Outcome Company Profile

13:27 EST 11th December 2018 | BioPortfolio

Outcome is the leading provider of strategies and solutions designed to meet the unique needs of the post-approval market. The Company focuses on program strategy and the practical deployment of registries, Phase IV studies, and risk management programs, including the application of state-of-the-art technology to better achieve the unique goals and requirements of the post-approval phase.Outcome's market-leading technology is distinguished by its scalability, performance and reliability. Additionally, the technology requirements of post-marketing programs are different than those of pre-approval trials. Ease of use, faster response times, better reporting and more value added features are critical for success.
Backed by expertise and experience in over 30 therapeutic areas, Outcome has designed, developed and managed an industry leading number of post-approval studies including more than 60 registries. These include many of the largest and most well-recognized programs for disease outcomes and safety/risk management. An Outcome registry has also received a 2004 Innovation Award from the Department of Health and Human Services. With more than 1 million patients enrolled in studies powered by Outcome and over 3,000 sites logging on to the Outcome system daily, the Company has by far the most widely used system in the industry. Outcome is headquartered in Cambridge, Mass.


201 Broadway
United States of America


Phone: (617) 621-1600
Fax: (617) 621-1620

News Articles [11 Associated News Articles listed on BioPortfolio]

Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome

CHESTERBROOK, Pa., Oct. 11, 2018 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ: TRVN), today announced the outcome of the meeting of the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic...

Arch Therapeutics Announces Positive Outcome of Ruling from Japanese Intellectual Property High Court

FRAMINGHAM, Mass., Dec. 04, 2018 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, is ...

ARCA Biopharma Announces Positive Outcome of End-of-Phase 2 Meeting With FDA on Gencaro Development for Atrial Fibrillation

Single Phase 3 trial may be sufficient for approval of atrial fibrillation indicationPhase 3 clinical trial Special Protocol Assessment submission anticipated 3Q2018Gencaro is in development as poten...

Clinically Meaningful Outcome in NIH Trial of MPC-150-IM for Heart Failure LVAD Recipients Provides Pathway for Potential Regulatory Approval

NEW YORK and MELBOURNE, Australia, Nov. 11, 2018 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that results from a 159-patient randomized, sham-controlled Phase 2 tri...

Asterias Biotherapeutics Announces Positive Outcome from Data Review from OPC1 Spinal Cord Injury Study

Meeting with Food and Drug Administration Remains on Track for End of 2018 FREMONT, Calif., Oct. 31, 2018 (GLOBE NEWSWIRE) -- Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology ...

Tonix Pharmaceuticals Announces Outcome of Interim Analysis for Phase 3 HONOR Study of Tonmya® in Military-Related PTSD

HONOR Study will Stop due to Inadequate Separation from Placebo at Week-12 Results at Week-4 Demonstrated Meaningful Clinical Improvement Company Plans to Meet with FDA to Discuss Next Steps for ...

AzurRx BioPharma Announces Positive Outcome with MS1819-SD Showing Statistically Significant Efficacy in a Phase IIa Exocrine Pancreatic Insufficiency Trial in Chronic Pancreatitis

NEW YORK, Sept. 24, 2018 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therap...

Asterias Biotherapeutics Announces Positive Outcome from Safety Review Committee for AST-VAC2; Recommends Continuation of Clinical Trial in Non-Small Cell Lung Cancer (NSCLC)

FREMONT, Calif., July 11, 2018 (GLOBE NEWSWIRE) -- Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cellular immunotherapies to treat cancer and c...

Drugs and Medications [1 Associated Drugs and Medications listed on BioPortfolio]

Cedax [Pernix Therapeutics, LLC]

CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension)

PubMed Articles [18 Associated PubMed Articles listed on BioPortfolio]

Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME® randomised trial.

After coronary artery bypass graft (CABG) surgery in individuals with type 2 diabetes, there remains a considerable residual cardiovascular risk. In the EMPA-REG OUTCOME® trial in participants with t...

Empagliflozin and kidney outcomes in Asian patients with type 2 diabetes and established cardiovascular disease: results from the EMPA-REG OUTCOME trial.

In the EMPA-REG OUTCOME trial, empagliflozin added to standard of care improved clinically relevant kidney outcomes by 39%, slowed progression of chronic kidney disease, and reduced albuminuria in pat...



To compare outcomes in dense vitreous hemorrhage versus mild vitreous hemorrhage due to nontraumatic posterior vitreous detachment.


To report a case of successful closure of macular hole after surgery in a patient with choroidal coloboma.

Clinical Trials [30 Associated Clinical Trials listed on BioPortfolio]

Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).

Purpose: The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were, at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate th...

Patient-reported Outcome Scale in Acute Pancreatitis

The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP) based ...

Comparing Program Options for Latinos With Diabetes

BACKGROUND AND SIGNIFICANCE: Diabetes is a national health problem, yet Latinos from low-income households are at greater risk. Although guidelines recommend that patients learn self-mana...

EMPA Acute Heart Failure

In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin ...

Otologic and Rhinologic Outcomes in Children With Clef Palate

OBJECTIVE: To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft. DESIGN: Monocentric retrospective and...

Companies [8 Associated Companies listed on BioPortfolio]

Outcomes Pharmaceutical Health Care

Outcome is the leading provider of patient registries, studies, quality improvement programs, and integrated technologies for evaluating real-world outcomes. Outcome provides serv...


Outcome is the leading provider of strategies and solutions designed to meet the unique needs of the post-approval market. The Company focuses on program strategy and the practical deployment of regis...

Outcome Sciences, Inc.

Outcome is the leading provider of patient registries, studies, quality improvement programs, and integrated technologies for evaluating real-world outcomes. Outcome provides serv...

NeuroVive Pharmaceutical AB

NeuroVive Pharmaceutical AB ( is a Swedish drug development company whose primary mission is to develop drugs for the treatment of acute brain injury, reperfusion injury in myocard...

N.C. Stroke Association

NCSA is a 501 (c) 3 organization founded in 1998 by a group of physicians and lay people who saw the need to address the state’s increasing prevalence of stroke and it...

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