure the effects of antibacterial drugs. The PROs will be implemented on CRF Health’s TrialMax® eCOA platform, allowing patients to use the application on a handheld device during the course of the trials. These PROs will continue to be validated and developed in accordance with the FDA guidance for PRO measures used to support labeling claims and will follow the Drug Development Tool (DDT) Qualification Program. The collaboration brings together scientists from ICON, FNIH, the FDA, the National Institute of Allergy and Infectious Diseases, the Infectious Diseases Society of America, pharmaceutical and biotechnology companies and the academic research community, to develop new approaches for evaluating the efficacy of antibiotics in future clinical trials of therapies for ABSSSI, CABP and HABP. “This project builds on our previous work with the FDA and FNIH to develop a new PRO measure for HABP trials and we’re proud to continue our support in this area of great unmet need,” commented Ramita Tandon, Executive Vice President, ICON Commercialisation & Outcomes. “Bacterial infections are becoming harder to treat as drug-resistant strains emerge at an increasing rate. ICON’s COA group has extensive experience in all areas of outcomes research to validate these important endpoints for antibacterial trials, speeding up the drug development process and delivering effective antibacterial medicines to patients.” ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 87 locations in 38 countries and has approximately 12,500 employees. Further information is available at www.iconplc.com. The Foundation for the National Institutes of Health creates and manages alliances with public and private institutions in support of the mission of the NIH, the world’s premier medical research agency. The Foundation, also known as the FNIH, works with its partners to accelerate key issues of scientific study and strategies against diseases and health concerns in the United States and across the globe. The FNIH organizes and administers research projects; supports education and training of new researchers; organizes educational events and symposia; and administers a series of funds supporting a wide range of health issues. Established by Congress in 1996, the FNIH is a not-for-profit 501(c)(3) charitable organization. Further information is available at www.fnih.org The Biomarkers Consortium is a public-private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) that endeavors to develop, validate, and/or qualify biological markers (biomarkers) to speed the development of medicines and therapies for detection, prevention, diagnosis and treatment of disease and improve patient care. Further information is available at www.biomarkersconsortium.org CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health’s TrialMax® platform consistently demonstrates the industry’s highest data accuracy, patient and site compliance, and patient retention. CRF Health’s eSource solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax® platform includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes), ClinROs (Clinician or Rater Reported Outcomes), and PerfOs (Performance Outcomes), and features TrialConsent™, an electronic solution for collecting informed consent in clinical trials. More information is at http://www.crfhealth.com/ This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.


News Article | November 29, 2016
Site: www.prnewswire.co.uk

CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has announced that it will invest in a new office location and workforce in Romania. Supporting the company's on-going growth strategy, the facility, which will be based in the economic center of lași, is due to open in the first quarter of 2017. The new office will support CRF Health's existing sites at locations across the US, UK and Finland. As Romania has a growing life sciences sector, offering strong technical competence, CRF Health's expansion to the region is tied to its commitment to providing customers with its patient-centric solutions where and when they need them. The new site will be an integrated part of the business and include research and development for CRF Health's product lines, and expanded customer service capabilities. It will bring considerable opportunities to Romania's fast-growing life sciences sector. Initially, a range of positions will be created across clinical trial and Healthcare technology R&D, software design, operations, and project management, with further opportunities expected to significantly increase by the end of 2017. "Romania is recognized as a growing market for clinical trials and technology, and the opening of our facility will enable CRF Health to offer our global customers a more extensive range of services, as well as regionalized support from our dedicated customer teams," comments Rachael Wyllie, CEO, CRF Health. "Romania has a rich talent pool of highly skilled professionals who will be able to contribute immensely to our goal of achieving better clinical trials data and helping to simplify the path to approval for life-changing medicines." The new investment in the region has been welcomed by Mayor of Iași, Mihai Chirica, "I am delighted that CRF Health has selected Iași as the location for its new base in Romania. The region has become a hub for many global companies and I look forward to the new opportunities that this investment will bring to our growing region." For further information on CRF Health, please visit http://www.crfhealth.com CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health's TrialMax® platform consistently demonstrates the industry's highest data accuracy, patient and site compliance, and patient retention. CRF Health's eSource solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax platform includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes), and ClinROs (Clinician or Rater Reported Outcomes), and features TrialConsent™, an electronic solution for collecting informed consent in clinical trials.


