Does Your Clinical VP Have The Right Aptitude And Attitude?
Does Your Clinical VP Have The Right Aptitude And Attitude?

For a small biotech company, making the transition from discovery to clinical is where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time, no position will be more important than your director of clinical development.

  • Rare Diseases Require Unique Approaches In Clinical Trial Design
    Rare Diseases Require Unique Approaches In Clinical Trial Design

    The vast majority of rare diseases have no approved treatments available, despite the fact that research related to these diseases has expanded significantly in the past 20 years. A key reason may be the many unique challenges researchers face when developing drugs to treat rare diseases, including difficulties designing and executing effective and appropriate clinical trials.

  • 4 Types Of Dose Finding Studies Used In Phase II Clinical Trials
    4 Types Of Dose Finding Studies Used In Phase II Clinical Trials

    While there are a number of strategies to determine the optimal dose, gain a better understanding of the four most common dose finding study designs.

  • AMO Pharma Addresses Rare Childhood Disease
    AMO Pharma Addresses Rare Childhood Disease

    “Rare diseases are bad enough, but the ones that affect children are even more heartbreaking,” says Mike Snape, CEO of AMO Pharma, a virtual biotech focused on rare disease. “The medical need in these areas is greater than ever. They also present challenges for drug developers, especially with clinical trials.”

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  • Confronting The Challenges Of Rare Disease: Finding Solutions Across The Entire Product Life Cycle

    A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.

  • Applications For Genomic Technologies In Immuno-oncology

    Genomic- based biomarkers are powerful tools used to assess tumor mutational burden, production of novel or neo- antigens and hallmarks of genomic instability, which may be useful as measures of response or resistance to immune therapies.

  • 10-Step Commercial Clinical Protocol Authoring Guide

    Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

  • What The Fitbit Is Helping Pharma Learn About Patients

    Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

  • End-To-End Management Of Clinical Trials Data

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.

  • Moving Towards An Electronic Environment In Clinical Trials

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

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Pathways To Improved Patient And Prescriber Experiences Pathways To Improved Patient And Prescriber Experiences

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Optimizer: Clinical Supply Chain Planning Technology Optimizer: Clinical Supply Chain Planning Technology

Optimizer is BioClinica's powerful forecasting and demand planning technology used by the world's largest pharmaceutical companies to manage global logistics of the clinical supply chain. Managing supplies based on demand creates opportunities for savings and efficiencies in numerous areas, eliminating the high cost of waste as well as shortages that threaten timelines, budgets and even study integrity.

UX Trial Design™ - Unified Design Tool UX Trial Design™ - Unified Design Tool

DATATRAK ONE® UX Trial Design™ product streamlines the entire design-to-deployment process using a single tool. Trial Designers are able to configure their studies, immediately view their changes in the Design environment and commit the files into the versioning repository.

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We deliver superior service through our DATATRAK ONE® program by aligning our service delivery processes and our integrated technology.

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ICON Medical Imaging’s use of superior technology, advanced science and experienced people lead to the ultimate goal: results.

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