INSIGHTS ON CLINICAL TRIAL DESIGN

  • Design Your Trial For Success: Involve Patient Advocates Early

    Trial drop-out rates continue to increase and some clinical trials grind to a halt due to low recruitment and retention rates. Could both be avoided by engaging a patient advocate early on to set patient expectations and allow sponsors to see the trial from a new perspective?

  • Stop Patient Drop Out, Before It Starts

    Patients participating in clinical trials receive benefits in addition to potentially receiving breakthrough drugs and devices. Trial enrollees also receive state of the art care and additional monitoring. However, extra monitoring does not come without additional burdens.

  • Selecting Your Next Clinical Trial Design Using Quantitative Decision Methods

    C-Suite and R&D decision-makers are always striving to make evidence-driven decisions. Yet the rules by which evidence is evaluated can bias these decisions, even when the method of decision-making seems objective. Our Chief Scientific Officer, Dr. Yannis Jemiai, has worked extensively on how to operationalize decision theoretic tools for clinical development decision-making. Here he introduces three quantitative frameworks that life-sciences decision-makers can quickly incorporate into their selection process when selecting an optimal design for their next clinical trial.

  • Meeting Multiple Challenges For A Uniquely Challenging Trial

    A top-20 pharmaceutical company was conducting a Phase III breast cancer study in 16 countries across North America, Europe, and Asia. The sponsor’s CRO leveraged an online site portal designed to facilitate optimal execution of this complex study, and to provide information and support tools to sites in order to increase engagement.

CLINICAL TRIAL DESIGN SOLUTIONS

  • Flexible consent technology improves participant comprehension and process oversight. Medrio’s Consent solution empowers organizations to accelerate all aspects of the consent process, from setting up and modifying forms to ensuring patient comprehension, while remaining in full regulatory compliance.

  • As a key element of study startup, IRB review can have a substantial impact on meeting critical study milestones. Advarra provides flexible solutions to help accelerate the initial IRB review process and make it more efficient.

  • Cytel is committed to improving the quality, analysis and interpretation of data for clinical development. Founded by world-renowned biostatisticians and Fellows of the American Statistical Association, Cytel maintains a tradition of leadership in statistical innovation. Our team is dedicated to improving the probability of clinical trial success and helping to deliver new medicines to the patients who need them.

  • Oracle Health Sciences ClearTrial Plan and Source Cloud Service helps you plan, forecast, and outsource clinical projects quickly and accurately—saving you time and money.

  • Make your clinical trial operations more competitive and your study activation process more efficient with a comprehensive assessment, best practices guidance, and implementation support from Advarra.