Industry Insights

  1. Proactive Planning Is Key To Process And Quality Improvements In Clinical Trials

    How to employ processes that take an upfront approach to preventing or mitigating problems associated with document completion.

  2. Mobile eTMF: The Pain Of Yesterday.The Relief Of Today.

    Since the launch of myTI—TransPerfect’s mobile experience for the Trial Interactive eTMF—I have heard rave reviews from clinical operations leaders and CRAs. The advantages of mobile technology for clinical operations are generating a lot of excitement, and rightfully so. In my collaboration with study teams during the development, release, and ongoing evolution of myTI, we encountered many thematic pain points that were ripe for a mobile solution.

  3. Pediatric Clinical Trials: The Need for Regulation

    An overview of the progress that has been made in pediatric drug development.

  4. Orphan Indications and Clinical Trials - Recruiting

    Look at ways to proactively recruit so as to overcome challenges.

  5. Orphan Indications and Clinical Trials - Why Rare Diseases Warrant Special Treatment

    Unique characteristics of clinical trials for chronic, rare diseases.

  6. Five Key Considerations For Writing First-In-Human Protocols Under EMA Guidelines

    As pharmaceuticals move from animal to first-in-human (FIH) clinical trials, establishing appropriate strategies to minimise risk in early phase clinical trials is necessary and should be a priority for the safety and wellness of clinical trial participants, whether patients or healthy volunteers. The goal of FIH clinical trials is to study the human pharmacology, tolerability and safety of pharmaceuticals to compare how effects seen in non-clinical studies translate into humans.

  7. Rein In The High Cost Of Cardiovascular Outcome Trials

    Three success factors for leaner operations.

  8. Maximizing Efficiencies In Site Enrollment

    Pharma companies and CROs are recognizing the need for focused electronic feasibility solutions to resolve challenges with processes managed in Excel trackers.

  9. Which Door To RBM Adoption?

    Overcoming the many known barriers to adopting and implementing an RBM program.

  10. Companion Diagnostic Development: Current Trends And Recommendations

    Learn six strategies for success when developing your companion diagnostic.