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Merck’s Patient-Centric Clinical Trial Recruiting MERCK’S PATIENT-CENTRIC CLINICAL TRIAL RECRUITING

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Mar 04, 2020

Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed h...

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What are the main challenges facing the pharmaceutical industry? WHAT ARE THE MAIN CHALLENGES FACING THE PHARMACEUTICAL INDUSTRY?

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Jul 18, 2019

Major issues facing the pharmaceutical industry and their relationship to clinical pharmacy. There are two major issues that have potential for positive interactions between the industry and clinical pharmacy. These are drug selection and reimbursement, and clinical research.

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5 Ways Clinical Research Can Help You and Your Practice 5 WAYS CLINICAL RESEARCH CAN HELP YOU AND YOUR PRACTICE

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Jun 21, 2019

Conducting clinical trials in one’s private practice—as opposed to hospitals or universities—has become more customary in clinical research. This trend is resulting in patients feeling more comfortable with participating in trials and is also providing physicians with unique benefi...

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Matoke Pharma and antimicrobial resistance MATOKE PHARMA AND ANTIMICROBIAL RESISTANCE

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May 29, 2019

Alan joined Matoke Pharma last year, having previous spent 35 years at Bayer, and he explained how that part of his career unfolded, from sales rep to antibiotics clinical research and then to global marketing and brand manager roles before ending with a series of senior management positions.

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Taking Immune Monitoring to a Whole New Level TAKING IMMUNE MONITORING TO A WHOLE NEW LEVEL

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Feb 27, 2019

In 2018, there were approximately 3,400 active agents in the immuno-oncology pipeline, a 67% increase from 2017. Clinical research in the field of immunotherapies is steadily increasing, especially in the area of oncology. The growing interest in immuno-oncology therapies is also reflected in its bo...

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How to Balance Pharma Sales Quotas with a Great Patient Experience HOW TO BALANCE PHARMA SALES QUOTAS WITH A GREAT PATIENT EXPERIENCE

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Dec 31, 2018

Successful pharma sales reps serve as educators, advisers, and trusted colleagues all rolled into one. Pharma 3.0 reps must not only excel at sales, but also read up on clinical research, stay abreast of changing rules and regulations, network with physicians and arrange appointments, and keep track...

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Multi-omics in Cancer Research MULTI-OMICS IN CANCER RESEARCH

whitepaper

Dec 10, 2018

The genome has given clinical researchers a powerful tool for understanding the biological foundations of many diseases, but it only tells part of the story. This ebook shows how different laboratories are employing mass spectrometry and other cutting-edge tools to collect richer datasets based on a...

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Researchers Investigate Drug to Help Veterans With PTSD Sleep Better At Night RESEARCHERS INVESTIGATE DRUG TO HELP VETERANS WITH PTSD SLEEP BETTER AT NIGHT

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Jul 06, 2018

A study into whether or not a new investigational drug could help veterans cope with trauma-related sleep disturbances is in its final phase of clinical research.Started this past January by Tonix Pharmaceuticals, the HONOR study is investigating the effectiveness of new medication intended to help ...

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A Recent History of Antibiotics and Where We May Be Going A RECENT HISTORY OF ANTIBIOTICS AND WHERE WE MAY BE GOING

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Mar 01, 2018

About Clinical Research Management, Inc. Clinical Research Management (ClinicalRM) is not only involved in the testing of new antibiotics in Phase I, II, III studies, monitoring protocol development, site selection, and assistance with FDA approvals, but is also involved in responding to the challen...

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Why you should work for a pharma start-up WHY YOU SHOULD WORK FOR A PHARMA START-UP

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Jan 04, 2018

If we look at Aerie Pharmaceuticals and their new products Rhopressa and Roclatan, these are designed to reduce elevated intraocular pressure (IOP), the cause of vision loss in open-angle glaucoma. This is the largest prescription market in ophthalmology and it’s amazing to see such a breakthr...

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A Practical Approach to the Challenges of Pediatric Drug Development A PRACTICAL APPROACH TO THE CHALLENGES OF PEDIATRIC DRUG DEVELOPMENT

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Nov 17, 2017

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges ...

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Avoiding the Risks of Being Wrong in Drug Discovery AVOIDING THE RISKS OF BEING WRONG IN DRUG DISCOVERY

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May 05, 2017

In a recent case study featuring a mid-market biopharma company, a pre-clinical research leader explains that in order to avoid the risks of being wrong when investigating potential new molecules and validating methods he needs reliable, up to date and comprehensive scientific information.

