Application Notes & Case Studies

  1. Fully Integrated And Validated ePRO/EDC Solution

    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.

  2. Cost Efficiency And Committed Team

    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.

  3. Making Smart Protocol Decisions For Clinical Study Samples

    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.

  4. DNA Therapy RAC Submission And IND Application

    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.

  5. CDISC Conversion In Oncology Clinical Trial

    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.

  6. Treating Cystic Fibrosis: An Evaluation Of An Aerosolized Form Of Levofloxacin

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

  7. MedicINova Changes CROs During Phase II Asthma Trial

    SynteractHCR, Inc. was sought out by sponsor MediciNova, a publicly traded biopharmaceutical company headquartered in San Diego, for assistance on a Phase 2 asthma trial, MN-221 Cl-007: A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MN-221 in adults with acute exacerbations of asthma.

  8. Automated Workflows Increase Productivity

    Using automated workflows that track process steps and completion dates results in better communication, increased productivity, simplified data gathering, and enhanced visibility to study startup status.

  9. Activate Reduces Cycle Times
    Removing guesswork from the study startup process and proactively using role-based handoffs to identify bottlenecks leads to greater efficiency and reduced cycle times.
  10. Purpose-Built Tools Shorten Study Startup Time

    Using purpose-built tools to track and manage document exchanges and other study startup tasks results in reduced activation times.