News Article | December 8, 2016
Site: www.prnewswire.co.uk

CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, recently announced the opening of a new office in Romania, and is now actively recruiting talent across a range of roles. The new site will support CRF Health's existing locations across the US, UK and Finland. Based in the economic centre of lași, the new site will be an integrated part of the business and include research and development for CRF Health's product lines and expanded customer service capabilities. New hires will benefit from an all-encompassing on-boarding and training program at CRF Health's existing UK and Finland offices, with ongoing training being provided by a team of international subject matter experts based on individual employee development needs. Partnering with Adecco, CRF Health is now hiring for roles across numerous departments including Business Intelligence Developers/Reporting Specialists, Software Designers, Software Architects, Testing Engineers, Research & Development Team Managers, Project Delivery teams, and Client Services roles. "The expansion into Romania is an exciting development in our on-going growth strategy," comments Sarah Dixon, Chief People Officer at CRF Health. "Romania has a growing life sciences sector and we're looking forward to welcoming highly skilled professionals within the rich talent pool that Romania has to offer. Identified by CRF Health's Performance Management Program, training will be developed by international experts and external programs, followed by clearly defined career pathways and development plans." To explore current career opportunities at CRF Health's Romanian office, please visit our Romanian job board by visiting: http://www.crfhealth.com/romania CRF Health is the leading provider of patient-centered eSource technology and service solutions for the life sciences industry. With experience in more than 800 trials, over 100 languages and across 74 countries, CRF Health's TrialMax® platform consistently demonstrates the industry's highest data accuracy, patient and site compliance, and patient retention. CRF Health's eSource solutions improve trial engagement by fitting into the lives of patients and seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax platform includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported Outcomes), and ClinROs (Clinician or Rater Reported Outcomes), and features TrialConsent™, an electronic solution for collecting informed consent in clinical trials.


