White Papers

  1. Top eClinical Trends Report

    Clinical research is well on its way to transforming its paper-driven model to an all-things-electronic format. This paper focuses on the top eClinical trends in 2015 and 2016. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring.

  2. Critical Success Factors For Clinical Trials Of Immune Checkpoint Inhibitors

    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. The New EU Clinical Trials Regulation: The Good, The Bad, The Ugly

    The time and costs of conducting clinical trials in the European Union grew significantly.

  4. EDC Platforms: What’s Right for You?

    EDC systems are designed to collect clinical trial data directly from clinical sites over a secure web-based connection. Common components of EDC systems include: an administrative console for creating users and managing role-based security, a graphical user interface (GUI) for data entry, a validation engine to execute edit checks and verify the validity of the data entered into the system, a developers’ interface to build the electronic case report forms and program edit checks, and a reporting module providing both standard and ad hoc reporting capabilities and ability to export data. There are a number of EDC systems available.

  5. What The Fitbit Is Helping Pharma Learn About Patients

    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. Pharmacogenomics Is Changing Oncology: 5 Things You Need to Know Now

    This white paper discusses pharmacogenetic testing and presents five things that should be understood about this testing process.

  7. How To Secure Mobile Devices Used In Clinical Trials

    In the foreseeable future, biopharmaceutical companies that do not allow those working on clinical trials to have mobile access to the systems and data they need, will be at a competitive disadvantage. Internal users, investigator sites, Clinical Research Organizations (CROs), central labs, and other vendors all have a growing expectation that they can access trial data and applications “where they live,” in other words, on their mobile devices.

  8. goBalto Activate™ In The ClinOps Ecosystem

    Understanding the technology landscape of SSU optimization and how different tools interact is key to accelerating study startup. Not only does each tool play a distinct role; ensuring they play well together is vital to ensuring faster start times, elimination of redundant work, and more efficient processes.

  9. Using eClinical Systems To Speed Up Clinical Trials

    understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process.

  10. Post-Authorisation Non-Interventional Prospective Observational Safety Studies: Protocol Considerations

    The 2010 EU pharmacovigilance legislation sets out clear provisions in relation to Post-Authorisation Safety Studies (PASS).