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  • 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

  • MedImmune’s Blueprint For Building A Biologics R&D Engine
    MedImmune’s Blueprint For Building A Biologics R&D Engine

    Bahija Jallal, VP of translational science for MedImmune, has some insights on how to successfully focus your biologics R&D operation to encourage, not kill the entrepreneurial spirit on which it was built.

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  • 33 Questions To Ask Before Buying Data Management Software

    While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.

  • Signature Requirements For The eTMF
    Signature Requirements For The eTMF

    Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.

  • Identifying Products For Drug Development Programs

    Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources.

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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.

Adverse Event Management Adverse Event Management

At Sentrx, we run the gamut, covering every aspect of pharmacovigilance for all stages of development and all sizes of clients. Whether your circumstances are more heavily influenced by clinical needs or post-marketing surveillance requirements or you are examining drug safety as part of your New Drug Application planning or preparing to implement risk mitigation strategies, Sentrx has the expertise to make your drug safety operations more flexible, cost-effective, and efficient.

Special Populations: Renal And Hepatic Impairment Special Populations: Renal And Hepatic Impairment
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.
DESI (Drug Efficacy Study Implementation) Drugs Approval DESI (Drug Efficacy Study Implementation) Drugs Approval
Camargo will work with you to prepare a comprehensive plan to secure approval for DESI (Drug Efficacy Study Implementation) drugs.
505(b)(2): Is it for you? 505(b)(2): Is it for you?
A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant.
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