SOLOTHURN, Switzerland--(BUSINESS WIRE)--DePuy Synthes, part of the Johnson & Johnson Family of Companies, today announced that implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirm positive early results for DePuy Synthes’ ATTUNE® Knee System.1 These data add to recent UK Joint Registry evidence which indicate that survivorship for the ATTUNE Knee compares favorably to other cemented knee systems in its class.2 In addition, recently-presented interim data on two studies suggest improved patient reported outcomes measures with the ATTUNE Knee compared to other leading knee systems.3 Per the 2016 AOANJRR, in which 4,831 ATTUNE Knees are being tracked, the ATTUNE Knee estimated cumulative percent revision was 0.5% (ATTUNE Cruciate Retaining Knee) and 0.4% (ATTUNE Posterior Stabilized Knee) at one year.1 This compares favorably to the overall class of cemented total knee arthroplasty (TKA) at one year, which has an estimated cumulative percent revision of 1.0%.1 In addition, interim results from an ongoing study of patients implanted with ATTUNE Posterior Stabilized (PS)TKA Knees showed a reduced incidence of symptomatic crepitus that was half of that compared to non-ATTUNE PS TKA Knees at a minimum of one year .4 “There is a steady cadence of evidence for the ATTUNE Knee that suggests improved outcomes and functional performance3,5” said Paul Voorhorst, Vice President of Clinical Research for DePuy Synthes Joint Reconstruction. “We are committed to ongoing monitoring of both the outcomes and economic benefits of this new technology.” A large U.S. hospital administrative database review showed results that ATTUNE Knee patients in this review had a 39% lower adjusted odds of discharge to a skilled nursing facility compared to patients in this review who received a TKA with a Triathlon® Knee.6 “These promising early results are encouraging for patients, healthcare providers and payers, and underline the importance of our robust evidence generation program for the ATTUNE Knee,” said Christina Farup, Vice President, Health Economics and Market Access, Johnson & Johnson Medical Devices. “We designed the ATTUNE Knee System with both patients and providers in mind to help health care systems increase patient satisfaction, improve clinical outcomes and reduce overall health care costs.” The ATTUNE Knee evidence generation program gathers information from many sources, including other joint registries. In addition to the AOANJRR, the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) also indicated that the ATTUNE Knee System compares favorably to other cemented total knee systems in its class.2 Per the 2016 NJR, the ATTUNE Knee estimated cumulative percent revision was 1.39% at 3 years (98.61% survivorship) for 4,463 knees, comparing favorably to the class of Cemented TKA that has an estimated cumulative percent revision of 1.50%.2 Advancements in TKA surgery systems, such as the ATTUNE Knee, may not only benefit patients, but the healthcare system as a whole because patients may be able to leave the hospital sooner and return to normal activity. A 2013 study published in The Journal of Bone and Joint Surgery found that societal savings, such as decreased disability costs, return to independent living, and increased work productivity, far exceeded direct costs [of TKA surgery].7 Global thought-leader surgeons, engineers, and experts in fields of study such as kinematics, anthropometrics, polyethylene wear and design collaborated to develop and test the ATTUNE Knee System. Extensive research and science has gone into the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers. DePuy Synthes, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com. The third party trademarks used herein are the trademarks of their respective owners. Registered Office: Johnson & Johnson Medical Limited, PO BOX 1988, Simpson Parkway, Livingston, West Lothian, EH54 0AB, United Kingdom. Incorporated and registered in Scotland under company number SC132162 2. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man Annual Report. (2016). Tables 3.28 and 3.24 (a). Retrieved from: http://www.njrcentre.org.uk/njrcentre/Portals/0/Documents/England/Reports/13th%20Annual%20 Report/07950%20NJR%20Annual%20Report%202016%20ONLINE%20REPORT.pdf 3. Hamilton, W., Himden, S., Brenkel, I., Clatworthy, M., Dwyer, K., Lesko, J. and Kantor, S. Early Patient Reported Outcomes With New Primary vs. Contemporary Total Knee Arthroplasty: A Comparison of Two Worldwide, Multi-Center Prospective Studies. International Society for Technology in Arthroplasty (ISTA): e-Poster, 5-8 October 2016, Boston, MA. Based on interim data. The leading knee systems included: 89% P.F.C.® SIGMA®, 3% Zimmer NexGen®, 7% Stryker Triathlon®, 1% Other. 4. Toomey, S., Daccach, J., Shah, J., Himden, S., Lesko, J. and Hamilton, W. Comparing the Incidence of Patellofemoral Complications in a New Total Knee Arthroplasty (TKA) System vs. Currently Available Products in Two, Worldwide, Multi-Center, Prospective Clinical Studies. While not statistically significant, the trend is promising and follow-up is ongoing. Based on interim data. 5. Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE® Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418(1). In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE Knees and 40 patients with SIGMA® CR150 Knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent. 6. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon® Total Knee Systems: Real-World Length of Stay and Discharge Status." Value in Health 19(3): A298. Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE® Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon®. 7. Ruiz D, Koenig L, Dall T, et al. The Direct and Indirect Costs to Society of Treatment for End-Stage Knee Osteoarthritis. J Bone Joint Surg Am., 2013; 95: 1473-80.


