Featured Articles

  1. 4 Types Of Efficacy Outcomes To Consider In Phase II Clinical Trials 8/28/2014

    You will often hear the phrase “learn and confirm” related to clinical trials. Phase II clinical trials are where you “learn” about your treatment and phase III clinical trials are where you “confirm” what you know for regulatory agencies. By Dr. Karen Kesler and Dr. Andrea Mospan

  2. 4 Tips For Planning The RFP Process For Clinical Trial Services 8/28/2014

    Before you request bids from contract research organizations (CROs) for clinical trial services, it’s important to spend time planning your request for proposal (RFP) process. By Jamie Hahn

  3. 3 Key Questions When Developing The Integrated Summary Of Safety (ISS) 8/28/2014

    A New Drug Application (NDA) covers information about a product from inception through clinical trials. The integrated summary of safety (ISS) is a section of the NDA that provides comprehensive safety information collected throughout the development program. By Rob Woolson

  4. Choosing The Right System For Your Clinical Trial: The Differences Between EDC And IVR/IWR 8/28/2014

    Sometimes it’s difficult to determine the best tool for a job, especially when technologies are developed in parallel to handle similar tasks. Take Interactive Response Technology (IxR) and Electronic Data Capture / Electronic Case Report Forms (EDC), for example. By Steve Palmatier

  5. 6 Tips For An Effective Kick-Off Meeting For A Clinical Trial 8/28/2014

    Kick-off meetings happen routinely at the start of a new clinical trial. Often, they fail to offer participants the information they need or to engage project team members in a way that helps them retain key information. 

  6. 5 Challenges In Site/CRO Relationships 8/28/2014

    Strong Working Relationships between clinical trials sites and the CRO managing the study are critical to successfully executing a clinical trial. 

  7. 5 Tips For Creating A Request For Proposal (RFP) For Clinical Trial Services 8/28/2014

    If you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). By Jamie Hahn

  8. 5 Things You Should Know About Phase 1 Clinical Trials 8/28/2014

    Preclinical studies, including both in vitro and animal studies provide valuable information and are the foundation for designing for “First in Man” phase 1 studies, but the results are rarely directly transferrable for humans.

  9. Considerations For Development And Approval Of Analgesic Products 7/31/2014

    The regulatory landscape for the development and approval of analgesic products has a well-documented history in the literature and the regulatory annals for these extremely important therapeutic compounds. Current products range from the frequently administered non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of acute pain, osteoarthritis and other sensory/nociceptive pain to the controlled opioids, Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors (SSRIs/SNRIs), and gamma-Aminobutyric acid (GABA) analogues that relieve pain of a more chronic and neuropathic nature. By David Shoemaker, Senior Vice President, Research and Development, Rho

  10. The Minimal Clinically Important Difference In Efficacy Trials Of Analgesics 7/31/2014

    The objective of analgesic medication is to relieve discomfort and ameliorate the patient’s dissatisfaction with his/her overall clinical state related to pain. Because pain can be perceived only by the patients/subjects themselves, subjective patient reports are the only measures of pain intensity currently available. By Dr. Brian Boehlecke, Medical Officer, Rho