INSIGHTS ON CLINICAL TRIAL DESIGN

  • Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research

    Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

  • Allergan: Key Considerations When Evaluating A Study Start-Up Application

    Allergan shares actionable tips for evaluating a study start-up application and best practices for change management and training.

  • Direct-To-Patient Model Keeps Research Moving And Patients Safe

    In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive treatment.

  • Identifying Choice Trial Designs Using Pareto

    Economists have long used the concept of ‘Pareto Efficiency’ to refer to the optimal allocation of resources with respect to a set of preference criteria. This position paper reviews how the idea of Pareto Efficiency, also called Pareto Optimality, can be used for the strategic selection of a clinical trial design, rapidly identifying which designs are most aligned with an organization’s business goals like speed-to-market, savings in development costs and likelihood of success.

  • Advancing Decentralized Clinical Trials Through A Unified Approach To eCOA And Digital Health Technologies
    7/6/2021

    Digital Health Technologies (DHTs) combined with assessments of patient-reported outcomes (PROs) are on the rise. Read how uniting these two complementary mechanisms better informs how patients experience their disease and respond to treatment.

  • Alnylam Puts Sites And Patients First With IQVIA Technologies Investigator Site Portal
    3/19/2021

    When Alnylam Pharmaceuticals began development of medicines for rare diseases with few or no treatment options, the company’s leaders knew they needed to design clinical trials that kept patient well-being and disease burden at the forefront. As Alnylam’s first clinical program began in 2014, the study team saw emerging site-facing technologies as a foundation for those trusted relationships, starting with a purpose-built communication channel and easy-to-use study conduct tools to support a complex protocol.

  • Blood Disorder Clinical Trials – Adapting To COVID-19 Challenges
    7/2/2021

    The spread of COVID-19 has heightened the potential risk of infection for patients suffering from blood disorders. Hematologist Dr. Robert S. Negrin, a new member of Biorasi’s growing Scientific Advisory Board, weighs in on understanding and adapting to changes to blood disorder trials and treatment during the pandemic.

  • Increasing Patient Engagement With The Clinical Research As A Care Option Model
    6/30/2021

    It is estimated that as little as 3% of adults with cancer participate in clinical trials. At the same time, recent surveys have shown that up to 75% of patients say they are willing to participate in a clinical research study, indicating that many more people would take part in studies if given the opportunity. Clinical research as a care option, also known to the clinical trial industry as the CRAACO concept, offers a solution to the participation and awareness gap. This article explores the benefits of CRAACO for all stakeholders in healthcare, and outlines some of the steps necessary to turn this option into reality.

  • Applying Virtual Approaches To Dermatology Trials
    3/4/2021

    Dermatology patients are eager to participate in trials from their homes during the COVID-19 pandemic. Sponsors and investigators managing dermatology clinical trials have quickly embraced remote and virtual tools to keep patients safe and keep trials moving forward. Join our webinar and learn how to incorporate virtual approaches into the design and delivery of dermatology trials – to lower overall study risks and increase patient engagement.

CLINICAL TRIAL DESIGN SOLUTIONS

  • IQVIA Decentralized Trials deliver purpose-built clinical and technology solutions that engage the right patients wherever they are. Our hybrid and fully virtual models have been fine-tuned through more than 70 decentralized clinical trials (DCTs) across more than 10 therapy areas and 40 countries. Together with our partners, IQVIA speeds study startup and recruitment, strengthens retention and improves data quality by leveraging IQVIA’s transformative technology, unparalled data and therapeutic expertise.

  • When time-reduction, cost-savings, quality and reliability matter, ropack pharma solutions is the distribution partner positioned to deliver.

  • Cytel’s dedicated team of professionals is here to help you address an array of challenges when conducting drug development. Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial implementation, Cytel has skilled professionals available when you need them.

  • Why Move to a Decentralized Model? The benefits to your patients and your team are plentiful. Removing the patient burden of always coming into the clinic increases recruitment, compliance, and patient engagement. Plus, the ability to stay in close contact with patients regardless of location diversifies participant populations and allows very ill patients to participate.

  • CRO manages multiple, complex statistical analysis deliverables for a program of studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.