News Article | October 28, 2016
Site: www.eurekalert.org

DARIEN, IL - A new study shows that positive airway pressure (PAP) therapy for sleep apnea may have a positive impact on sleep-related functional outcomes among patients who also suffer from hypertension. The findings suggest that untreated sleep apnea may explain the quality of life impairments reported by many patients with high blood pressure. Results show consistent improvement of patient-reported outcomes in response to PAP therapy for sleep apnea in hypertensive patients. The study found significant improvement in daytime sleepiness, depressive symptoms and fatigue severity within a year following treatment initiation. Results were significant even in patients with resistant hypertension. "We found that consistently and notably there was no difference in patient-reported outcomes between resistant hypertension and non-resistant hypertension groups," said lead author Harneet Walia, MD, assistant professor of family medicine in the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. "What we found was that the improvement in the patient-reported outcomes was more pronounced in those with objective adherence to PAP therapy." Study results are published in the Oct. 15 issue of the Journal of Clinical Sleep Medicine. According to the American Academy of Sleep Medicine, 30 to 40 percent of patients with hypertension also suffer from obstructive sleep apnea, which is a sleep-related breathing disorder characterized by repetitive episodes of complete or partial upper airway obstruction occurring during sleep. Adhering to sleep apnea treatment is a proven means of decreasing blood pressure and improving overall health. The single-center, observational study involved nearly 900 patients with sleep apnea and hypertension, of which 15 percent had resistant hypertension. Their mean age was 58 years, 52 percent were male, and 72 percent were Caucasian. They were being treated with PAP therapy through the Cleveland Clinic Sleep Disorders Center. Questionnaire-based patient reported outcomes were evaluated using the Epworth Sleepiness Scale, Patient Health Questionnaire-9 (depression), and Fatigue Severity Scale. The authors report that to their knowledge no previous study has examined changes in sleep-related functional outcomes with PAP therapy in a cohort comprising patients with hypertension, including some with resistant hypertension. The study was funded by grants from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), and by a Scholar Award from the Center for Outcomes Research and Evaluation at the Cleveland Clinic Neurological Institute. To request a copy of the study, "Impact of Sleep-Disordered Breathing Treatment on Patient Reported Outcomes in a Clinic-Based Cohort of Hypertensive Patients," or to arrange an interview with the study author or an AASM spokesperson, please contact Senior Communications Coordinator Amy Pyle at 630-737-9700, ext. 9366, or apyle@aasmnet.org The monthly, peer-reviewed Journal of Clinical Sleep Medicine is the official publication of the American Academy of Sleep Medicine, a professional membership society that improves sleep health and promotes high quality, patient-centered care through advocacy, education, strategic research, and practice standards (http://www. ). More information about sleep, and a searchable directory of AASM-accredited sleep centers, is available at http://www. .


News Article | December 14, 2016
Site: www.marketwired.com

SAN FRANCISCO, CA--(Marketwired - December 14, 2016) - PharPoint Research, a North Carolina-based Contract Research Organization (CRO), has committed to a contractual expansion in the number of clinical trials they will conduct with Medrio, a Software as a Service (SaaS) company providing electronic data capture (EDC) services to clinical trials. This agreement is a direct result of the growth of PharPoint Research, as evidenced by their recent Fast 50 award by the Triangle Business Journal. The commitment between the two companies strengthens their partnership and reflects the value that PharPoint Research has placed in Medrio's services during this period of rapid growth. PharPoint Research views Medrio as one of the top EDCs for quick study build and high data quality, and therefore as conducive to the efficiency that PharPoint Research will require as it continues to emerge as an industry leader and one of the busiest CROs in the region. "With our growth, we continue to utilize Medrio as our primary tool for data capture," said Moya Hawkins, Director of Data Management at PharPoint Research. "Medrio helps us to facilitate a streamlined and rapid approach to study start-up while maintaining clean data throughout a study's lifecycle." PharPoint Research and Medrio have enjoyed a mutually productive relationship for many years, beginning in 2010 when PharPoint put their first project in Medrio's EDC system. In 2013, PharPoint Research joined Medrio's Partner Program, through which Medrio provides extensive sales and marketing support, offers previews of upcoming product developments, facilitates new business opportunities for participating CROs, and more. PharPoint Research has found the Partner Program to be a valuable resource throughout the journey toward its current growth, and continues to take advantage of the program's benefits. Of the increased use of Medrio by PharPoint Research in the coming year, Mike Novotny, founder and CEO of Medrio, said, "Nothing could be more rewarding than knowing that PharPoint Research has found the capabilities of our software, and the benefits of our partner program, to be so helpful during their explosive growth. We're honored that they've chosen to expand their business with us over the next year." PharPoint Research is a full-service contract research organization (CRO) that specializes in Project Management, Clinical Monitoring, Data Management and Biostatistics. The company is uniquely poised to serve the needs of pharmaceutical, biotechnology, and medical device development organizations. PharPoint Research is experienced in strategic consulting engagements and Phase 1 through Phase 4 clinical research projects across a variety of therapeutic areas, including infectious disease, oncology, CNS, cardiovascular, and rare disease indications. PharPoint Research is headquartered in North Carolina, with strategic operations service provider partners around the world, including North and South America, Europe, and Asia-Pacific. For more information, please visit pharpoint.com. The Triangle Business Journal, a weekly business newspaper, is the leading provider of local business news for the Raleigh-Durham–Chapel Hill area of North Carolina. Each year the Triangle Business Journal honors the fastest growing companies in the Research Triangle area of North Carolina with the Fast 50 Awards. PharPoint Research received the award in recognition of the significant growth that the company has experienced over the last 12 months. This growth is the direct result of providing excellent client service, expertise and uncompromised quality to the pharmaceutical and biotechnology industry. This is the fourth time since 2011 that PharPoint Research has won this annual award. Medrio offers an integrated eClinical software platform with a fully hosted EDC system. Our technology features an easy-to-use drag-and-drop interface, allowing study managers to build their studies in days instead of months without requiring any programming. Medrio's new mobile suite, mSource, supports both event-based and subject-based workflows, offline data entry, and Patient Reported Outcomes (PRO). Although Medrio has extensive experience in all study phases, our m1 application leads the way in early-phase and Phase 1 trials, with over 500 Phase 1 trials to date. Medrio costs up to 75% less than traditional EDC solutions. For more information, please visit our website. To schedule a demo and learn more about Medrio's Partner Program, please submit your information here and a member of our team will be in touch shortly.


