INSIGHTS ON CLINICAL TRIAL DESIGN

  • COVID-19: Trials, Designs And Tools For Promising Results

    How can we harness the power of data science and trial design to achieve expedited clinical development for a new coronavirus vaccine? Experts from around the world weigh in on this panel.

  • A New Era In Dermatology: Study Design, Regulatory Strategies, And Patient Participation

    This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical elements when devising effective recruitment and retention strategies.

  • Will New Technologies Accelerate Approval Of New Therapies?

    Can new technologies such as artificial intelligence (AI), machine learning (ML), “bots,” and other digital tools, help accelerate the pace of development and approval of new therapies? This overview from a panel at DIA Europe 2019 looks at the potential impact of new technologies and necessary steps to leverage them.

  • Strategies To Avoid Enrollment Delays

    It is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.

  • Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies

    The evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy. Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials.

  • Best Practices In Site Feasibility Studies Can Set the Stage For A Healthy Trial

    Well-performed site feasibility can become the single most important factor in reducing costs and time spent in a clinical trial. With adoption of benchmarking and clinical trial tools, sponsors are able to know exactly how many sites they need in their trial, which makes site pre-identification essential for efficient study start-up.

  • Patient Engagement And The IRB

    Recent years have seen increased efforts to engage with patient and participant communities and include them more closely in research. Find out how IRBs and other stakeholders can assess potential issues and encourage patient involvement.

  • Putting Patient-Centered Principles Into Practice

    This webinar will explore the rationale for implementing patient-centered practices and offer guidance for initiating patient-centered approaches to research. Review practical strategies for engaging patients in the clinical trial process without sacrificing research quality or adding untenable costs to your trials and understand which factors matter to patients and how to design trials that honor their needs and desires.

  • Supply Chain Models For Global Trials: Singapore As The APAC Gateway To The World

    With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies and clinical supply support. Multiple factors, including positive changes in clinical research regulations, reduced costs to run trials, and large urban-centered populations are attracting sponsors to the region. Watch this webinar to get expert insight on using Singapore as a clinical supply hub.

CLINICAL TRIAL DESIGN SOLUTIONS

  • End-To-End Oncology Development

    Pioneers developing the latest targeted therapies turn here for innovation and expertise. We’ve conducted over 155 trials across numerous indications in the past five years.

  • From Trial Design To CDISC Submission

    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.

  • Speed to Study™ Services

    Pharmaceutical companies need to streamline early phase development to establish proof of concept, efficacy, and stability of their drug candidates quickly and efficiently. Speed to Study™ Services are designed to help companies maneuver complex trial designs with maximized flexibility and speed.

  • Uncover The Evidence You Need To Design Better Trials

    Generate evidence and identify relevant data points from historical clinical trials that can serve as “ground truth” for regulatory submissions or for designing your clinical development programs.

  • EnvisiX Smarter Clinical Trial Budgeting

    Introducing EnvisiX powered by Greenphire; smarter clinical trial budgeting from day one. EnvisiX is an intuitive, data-informed investigator grants creation and negotiation to payment solution that streamlines study start up.