White Papers

  1. Regulatory Requirements For Medical Devices In China
    4/24/2018

    Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.

  2. User Acceptance Testing And RTSM System Validation
    4/19/2018

    When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements. 

  3. Modern Technologies In Clinical Trials
    4/19/2018

    Trial designs are becoming more complex. Most of these trials are supported by legacy/older technologies that have limited flexibility to quickly adapt to new trial information. The pharmaceutical industry is reaching a tipping point, where the need for flexibility is outweighing the need to be conservative and risk-averse in this highly-regulated environment.

  4. Understanding The New ICH-GCP Landscape
    4/17/2018

    Can organizations implement today’s regulatory requirements using conventional approaches?

  5. Optimizing Investigator Payments in Clinical Trials Via Effective Business Process Outsourcing
    4/2/2018

    A full-service, highly qualified partner who uses effective technology-enabled financial management services can help ensure efficient site payments, greater transparency into payments on all sides, and satisfied investigators.

  6. Efficient Use of Resources to Ensure High-Quality Data
    3/27/2018

    How proactive planning to track missing patients will minimize their detrimental effect on study results.

  7. Latin America: An Untapped Clinical Trials Resource
    3/27/2018

    Understand the benefits and challenges of conducting studies in Latin America in addition to some recent changes that could expedite regulatory timelines.

  8. Why Choose a Site Network for Your Clinical Trials?
    3/27/2018

    How global site networks can effectively address timeline, budget and data quality concerns, by providing access to multiple experienced sites within a single network, providing cost savings through reduction of the total number of sites used and recruitment of a large volume of patients.

  9. Implementing Patient-Centric Principles in Asthma Research
    3/21/2018

    Change the perception of clinical trials by making them less burdensome for patients overall.

  10. Can Your Clinical Supply Chain Pass The Brexit Pressure Test?
    3/13/2018

    - Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask