WHITE PAPERS & CASE STUDIES
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Cardio-Metabolic: Clinical Development and Consultative Services
PRA Health Sciences (PRA) provides comprehensive clinical development and consultative services to support our clients’ cardio-metabolic studies.
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Cutting-Edge Analytics Transform Global Cardiovascular Post-Marketing Commitment
A global real world safety study program, mandated by various regulatory bodies, to confirm risk/benefit profile for a novel oral anticoagulant.
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Rare Diseases Clinical Trial Services
Clinical development involving rare diseases poses a unique set of medical, scientific, and operational challenges.
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The Environmental Impact of Clinical Trials
For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.
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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.
SERVICES & PRODUCTS
Writers with both industry and therapeutic expertise
Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.
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NEWS
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Nine New Analyses Show Novartis’ LCZ696 Could Change Course Of Heart Failure For Patients
New data on Novartis’ investigational medicine, LCZ696, for patients with heart failure with reduced ejection fraction (HFrEF) shows it has the potential to change the course of the disease for patients.1,2 In August 2014, Novartis presented topline results from the landmark PARADIGM-HF study showing LCZ696 was superior to ACE inhibitor enalapril on key endpoints, including significantly reducing the risk of cardiovascular (CV) death or heart failure hospitalization.5
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Isis Initiates Phase 1 Study Of ISIS-APOA Rx To Treat Atherosclerosis
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOARx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis.
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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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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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Isis Pharmaceuticals Initiates Phase 2 Study Of ISIS-CRP Rx In Patients With Atrial Fibrillation
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced the initiation of a Phase 2 study evaluating ISIS-CRPRx in patients with paroxysmal atrial fibrillation.
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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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Portola And Lee's Pharmaceutical Enter Into Agreement To Expand Phase 3 APEX Study Of Betrixaban Into China
Portola Pharmaceuticals, Inc. and Lee's Pharmaceutical (HK) Ltd. (
HKSE : 0950) today announced an agreement to jointly expand the Phase 3 APEX study of betrixaban into China, with an option for Lee's to negotiate for the commercial rights to the drug in China. -
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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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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Demographics Favoring Growth Of Cardiac Imaging Modalities Market
Manufacturers to focus on innovative, easy-to-use and patient-friendly products due to a shift in the adoption pattern for imaging modalities.
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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.
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Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate.
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Arena Pharmaceuticals Initiates Phase 1 Multiple Dose Clinical Trial Of APD811 For Pulmonary Arterial Hypertension
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).