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FEATURED ARTICLES

  • Speeding Research With Data Mining Expertise
    Speeding Research With Data Mining Expertise

    According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.

  • How Do I Get My Compound Into Phase I?
    How Do I Get My Compound Into Phase I?

    The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

  • A Chief Scientific Officer’s Opinion On Clinical Outsourcing
    A Chief Scientific Officer’s Opinion On Clinical Outsourcing

    Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.

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WHITE PAPERS AND CASE STUDIES

  • Marketing Application Submission Services Brochure

    Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.

  • Regulatory Approval Of Clinical Studies In The Netherlands
    Regulatory Approval Of Clinical Studies In The Netherlands

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

  • Streamline And Accelerate A Drug Development Plan Using The 505(b)(2) Pathway

    An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.

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SERVICES AND PRODUCTS

Medical & Regulatory Affairs Medical & Regulatory Affairs

Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

Medical Writing Medical Writing

As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.

Marketing Application Submission Services Marketing Application Submission Services

Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.

Clinical Product Safety Clinical Product Safety

Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.

Late Phase Research Late Phase Research

Whether it is comparative effectiveness, outcomes or increasing market penetration, our Late Phase and Outcomes Research Group capitalizes on the expertise of our dedicated Phase IIIb/IV project operations group coupled with our extensive experience in scientific services and outcomes research.  

Medical & Drug Safety Services Medical & Drug Safety Services

ICON’s Medical and Safety Services Group offers safety support across all stages of the product lifecycle by  providing efficient drug safety processes, compiling concise drug safety profiles, and developing tailored risk-management strategies.

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