Safety/Efficacy White Papers & 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. Critical Success Factors For Clinical Trials Of Immune Checkpoint Inhibitors 3/4/2016

    Oncologists and their patients have had reason recently to be encouraged by the launch of immune checkpoint inhibitors (ICIs) for the treatment of several difficult-to-treat diseases, including metastatic melanoma and non-small cell lung cancer. These novel agents activate the human immune response against antigens expressed on tumor cells, and the science has generated excitement among physicians, patients, the media and researchers.

  3. InVentiv Health Late Stage Research Datasheet 3/4/2016

    In today’s competitive landscape, getting a drug on the market is no longer about meeting clinical trial requirements, receiving regulatory approval and launching the drug. Drug developers need to generate evidence that shows whether a drug works in the real world and the benefit and value it provides to the healthcare system and patient.

  4. SynteractHCR Full-Service CRO Brochure 3/4/2016

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  5. What The Fitbit Is Helping Pharma Learn About Patients 2/22/2016

    Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.

  6. Regulatory Approval Of Clinical Studies In The Netherlands 5/16/2013

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

  7. Global Biosimilar Development 5/16/2013

    Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products.

  8. End-To-End Management Of Clinical Trials Data 5/16/2013

    The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.

  9. Future Trends For Online EDC In Clinical Studies: INTrial© Application On PCs, Tablets and Smartphones 5/15/2013

    The positive effect of electronic data capture (EDC) on the increase of data quality and on the decrease of time to generate clean data is well known. Today the question no longer is “Shall we use EDC instead of paper work?” but to gain insight in the advantages and pitfalls of the various solutions available.

  10. Military Drug Trials Group Eliminates Errors And Inefficiencies Using Electronic Data Capture And Tablet PCs 5/8/2013

    Infectious Disease Clinical Research Program (IDCRP) is a worldwide network of Department of Defense (DoD) clinical and research centers that have collaborated to investigate infectious disease challenges facing the military.