Press Room
New Guidance for Waiving Consent in EmergenciesCHICAGO – August 4, 2011 The Food and Drug Administration (FDA) recently released guidance for institutional review boards (IRBs), clinical investigators, and sponsors on Exception from Informed Consent Requirements for Emergency Research. FDA Increases Frequency of Research Site AuditsCHICAGO – June 30, 2011 In response to increased funding of the Federal Drug Association’s (FDA) Bioresearch Monitoring Program focused on ensuring the maintenance of human subject protection, the agency has increased research site audits by 76 percent from 2008 to 2010. How High is the Confidence Level for the Integrity of your Site’s IT Systems Used in Research?CHICAGO – May 5, 2011 The Food and Drug Administration (FDA) released guidance in May 2007 supplementing 21 CFR Part 11 to assist the industry in the use of computerized systems in research. These suggestions are aimed to provide confidence in the reliability, quality, and integrity of electronic records used in clinical investigations. FDA Amends Informed Consent RegulationsCHICAGO – February 11, 2011 The Food and Drug Administration (FDA) released an amendment to 21 CFR Part 50 relating to the Basic Elements of Informed Consent. This amendment will require sites participating in drug and/or device clinical trials to add a statement specified by the FDA into informed consents pertaining to study results being publically accessible on the government’s clinical trial listing website (ClinTrials.gov). The site will not include information that can identify participants, but instead provides an aggregate summary of a study’s results. Financial Challenges are Number One Concern of HospitalsCHICAGO – January 25, 2011 According to the American College of Healthcare Executives (ACHE), financial challenges ranked as the top concern of hospital CEOs in 2010. The focus of that concern relates to government and private payor reimbursement, bad debt and increasing costs. GuideStar® Helps Missouri Community Develop Hospital Research ProgramKANSAS CITY – December 17, 2010 A recent article in the Kansas City Business Journal highlights GuideStar Clinical Trials Management in an article about community hospitals developing clinical research programs. Pharmaceutical and Device Company Funded Clinical Research Continues to Move into Community Healthcare SettingsCHICAGO – September 16, 2010 During the past two decades, industry-sponsored clinical trials have dramatically shifted away from academic medical centers (AMCs) to community-based research settings. New data provided by Tufts Centers for the Study of Drug Development and reported by industry news publication CenterWatch Monthly September 2010 edition indicates that shift has continued.GuideStar® Board Member Dr. John Elstrott Named Chairman of Whole Foods MarketCHICAGO – January 4, 2010 John B. Elstrott, PhD, a member of the Board of Directors of GuideStar® Clinical Trials Management, has been named Chairman of the Board of Whole Foods Market. GuideStar® is a national clinical research company offering comprehensive clinical trials services to medical facilities as a completely outsourced option.
Hospitals and Physician Groups Outsource Clinical Research ServicesCHICAGO – December 12, 2009 While the practice of outsourcing is nothing new to hospital systems and physician groups—particularly in the areas of administrative support, housekeeping and food service, there has been an upward trend in contracting out clinical services. Leading areas for outsourcing include dialysis services, sleep disorders, diagnostic imaging, laboratory services and physical therapy. Clinical Research Embraced by More Leading Community Hospitals and Private Physician Groups Due to Extensive BenefitsCHICAGO – October 1, 2009 As new models for conducting clinical trials are emerging in the U.S., community hospitals and private physician practices are increasingly choosing to participate in research, an initiative that benefits medical science and the lives of patients. Health care facilities are seeing tangible benefits such as enhancing an organization’s identity, as well as its bottom line. GuideStar® Clinical Trials Management Provides Outsourced Clinical Research Services to Hospitals, Physician Practice Groups and HealthCare CentersCHICAGO – August 1, 2009 Clinical research has long been a point of distinction for the hospitals and clinics auspicious enough to house those divisions within their walls. GuideStar® Clinical Trials Management, the only national clinical research company that offers comprehensive trials services to medical facilities, aims to level the playing field for a wider cross-section of hospitals, physician practice groups and health care centers. |
Community Hospitals Benefit from Implementing Research Programs
GuideStar Delivers Clinical Trials Expertise to Hospitals