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Phase I Clinical Trials: The Role of Pharmacy in an Early Phase Clinical Research Unit – Part 2 PHASE I CLINICAL TRIALS: THE ROLE OF PHARMACY IN AN EARLY PHASE CLINICAL RESEARCH UNIT – PART 2

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Apr 13, 2017

Following on from part 1 of our series on the role of pharmacy in clinical research units (CRUs) this post provides valuable insights into the role of manufacturing and compounding, investigational drug blinding and dispending and dosing.

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Phase I Clinical Trials: The Role of Pharmacy in an Early Phase Clinical Research Unit – Part 1 PHASE I CLINICAL TRIALS: THE ROLE OF PHARMACY IN AN EARLY PHASE CLINICAL RESEARCH UNIT – PART 1

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Apr 10, 2017

Phase I clinical trials form an important foundation for drug development and eventual approval of life-saving therapies. This two-part blog will review the role of the pharmacy in a state-of-the-art Phase I clinical research unit (CRU) and discuss best practices.

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Rapid Release of Safer Drugs for MDR Tuberculosis RAPID RELEASE OF SAFER DRUGS FOR MDR TUBERCULOSIS

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Mar 27, 2017

Jing Bao of the Tuberculosis Clinical Research Branch, Division of AIDS/NIAID/NIH, USA, delivers a quick talk at the Uppsala Forum 2016. This talk was part of a series on Pharmacovigilance’s role in rapid access to safer drugs. Bao looks at the two main drugs used to treat Tuberculosis, Bedaquiline ...

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The Making of a CDISC Trainer THE MAKING OF A CDISC TRAINER

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Feb 06, 2017

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’. The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are in...

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New Frontiers in Drug Discovery: Applying CRISPR/Cas9 Genome Engineering to the Drug Pipeline NEW FRONTIERS IN DRUG DISCOVERY: APPLYING CRISPR/CAS9 GENOME ENGINEERING TO THE DRUG PIPELINE

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Jan 26, 2017

For clinical researchers, drug development in a long and arduous process. Though thousands of compounds may be screened to determine their therapeutic potential.

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Diet-Drug-Related Cardiac Valve Disease: Surveillance Methods for Obesity Clinical Research DIET-DRUG-RELATED CARDIAC VALVE DISEASE: SURVEILLANCE METHODS FOR OBESITY CLINICAL RESEARCH

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Jan 23, 2017

Prevalence of obesity has reached and surpassed epidemic proportions, with trends in cardiovascular risk factors such as hypertension, hyperlipidemia, and diabetes, rising in parallel leading to an excess of cardiovascular events.

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Inside PAREXEL: Genomic Medicine INSIDE PAREXEL: GENOMIC MEDICINE

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Nov 01, 2016

PAREXEL’s Anita Nelsen explains how the influence of genomic and pharmacogenomics information in clinical research helps make better drugs and gets those drugs to the right patients.

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UNDER-REPORTING OF ADVERSE DRUG EFFECTS IN CLINICAL RESEARCH UNDER-REPORTING OF ADVERSE DRUG EFFECTS IN CLINICAL RESEARCH

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Oct 30, 2016

Reporting of adverse drug effects (ADE) represents one of the very crucial aspects in clinical research. Appropriate documentation and sufficient information about any such effect or reaction can make a huge difference in terms of patients’ safety and quality of pharmaceuticals which have been teste...

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Medical Writing Services Quanticate MEDICAL WRITING SERVICES QUANTICATE

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Oct 26, 2016

An overview of Medical Writing Services by Quanticate. As a Data Focused Clinical Research Organization we provide regulatory and clinical writing as well as scientific communications support.

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Medpace Bioanalytical in Drug Development MEDPACE BIOANALYTICAL IN DRUG DEVELOPMENT

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Sep 29, 2016

As a full service, global Clinical Research Organization (CRO), Medpace sees itself as a steward of your drug, leveraging its extensive medical and regulatory expertise to deliver additional input, strategy.

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Medpace Clinical Pharmacology Unit MEDPACE CLINICAL PHARMACOLOGY UNIT

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Sep 27, 2016

Medpace Clinical Pharmacology Unit (CPU) is dedicated to the conduct of early-phase clinical pharmacology studies in normal healthy volunteers, special populations, and patient populations over a spectrum of diseases. Medpace CPU is a fully owned subsidiary of Medpace, Inc. An expanded state-of-the-...

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2nd pharmacovigilance 2016 2ND PHARMACOVIGILANCE 2016

whitepaper

Jul 12, 2016

RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage point in the contemporary pharma industry by ingra...

