WHITE PAPERS & CASE STUDIES
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Healthcare Company Expects Online Collaboration To Save Millions Of Euros
Sanofi is a multinational pharmaceutical company engaged in the research and development, manufacturing, and marketing of prescription drugs, vaccines, and over-the-counter healthcare products.
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Overcoming Clinical Challenges In Metabolic And Cardiovascular Disease With Metabolomics
Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted.
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Strategic Clinical Outsourcing Considerations: The Interdependency Of Clinical Drivers
A solid outsourcing strategy is critical to leading your organization to a successful outsourcing experience. Of course every organization in need of outsourced services must consider their priorities: Is it cost? Timelines? Team experience? Some combination? Inevitably the salient considerations are a combination of each of these factors, yet some will be weighed more heavily than others. By Kevin Boos, RDP Clinical Outsourcing, Scott Connor, Acurian, and Meenal Patel, RDP Clinical Outsourcing
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Supporting Multiple Registries With A Single System
Registries are created for a wide range of purposes that include such goals as recruiting patients for clinical trials, tracking treatment plans for tumor boards, determining study feasibility, conducting retrospective chart reviews, and evaluating outcomes.
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Optimizing Clinical Trial Enrollment: Same Day Turnaround Of Blood Chemistry For Eligibility
Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. By Paul S. Savuto, MS, MBA Blinded Diagnostics
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Patient Type 2 Diabetes Case Study
ePharmaSolutions, a global study launch and site support services company, trained 50 investigative sites on recruitment best practices, and developed a highly targeted direct mail campaign, both of which yielded results far exceeding already aggressive study timelines.
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NEWS
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Lilly Announces Enzastaurin Phase III Study Did Not Meet Primary Endpoint In Diffuse Large B-Cell Lymphoma
Eli Lilly and Company (NYSE: LLY) announced today Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
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La Jolla Pharmaceutical Company Announces Completion Of Phase 1 Portion Of GCS-100 Clinical Trial In Chronic Kidney Disease
La Jolla Pharmaceutical Company (
OTCBB : LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting galectin proteins, announced today that it has treated the last patient in the Phase 1 (Part A) portion of the Phase 1/2 clinical trial of GCS-100 in patients with chronic kidney disease ("CKD"). -
Catabasis Initiates Phase 1 Trial Of CAT-2003 For Treatment Of Severe Hypertriglyceridemia
Catabasis Pharmaceuticals Inc., today announced the initiation of a Phase 1 study to investigate the safety and tolerability of CAT-2003 in healthy volunteers and in adults with mildly elevated lipids. CAT-2003 is a conjugate of niacin and eicosapentaenoic acid (EPA), an omega-3 fatty acid, covalently linked using the company's proprietary SMART Linker technology to create a new chemical entity and is being developed for patients with severe hypertriglyceridemia.
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Piramal Enterprises’ Diagnostic Division Launches QDx Instacheck
Piramal Enterprises’ diagnostic division recently announced the launch of “QDx Instacheck” Right-here-Right-now.
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Sanofi And Regeneron Report Positive Proof-of-Concept Data For Dupilumab
PARIS and TARRYTOWN, N.Y., March 2, 2013 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.
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CeQur Announces Positive Results From Study Evaluating Simple Insulin Delivery Device Among People With Type 2 Diabetes
CeQur SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that initial data from a study of the company's PaQ® Insulin Delivery Device were presented today at the 6th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France.
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Concert Pharmaceuticals Announces Completion of Enrollment in Phase 2 CTP-499 Clinical Trial
Concert Pharmaceuticals, Inc. announced today that it has completed enrollment of patients in a Phase 2 clinical trial evaluating CTP-499 for the treatment of diabetic kidney disease. CTP-499 is intended to slow progression of kidney damage in diabetic kidney disease and be additive to the current standard of care, which is treatment with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin receptor blocker (ARB). Concert expects to report top-line results from the Phase 2 study during the second-half of 2013.
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FDA Agreement On Mesoblast's Use Of Singapore Manufacturing Facility For Clinical Trial Production Of Proprietary Mesenchymal Precursor Cells
Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
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Gains In Cardiac Rhythm Management Devices Offset By Lower Pricing
The rising incidence of lifestyle diseases such as diabetes and obesity, an ageing population and the prevalence of cardiovascular diseases such as arrhythmia, heart failure and atrial fibrillation, have expanded the patient pool for cardiac rhythm management (CRM) devices in both Europe and the United States.
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DiaMedica Successfully Completes DM-199 cGMP Manufacturing And Pre-Clinical Toxicology Safety Studies
DiaMedica (TSX VENTURE:DMA) has successfully completed cGMP manufacturing of DM-199 to be utilized in upcoming clinical trials.
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Drugs for diabetes: Scientists Test The Power Of Plants
New drugs to treat diabetes are being developed by scientists at the University of Greenwich.
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ActiGraph Launches ActiLife Mobile App
ActiGraph, a leading provider of objective patient monitoring solutions for the global research community, recently announced the release of a new mobile app for researchers.
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Tranzyme Pharma Announces Top-Line Results Of TZP-102 Phase 2b Trial
Tranzyme Pharma (Nasdaq:TZYM), today announced top-line results of the preliminary analysis of the first of two Phase 2b trials assessing the safety and efficacy of its oral ghrelin agonist, TZP-102 in diabetic patients with gastroparesis.
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Zafgen Announces Initiation Of Phase 2a Clinical Development With Beloranib In Obesity
Zafgen, Inc., a leading biopharmaceutical company dedicated to addressing the unmet needs of severely obese patients, today announced that it has initiated Phase 2a clinical testing of beloranib.