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FEATURED ARTICLES

Proposed Tax Change Would Impact Clinical Research
Proposed Tax Change Would Impact Clinical Research

Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.

  • Can Exco InTouch Bring Added Value To Oracle’s InForm?
    Can Exco InTouch Bring Added Value To Oracle’s InForm?

    Oracle and Exco InTouch announced a partnering agreement that will integrate Exco InTouch’s ePRO patient engagement platform with Oracle Health Sciences’ InForm electronic data capture (EDC) system. The combination of the two platforms is expected to deliver enhanced workflow efficiency in clinical trials. But is the partnership truly a win for both companies?

  • After Government Debacle, Is It Any Easier To Perform Clinical Trials In India?
    After Government Debacle, Is It Any Easier To Perform Clinical Trials In India?

    In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?

  • France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results
    France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results

    The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.   

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WHITE PAPERS AND CASE STUDIES

  • SynteractHCR Full-Service CRO Brochure

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  • Is Your Biobank Ready For The Challenge Of Biomarker-Based Research?

    In this whitepaper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery. By Mark A Collins Ph.D., BioFortis, Inc.

  • Phase II Primary Insomnia Program In Need Of Full-Service CRO Management

    Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.

  • ICON Clinical Development Overview

    ICON is one of the world’s largest providers of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies.

  • Special Populations: Renal And Hepatic Impairment Datasheet

    ICON’s experience supporting early phase studies in subjects with renal and hepatic impairment, as well as our close contact with local IRBs, allows our team to expedite study start-up project activities and meet enrollment objectives.

  • Early-Phase Metabolic Development Datasheet ICON’s consultancy services advise on clinical pharmacology study designs based on preclinical data – including potential use of surrogate markers and pharmacodynamic models, validation of those markers and models, clear objective setting and flexible protocol design.
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SERVICES AND PRODUCTS

Biostatistical Services Biostatistical Services

Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

Outcomes Research Outcomes Research

ICON Late Phase and Outcomes Research deliver strategic expertise, high-impact evidence that explores and demonstrates value of healthcare products and meets the demands of the global and national markets for patient reported outcome services.

Biostatistics Biostatistics

ICON provides biostatistic services for clinical development plans, study design, statistical analyses, and regulatory support.

Data Management Data Management
We have extensive data management, biostatistics and clinical programming expertise in migration and integration of data from multiple sources across a large number of therapeutic areas.
Data Sciences Data Sciences
PAREXEL's team of data sciences experts offers available resources from over 650 professionals worldwide, with the capability to work together as one on the same clinical database.
Clinical Services Clinical Services

In today’s pressure-filled biopharmaceutical development environment, no company can afford to spend the $800M or more it takes to bring a product from the lab to the marketplace, only to have it fail in critical Phase III clinical trials.

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NEWS

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