White Papers

  1. Regulatory Requirements For Medical Devices In China

    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

    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

    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

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

  5. Optimizing Investigator Payments in Clinical Trials Via Effective Business Process Outsourcing

    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

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

  7. Latin America: An Untapped Clinical Trials Resource

    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?

    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

    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?

    - 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