FEATURED ARTICLES

Adaptive Seamless Design For Phase 2/3 Studies: Basic Concepts & Considerations
Adaptive Seamless Design For Phase 2/3 Studies: Basic Concepts & Considerations

An adaptive design is a design that allows for modifications to the processes and statistical procedures of a clinical trial, usually at set intervals established in the trial protocol. Adaptive designs are useful for increasing efficiency and lowering costs associated with clinical research. Studies incorporating adaptive design techniques can be useful in redirecting subject allocation to concentrate on the most promising treatments or in stopping a trial early for futility. The temporal and monetary savings resulting from adaptive designs make them of great value in drug and medical device development.

  • A Practical Framework For Assessing Risk In Clinical Trials
    A Practical Framework For Assessing Risk In Clinical Trials

    The purpose of a comprehensive assessment system is to support structured, systematic, objective, and rational decision making. This holds true even when assessing something as difficult to pin down as risk. 

  • Ensure A Smooth Start-Up In Gene Therapy Trials
    Ensure A Smooth Start-Up In Gene Therapy Trials

    Preparations for a large Phase 3 clinical trial will always present challenges. In the area of gene therapies, those challenges can be magnified. Gene therapy trials can add more time and cost to a trial, and will also require specific expertise not needed in small molecule and biologics trials.

  • Are You Properly Engaging Your Clinical Pharmacology Team?
    Are You Properly Engaging Your Clinical Pharmacology Team?

    Robert Homolka, Director of Clinical Pharmacology Operations at Shire, feels the support the Clinical Pharmacology group provides to the clinical development programs is one of the more important aspects of his job. Studying and ensuring the safety of a drug is of primary importance to the sponsor, and clinical pharmacology is front-and-center in leading that effort.

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WHITE PAPERS & CASE STUDIES

  • Optimize Clinical Trial Success by Reducing the Number of Patients Lost to Follow-Up

    Avoid study delays, increased patient costs, and compromised study data with Bioclinica's program that swiftly and efficiently locates patients who are lost to follow-up, following all privacy and compliance guidelines.

  • Latin America: An Untapped Clinical Trials Resource

    Understand the benefits and challenges of conducting studies in Latin America in addition to some recent changes that could expedite regulatory timelines.

  • Why Choose a Site Network for Your Clinical Trials?

    How global site networks can effectively address timeline, budget and data quality concerns, by providing access to multiple experienced sites within a single network, providing cost savings through reduction of the total number of sites used and recruitment of a large volume of patients.

  • Implementing Patient-Centric Principles in Asthma Research

    Change the perception of clinical trials by making them less burdensome for patients overall.

  • Full Service Porfolio: Early Phase To Commercialization

    ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 97 locations in 38 countries and has approximately 13,100 employees.

  • The Cure For The Common CRO – Introducing The Worldwide Way

    To be successful, your molecule deserves unparalleled experience in Alzheimer’s Disease clinical research. You need a research partner with an uncommon understanding of the complexities associated with evaluating patients with various phenotypes and the ability to implement specific design features to mitigate the risks and challenges specific to Alzheimer’s studies.

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SERVICES & PRODUCTS

Worldwide Clinical Trials Respiratory Disorders Overview Worldwide Clinical Trials Respiratory Disorders Overview

Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-inhuman through phase IV studies. Grounded in medicine and science, Worldwide Clinical Trials enables sponsors to move from medical discovery into clinical development and commercialization, helping bring innovative solutions to market that deliver enhanced value and improve patient lives. Our employees are among the best in their fields – clinicians, scientists, operational and regulatory specialists who offer expertise across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune mediated inflammatory disorders (IMID), and rare diseases.

Worldwide Clinical Trials Rare Disease Overview Worldwide Clinical Trials Rare Disease Overview

Founded by physicians committed to advancing medical science, Worldwide is out to change how the world sees CROs – in the best possible way. From Early Phase and Bioanalytical Sciences through Late Phase and post approval, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO.

Worldwide Clinical Trials Psychiatry Overview Worldwide Clinical Trials Psychiatry Overview

Worldwide Clinical Trials is the leader in CNS clinical research. Our tradition of excellence is founded on therapeutic expertise in CNS disorders, especially psychiatry.

Worldwide Clinical Trials Parkinson’s Disease Overview Worldwide Clinical Trials Parkinson’s Disease Overview

Worldwide’s tradition of excellence is centered on CNS therapeutic expertise and in particular in neurodegenerative disorders such as Parkinson’s disease. Our unparalleled experience in this area allows us not only to understand the complexities associated with Parkinson’s study design, but also to operationally implement specific design features through the use of innovative strategies and tools that mitigate risks and challenges inherent in this type of study.

Worldwide Clinical Trials Analgesia And Pain Overview Worldwide Clinical Trials Analgesia And Pain Overview

Worldwide has extensive capabilities in global analgesia research, including experience with human experimental and clinical models for proof-of-concept in nociceptive and neuropathic pain and for registration studies to support marketing authorization in a number of acute and chronic pain indications.

Worldwide Clinical Trials Neurology Portfolio Worldwide Clinical Trials Neurology Portfolio

Worldwide Clinical Trials takes pride in bringing a depth of knowledge to your study based on experience in trials across a range of neurologic disorders. Our clinical experience enables us to work with you at any stage of drug development from Phase I through Phase IV for traditional, as well as, highly innovative clinical targets. Worldwide has participated in the design, execution, or analysis of 105 trials, over 550 sites and 2,840 patients since 2008. Of the 105 total trials, 55 studies have included at least clinical monitoring or project management. A majority of these studies have been conducted globally including unique capabilities in Russia, Ukraine and Eastern Europe.

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NEWS

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