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 & CASE STUDIES

  • Regulatory Approval Of Clinical Studies In The Netherlands

    The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

  • Human ADME & Studies With Radiolabeled Compounds

    During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences

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