Emissary - A Contract Research Organization (CRO) accelerating clinical research trials Emissary International is a contract clinical research organization (CRO). http://www.emissary.com/907-clinical-research-articles 2017-10-17T17:49:27-05:00 Emissary.com smayo@emissary.com Joomla! - Open Source Content Management Surviving an FDA Inspection of Your Clinical Trial Site 2008-03-12T11:39:32-05:00 2008-03-12T11:39:32-05:00 http://www.emissary.com/16-clinical-research-articles/focus-on-clinical-investigators-a-coordinators/42-fda-inspection <p><span>The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA) has conducted clinical site inspections under what is known as the Bioresearch Monitoring Program. The agency now conducts several hundred inspections of clinical investigators annually to obtain compliance with the regulations and to ensure that data submitted to the FDA are substantiated by appropriate records. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span>The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA) has conducted clinical site inspections under what is known as the Bioresearch Monitoring Program. The agency now conducts several hundred inspections of clinical investigators annually to obtain compliance with the regulations and to ensure that data submitted to the FDA are substantiated by appropriate records. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Physicians find clinical research brings income and treatment options 2002-08-02T00:01:15-05:00 2002-08-02T00:01:15-05:00 http://www.emissary.com/16-clinical-research-articles/focus-on-clinical-investigators-a-coordinators/57-clinical-research-benefits-for-physicians <p><span style="line-height: 1.3em;">Trying their patients: practitioners find clinical research projects, chosen well, can create extra income and widen treatment options.</span></p> <p class="browsecontent"> </p> <p>Phase III clinical research has the potential for eye-catching margins, but private practitioners who enter the, field with that motive seldom stay. The reason? Financial returns don't come easily, and the process is fraught with opportunities for failure.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span style="line-height: 1.3em;">Trying their patients: practitioners find clinical research projects, chosen well, can create extra income and widen treatment options.</span></p> <p class="browsecontent"> </p> <p>Phase III clinical research has the potential for eye-catching margins, but private practitioners who enter the, field with that motive seldom stay. The reason? Financial returns don't come easily, and the process is fraught with opportunities for failure.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Emissary Technology Key to Enrolling First Patient Within 7 Days of FDA Approval of a Dialysis Graft Trial 2002-07-19T00:12:10-05:00 2002-07-19T00:12:10-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/58-emissary-technology-key-to-fast-enrollment <p><span>Emissary Inc. has been selected by Novoste Corporation (Nasdaq:NOVT) to collaborate on monitoring and clinical trial management of Novoste's BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span>Emissary Inc. has been selected by Novoste Corporation (Nasdaq:NOVT) to collaborate on monitoring and clinical trial management of Novoste's BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Emissary Key to Radiation Study Success 2008-03-23T00:19:04-05:00 2008-03-23T00:19:04-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/53-radiation-study Aaron Lorenzo for Medical Device Daily <p><span>Looking to increase the efficiency of its recently approved beta radiation trial, Novoste (Norcross, Georgia) selected contract research organization Emissary (Austin, Texas) to run the show. Emissary's TeamTrials electronic data capture technology will be used to monitor and manage the BRAVO (Beta Radiation for treatment of Arterial-Venous dialysis graft Outflow) clinical trial. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span>Looking to increase the efficiency of its recently approved beta radiation trial, Novoste (Norcross, Georgia) selected contract research organization Emissary (Austin, Texas) to run the show. Emissary's TeamTrials electronic data capture technology will be used to monitor and manage the BRAVO (Beta Radiation for treatment of Arterial-Venous dialysis graft Outflow) clinical trial. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> More Trials & Tribulations for Clinical Monitoring 2005-10-01T01:00:00-05:00 2005-10-01T01:00:00-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/38-tribulations Maria Fontanazza for Medical Device & Diagnostic Industry Magazine <p><span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: small;">Clinical trial litigation is on the rise in the drug arena, and the effects could soon spread to the device industry. The Legal Times (Washington, DC) has reported that lawsuits are increasing and often pursue every person and institution in their paths. If device manufacturers want to avoid legal action, they need to protect themselves by making sure they’re not cutting corners. </span></p> <p><span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: small;">The first step is to hire the proper staff to monitor clinical trials, says Steven Mayo, president of Austin, TX–based Emissary International, a contract research organization. "America seems to be in a lawsuit craze, and the number of high-profile lawsuits seems to be increasing," says Mayo. "The class-action lawsuit trend is a negative [development] that’s really affecting [the device] industry."</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: small;">Clinical trial litigation is on the rise in the drug arena, and the effects could soon spread to the device industry. The Legal Times (Washington, DC) has reported that lawsuits are increasing and often pursue every person and institution in their paths. If device manufacturers want to avoid legal action, they need to protect themselves by making sure they’re not cutting corners. </span></p> <p><span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: small;">The first step is to hire the proper staff to monitor clinical trials, says Steven Mayo, president of Austin, TX–based Emissary International, a contract research organization. "America seems to be in a lawsuit craze, and the number of high-profile lawsuits seems to be increasing," says Mayo. "The class-action lawsuit trend is a negative [development] that’s really affecting [the device] industry."