TORONTO, ON--(Marketwired - October 28, 2016) - During a live broadcast on Thursday, November 10 at 11:00am EDT, featured presenters from inVentiv Health will share data collected through a survey of managed market payers in the United States, and the potential issues and insights revealed at its ASCO 2016 Roundtable with Pharmaceutical Executive. Also included will be recommendations for how the industry will move forward to overcome the obstacles in the path of acceptance of PRO as an appropriate measure of the patient's voice in cancer care. Patient-reported outcomes (PRO) promise better information on the patient's actual experience in drug trials and treatment, and they are now receiving close attention from regulators, industry, and patient advocates. In May of 2016, inVentiv Health conducted a survey of managed market payers in the United States on the potential value of PRO in the evaluation of drugs. Despite the current focus on PRO including editorials in New England Journal of Medicine, Journal of Clinical Oncology, and JAMA Oncology, those surveyed express overt ambivalence about PRO as a decision-making tool, even in costly, hard-to-treat cancers. The full potential of a drug evaluation model that incorporates insights on the real-life patient experience hangs in the balance. A follow-up roundtable, sponsored by Pharmaceutical Executive, was conducted to discuss the results of this survey in Chicago at the ASCO 2016 Annual Meeting. The discussions there revealed that leaders representing different segments of the industry were disappointed, but not surprised, by the survey results. Patients may not feel the issues that matter to them are acknowledged in the information hierarchy that dominates clinical decisions. Industry builds PRO data instruments with exhaustive patient input and focuses on collecting more than 85% complete data, yet payers feel that this data is spotty, inconsistent, and lacking impact on the costs of care. Thus the onus is on all of those entrusted with the execution of modern clinical trials-including regulators, industry, as well as the patient-to make the case for PRO through greater methodological clarity and better alignment with safety, efficacy, and other data assessment approaches like patient registries. If PRO can be effectively used to fully characterize the impact of new therapies, they will have a greater acceptance in drug evaluation by payers. To learn more or register for this complimentary event, visit Xtalks' website: Patient Centered Strategies for Clinical Trials & Treatment: Reactions to Payer Perspectives on Patient Reported Outcomes. inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit inVentivHealth.com. Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, health care centers, etc.) turn to Xtalks for access to quality content. Xtalks helps life science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit http://xtalks.com.

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