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Pharmacists and Clinical Trials PHARMACISTS AND CLINICAL TRIALS

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May 20, 2016

Today is International Clinical Trials Day (ICTD). Now in its 11th year, ICTD is celebrated around the world to commemorate the day James Lind started his famous clinical trial on scurvy. The day is an opportunity for organisations and clinical research professionals to discuss the benefits that inv...

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WHAT ARE THE KEY FACTORS FOR CHOOSING THE BEST TRAINING PROVIDER IN THE PHARMA AND CLINICAL RESEARCH INDUSTRY? WHAT ARE THE KEY FACTORS FOR CHOOSING THE BEST TRAINING PROVIDER IN THE PHARMA AND CLINICAL RESEARCH INDUSTRY?

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Apr 06, 2016

A company is truly alive and functional not only when it has qualified personnel that triggers productivity but when it has returning clients as well. Yet, a company truly survives and grows when it offers satisfying services.

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Clinical trials – a rigorous framework for trial authorisation and patient safety monitoring CLINICAL TRIALS – A RIGOROUS FRAMEWORK FOR TRIAL AUTHORISATION AND PATIENT SAFETY MONITORING

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Feb 26, 2016

Medicine development takes an average of 12 years until approval for use in patients. Clinical research is an essential part of the development process but it is also the lengthiest and most expensive.

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IPPCR 2016: Concepts in Pharmaceutical Development Project Management IPPCR 2016: CONCEPTS IN PHARMACEUTICAL DEVELOPMENT PROJECT MANAGEMENT

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Feb 04, 2016

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protoc...

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PAREXEL - Roland Andersson, SVP, Discusses Investing Trends and Emerging Biopharmaceutical Companies PAREXEL - ROLAND ANDERSSON, SVP, DISCUSSES INVESTING TRENDS AND EMERGING BIOPHARMACEUTICAL COMPANIES

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May 18, 2015

PAREXEL helps position emerging Biopharmaceutical companies by providing them with advice and capabilities. We provide them with advice regarding clinical research strategies, regulatory strategies, as well as expedited approval pathways, to give a few examples.

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European Perspective for Effective Cancer Drug Development and New Forms of Partnerships for Managing Uncertainty EUROPEAN PERSPECTIVE FOR EFFECTIVE CANCER DRUG DEVELOPMENT AND NEW FORMS OF PARTNERSHIPS FOR MANAGING UNCERTAINTY

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Mar 12, 2015

The aims of the European Organisation for Research and Treatment of Cancer (EORTC) are to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patient quality of life.

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Early Stage Clinical Research at Algorithme Pharma EARLY STAGE CLINICAL RESEARCH AT ALGORITHME PHARMA

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Aug 08, 2013

Our goal is to provide the best quality early stage clinical development services to an international customer base of biotechnology and pharmaceutical companies with a focus on customer servic.

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ICON Clinical Research - Medical and Safety Services ICON CLINICAL RESEARCH - MEDICAL AND SAFETY SERVICES

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Apr 05, 2012

Marcin Wlodarczyk, ICON's VP Medical & Saftey Services outlines ICON's Medical Offering

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Serious Safety Problems Involving the FDA and the Pharmaceutical Industry SERIOUS SAFETY PROBLEMS INVOLVING THE FDA AND THE PHARMACEUTICAL INDUSTRY

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May 17, 2010

As part of the Duke University School of Medicine, the Duke Clinical Research Institute is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research.

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Clinical research white paper CLINICAL RESEARCH WHITE PAPER

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The evolution from scientific hypothesis to approved and marketed medicine is a lengthy and arduous process that typically spans many years of research and development. to understand clinical research and data flows.

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Clinical Research Coordinator Industry Perspective CLINICAL RESEARCH COORDINATOR INDUSTRY PERSPECTIVE

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CRCs are the main liaison between investigators and studyparticipants, and between the site and the sponsor; they also manage the study activity of clinical sites.

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QA Q&A: How Quality Management Systems are Evolving to Support Personalized Medicine QA Q&A: HOW QUALITY MANAGEMENT SYSTEMS ARE EVOLVING TO SUPPORT PERSONALIZED MEDICINE

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In my experience, companies such as clinical research organizations (CROs) must be founded on a flexible, proactive, risk-based Quality Management System (QMS) to ensure the proactive identification of important risks, promote data-driven quality deliverables, and facilitate process improvements thr...

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Medicine MEDICINE'S NEXT REVOLUTION | ALAN CASSELS | TEDXVICTORIA

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A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical ...

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SPOTLIGHT

The PSA (prostate-specific antigen) test, also called PSA screening, evaluates a blood sample for elevated levels of the prostate-specific antigen. PSA is a protein that can indicate the presence of cancer in the prostate, which is a small gland below the bladder.

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