Advanced Bionics to Use invivodata's Electronic Diary in Migraine Trial; Pain Trial Experience is Critical Factor in eDiary Decision.PITTSBURGH -- invivodata(R) inc., the industry leader in electronic patient reported outcomes (ePRO) solutions for global clinical research, today announced that DiaryPRO(TM), its handheld electronic diary (eDiary) system, will be used by Advanced Bionics(R) Corp. to collect primary efficacy data in a clinical trial of its Precision(R) implantable neurostimulation device for migraine migraine (mī`grān), headache characterized by recurrent attacks of severe pain, usually on one side of the head. It may be preceded by flashes or spots before the eyes or a ringing in the ears, and accompanied by double vision, nausea, management. Approximately 150 adults with drug-refractory migraine will use DiaryPRO to accurately record the frequency and severity of migraine attacks during this trial. Advanced Bionics will analyze the PRO data collected on DiaryPRO to determine the safety and effectiveness of the Precision neurostimulator among patients with this disease state. "We chose to work with invivodata based on its knowledge and experience conducting pain trials and its proven ability to deliver timely, accurate PRO data to sponsors," said AnnaMarie Daniels, vice president of clinical research at Advanced Bionics. "Having worked with nearly 5,000 migraine sufferers to date, invivodata truly understands the needs of our patient population. We are confident that it will help these patients provide the critical PRO data we need." The Precision device, which is implanted im·plant v. im·plant·ed, im·plant·ing, im·plants v.tr. 1. To set in firmly, as into the ground: implant fence posts. 2. under the skin, is intended to relieve the symptoms of migraine headache Migraine Headache Definition Migraine is a type of headache marked by severe head pain lasting several hours or more. Description Migraine is an intense and often debilitating type of headache. in patients who do not respond to currently available medical treatments. "This study represents an important step forward in Advanced Bionics' ongoing efforts to bring relief to pain sufferers," said Doug Engfer, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of invivodata. "We are thrilled thrill v. thrilled, thrill·ing, thrills v.tr. 1. To cause to feel a sudden intense sensation; excite greatly. 2. To give great pleasure to; delight. See Synonyms at enrapture. to work with Advanced Bionics as it continues to explore the full potential of this novel device and improve the quality of life for patients suffering from migraine." About invivodata inc. invivodata (http://www.invivodata.com) combines behavioral science behavioral science n. A scientific discipline, such as sociology, anthropology, or psychology, in which the actions and reactions of humans and animals are studied through observational and experimental methods. , information technology and clinical expertise to capture clinical trial data of the highest integrity directly from patients. invivodata's electronic patient reported outcomes (PRO) system delivers high-quality patient self-reported data by driving patient compliance with the protocol and eliminating recall biases that plague plague, any contagious, malignant, epidemic disease, in particular the bubonic plague and the black plague (or Black Death), both forms of the same infection. self-report studies. The invivodata solution, which includes DiaryPRO for real-time PRO data collection and SitePRO(TM) for site-based PRO data collection, provides access to study data, giving researchers and sponsors visibility into study progress and improving trial efficiencies. invivodata's solution has been used in more than 120 trials involving over 50,000 patients. It has also collected over 50 million patient-initiated records, and is the only eDiary system that has delivered the primary efficacy data for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. drug approvals. invivodata inc. is a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. with global headquarters in Pittsburgh, Pa., USA; its European headquarters are in London, England; and its technology development center is in Scotts Valley, Calif., USA. |
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