White Papers

  1. Accelerating Regulatory Approval For Drugs And Biologics In The US

    The FDA has created four different methods to help speed up the approval of drugs and biologics that can treat serious diseases – Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Fast Track Designation (FTD), and Priority Review (PR).  This white paper provides an overview of these four mechanisms and will help you to understand the requirements and benefits of each.

  2. How To Streamline Your Global Pharmacovigilance Management Process

    This white paper discusses the benefits of moving from tactical to strategic outsourcing on pharmacovigilance, and presents key ways that TransPerfect Life Sciences can help in this endeavor during the development and launch of new products.

  3. 10 Insider Tips For eCOA Implementation

    If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.

  4. Nine Evolutions In Clinical Research And Patient Recruitment

    Many facets of research in clinical trials – particularly where patient recruitment is concerned – are rapidly trending in new directions. This white paper outlines the changes ahead of us and how they’ll impact clinical trials in 2016. Download it to stay up to date and help your organization meet the demands of a rapidly evolving industry.

  5. Risk-Based Monitoring - Can You Afford To Wait?

    On-site monitoring is one of the largest cost drivers in a trial, accounting for 30 percent on average of the cost of a clinical trial. Fifty percent of the cost of on-site monitoring involves ensuring data quality through source document verification (SDV).

  6. The Challenges Of Paper Backups In eCOA Studies

    In the past, a clinical trial’s important study endpoints were captured on paper. Electronic Clinical Outcome Assessments (eCOA) have increased in popularity as a way to capture those same endpoints – whether through a smartphone, tablet, or web and/or app-based systems. This white paper discusses the approach to using paper in this capacity, and highlights its limitations.

  7. Poor Protocol Design Is Costing You More Than Money

    Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials.

  8. Assuring Patient Adoption During Biosimilar Development And Commercialization

    As the most important stakeholder in clinical developments, the patient should be deeply embedded in the clinical trial development process. This white paper explains this concept as it relates to biosimilar drug development – with an emphasis on assuring the patient’s adoption.

  9. CROs And The Clinical Supply Chain – It’s Not Just A Label On A Box

    Typically Clinical Research Organizations (CROs) involvement in the clinical trial process has centered on site management in terms of identifying potential sites and managing patient recruitment. They also offer services related to activities such as protocol development, data management, laboratory services, and toxicology analysis amongst others. Managing clinical supplies has always been seen as a backroom activity, one which sponsors tended to keep a firm hold on, perhaps highlighting their importance to the sponsor in terms of meeting First Patient In (FPI) deadlines.

  10. Managing eCOA Device Allocation And Resupply In Clinical Trials

    Electronic Clinical Outcome Assessment (eCOA) has, in the past decade, become increasingly popular in global clinical trials to the technology’s ability to provide more complete data collection, boost patient compliance and manage patients in real-time.