Application Notes & Case Studies

  1. Phase III Trial: Building Flexibility Into Standard Dispensing Rules And Visit Schedule
    4/1/2016

    The sponsor needed to know if almac clinical technologies’ ixrs could accomodate certain deviations to the standard dispensing rules and visit schedule. 

  2. EDC Made Intuitive And User-Friendly
    3/31/2016

    EO2 Concepts is an advanced wound care technology company. The company develops and commercializes electrochemical low-dose tissue oxygenation and wound monitoring systems. Their flagship product, TransCu O2®, is an FDA cleared Class III medical device intended to treat difficult to heal wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers.

  3. 50% Savings On Post Marketing Studies
    3/31/2016

    Intuitive Surgical, worldwide leading technology medical device company, was expanding the use of their number one medical device to new therapeutic areas. It counts over 1,670 surgical systems installed in over 1,500 hospitals. This post-marketing study was key to show how their surgical robot could benefit other types of surgery. The sponsor was looking for a way to efficiently manage such large amounts of data while staying on time and on budget.

  4. Providence Medical Technology Chooses ClinCapture To Collect Data Quickly And Accurately
    3/24/2016

    Providence Medical Technology, a fast-growing medical device company with its headquarters in Lafayette, CA, was seeking a rapid and accurate method to collect data for its retrospective observational clinical study.

  5. Fully Integrated And Validated ePRO/EDC Solution
    3/24/2016

    A pharmaceutical company develops and commercializes innovative targeted oncology treatments to address major unmet medical needs and advance cancer care. Founded in 2006 and headquartered in Portland, Oregon, this company is pioneering research in the field with several drugs in the pipeline, one of which is already FDA approved.

  6. Cost Efficiency And Committed Team
    3/24/2016

    Sequenom is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. The medical device company, founded in 1994 and headquartered in San Diego, CA, develops innovative technologies, products, and diagnostic tests that target and serve discovery, clinical research, and molecular diagnostic markets.

  7. Making Smart Protocol Decisions For Clinical Study Samples
    3/23/2016

    Logistics can be one of the most complex aspects of successful clinical trials because samples shipped from study sites for testing at a central laboratory must be maintained within a very limited temperature range.  Cold chain or refrigerated logistics, where temperature is controlled in the shipping environment, often brings added challenges and expense.  LabConnect provides validated cold-chain solutions, however controlled ambient shipping solutions are becoming more important in cases where whole blood samples are required by the testing laboratories.  This is seen most readily in PBMC and other analyses where high cellular viability and yields are critical.

  8. DNA Therapy RAC Submission And IND Application
    3/4/2016

    In January 2013, SynteractHCR began working with Tacere Therapeutics (A Benitec Biopharma company) to prepare for an NIH Recombinant DNA Advisory Committee (RAC) meeting prior to submitting an Investigational New Drug (IND) application to the FDA for its TT-034 Hepatitis C therapy.

  9. CDISC Conversion In Oncology Clinical Trial
    3/4/2016

    Often, early-development stage companies are working on pharmaceuticals and medical devices that have promising clinical intellectual property and commercial prospects. They may even have large pharma partners that help with financing and, eventually, submissions around the world. But in the beginning of trial phases they are often working with shoe-string budgets and simply trying to see if the innovative product will be efficacious.

  10. Treating Cystic Fibrosis: An Evaluation Of An Aerosolized Form Of Levofloxacin
    3/4/2016

    SynteractHCR is a privately held contract research organization (CRO) dedicated to meeting the needs of biotech, pharmaceutical and medical device companies.