</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Clinical Trial Accrual Hampered by Many Factors 2002-10-04T01:00:00-05:00 2002-10-04T01:00:00-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/37-clinical-trial-accrual-hampered-by-many-factors Healthcare Advisory Board <p><span>In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician enthusiasm, design requirements, and enrollment procedures now pose large barriers to patient accrual, finds two new Cancer studies. Since previous research has predominantly focused on patient and physician perspectives, Canadian researchers interviewed clinical research associates (CRAs), whose work spans all stages of clinical trials, to gain new insight into the factors influencing enrollment. The CEO of an Austin, Texas-based contract research organization (CRO), which designs trials and staffs CRAs, told the Watch (9/24/02) that the strict participation guidelines for oncology-related clinical trials make meeting accrual goals for experimental cancer therapies particularly difficult. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span>In recent years, cancer patients are more knowledgeable and willing to participate in clinical trials, but issues pertaining to physician enthusiasm, design requirements, and enrollment procedures now pose large barriers to patient accrual, finds two new Cancer studies. Since previous research has predominantly focused on patient and physician perspectives, Canadian researchers interviewed clinical research associates (CRAs), whose work spans all stages of clinical trials, to gain new insight into the factors influencing enrollment. The CEO of an Austin, Texas-based contract research organization (CRO), which designs trials and staffs CRAs, told the Watch (9/24/02) that the strict participation guidelines for oncology-related clinical trials make meeting accrual goals for experimental cancer therapies particularly difficult. </span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Emissary Presents at Southwest Equity Capital Summit 2002-10-02T23:32:56-05:00 2002-10-02T23:32:56-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/55-emissary-presents-at-southwest-equity-capital-summit <p><span>AUSTIN, Texas -- Emissary Inc. today announced that it will participate in the 2002 Southwest Equity Capital Summit organized by the Capital Network October 2-3 in Richardson, Texas. Steven Mayo, founder and CEO of Emissary, will present the company's plans to streamline drug and medical device research studies with a new Web-based software initiative.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span>AUSTIN, Texas -- Emissary Inc. today announced that it will participate in the 2002 Southwest Equity Capital Summit organized by the Capital Network October 2-3 in Richardson, Texas. Steven Mayo, founder and CEO of Emissary, will present the company's plans to streamline drug and medical device research studies with a new Web-based software initiative.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Emissary Launches TeamTrials Clinical Research Platform for Electronic Data Capture (EDC) 2002-10-22T23:47:24-05:00 2002-10-22T23:47:24-05:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/56-emissary-launches-teamtrials-electronic-data-capture-edc <p class="articlecontenttitle">AUSTIN, Texas--(BUSINESS WIRE)--Oct. 22, 2002 <br /> <br />Contract clinical research organization Emissary Inc. today introduced TeamTrials, a comprehensive Web-based software platform for conducting clinical trials. <br /> <br />Emissary is using TeamTrials to streamline its customers' research studies, enabling faster, more efficient trials for new medical devices, drugs, biopharmaceuticals and other life-improving medical products.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p class="articlecontenttitle">AUSTIN, Texas--(BUSINESS WIRE)--Oct. 22, 2002 <br /> <br />Contract clinical research organization Emissary Inc. today introduced TeamTrials, a comprehensive Web-based software platform for conducting clinical trials. <br /> <br />Emissary is using TeamTrials to streamline its customers' research studies, enabling faster, more efficient trials for new medical devices, drugs, biopharmaceuticals and other life-improving medical products.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> Clinical Trial Outsourcing Emerging as a Key Trend in Drug Research And Development Markets 2001-12-22T22:24:54-06:00 2001-12-22T22:24:54-06:00 http://www.emissary.com/12-clinical-research-articles/referencearticles/54-cro-outsourcing-trends <p><span style="line-height: 1.3em;">TORONTO, Nov. 12 /PRNewswire/ -- </span></p> <p class="browsecontent"><br />Contract research organizations (CROs) are a growing trend among the pharmaceutical and biotechnology sectors as these companies look to reduce the costs of drug development. However, there are tradeoffs between the size of a CRO and the therapeutic and local expertise dedicated to individual projects.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p><span style="line-height: 1.3em;">TORONTO, Nov. 12 /PRNewswire/ -- </span></p> <p class="browsecontent"><br />Contract research organizations (CROs) are a growing trend among the pharmaceutical and biotechnology sectors as these companies look to reduce the costs of drug development. However, there are tradeoffs between the size of a CRO and the therapeutic and local expertise dedicated to individual projects.</p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form 2009-02-24T11:33:05-06:00 2009-02-24T11:33:05-06:00 http://www.emissary.com/11-clinical-research-articles/clinical-research-professional/62-fda-1572-guidance <p> <span style="line-height: 1.3em;">In July 2008, FDA released a </span><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf" title="" style="line-height: 1.3em;">draft guidance</a><span style="line-height: 1.3em;"> to answer frequent questions about </span><a href="http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.doc" title="" style="line-height: 1.3em;">Form FDA-1572</a><span style="line-height: 1.3em;">, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. </span><strong style="line-height: 1.3em;">Keep in mind that this is only a draft</strong><span style="line-height: 1.3em;">; with the recent change in administration this draft may never be released as final or it may be significantly modified.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p> <p> <span style="line-height: 1.3em;">In July 2008, FDA released a </span><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0406-gdl.pdf" title="" style="line-height: 1.3em;">draft guidance</a><span style="line-height: 1.3em;"> to answer frequent questions about </span><a href="http://www.fda.gov/opacom/morechoices/fdaforms/FDA-1572.doc" title="" style="line-height: 1.3em;">Form FDA-1572</a><span style="line-height: 1.3em;">, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. </span><strong style="line-height: 1.3em;">Keep in mind that this is only a draft</strong><span style="line-height: 1.3em;">; with the recent change in administration this draft may never be released as final or it may be significantly modified.</span></p> <p class="feed-readmore"><a target="_blank" href ="">Read More...</a></p>