Transforming Trials
The traditional clinical development model needs to change.
Improving Pharma R&D Efficiency
The cost pressures on drug development are driving the search for savings. Download our in-depth white paper based on an industry survey of pharma executives.
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands.
These include managing product pipelines targeting smaller and more heterogeneous indications, meeting rising standards of evidence from payers that are moving towards value-based reimbursement models, and addressing the patient’s rising role in care decisions.
Our industry must adopt an entirely new framework for development infrastructure and processes. Focus must go beyond cost containment alone, and instead unlock value through fundamental reforms that allow sponsors to move more treatments to market faster.
Increasing complexity and declining ROI in Drug Development
Find out more about how other organisations such as TEVA and UCB Biosciences are managing the evolving challengest of drug development and the unique insights of an eminenet Doctor who has unique insights because of his varying rolese in the industry.
Topics covered in the report:
- Is increasing complexity, reality or myth?
- Complexity: a necessary evil or is there a better way?
- Drug development with fresh eyes and new perspectives
- Patient power and dynamics
- Engaging the investigator for better outcomes
- Virtual trials – extending the reach of clinical trials Areas of focus to decrease the cost of R&D
Utilising Emerging Technologies
Chen Admati (Intel) and Marie McCarthy (ICON) talk about utilising emerging technologies to improve the efficiency of research and development in the pharmaceutical industry in this PharmaVOICE podcast. Listen now.
ICON’s Transforming Trials initiative is a continuous quality improvement process that
- Confronts fundamental risks that cause high failure rates
- Disrupts inefficient processes with EHR-driven analytics
- Integrates payer, provider, and patient priorities at early decision-points
- Accelerates precision medicine and development for rare and orphan indications
- Leverages mobile technologies both to enhance trials and support a product ecosystem
- Facilitates a continuously learning clinical ecosystem
Much of the foundational innovation needed to transform clinical development enterprise exists today, and enjoys explicit regulatory support.
Improving Pharma R&D Efficiency
The cost pressures on drug development are driving the search for savings. Whilst large-scale operational efficiencies are being instituted in many pharmaceutical organisations, efforts need to be integrated if they are to be effective.
Real World Intelligence™
Based on deep insights into emerging evidence needs, ICON experts design real-world data collection strategies that build a compelling clinical and economic case as trials progress rather than after regulatory approval – often saving millions in post-market study costs and payer authorisation delays.
- ICON Real World Data (RWD) Insights
- White Paper: Harnessing Technology to Maximise RWE Value
- ICON and ICHOM unveil the world’s first global patient outcomes benchmarking platform
- White Paper: Meeting Evidentiary Needs with EHRs
- On Formulary Fast: Accelerating the Access and Reimbursement Process
- Reduce the Cost of Post-Market Surveillance with Real-World Data
Adaptive Design
Adaptive designs remove unnecessary risk from trials, both for patients and sponsors. ICON combines powerful statistical methodologies with novel technology suites such as ADDPLAN and FLEXADVANTAGE to design and execute efficient studies that mitigate problems that too often undermine good products.
Design for the Patient Experience
ICON is empowering patients, encouraging compliance, and easing the burden of participating in trials through its FIRECREST digital platform, backed by extensive research on behavioural decision-making and information technology.
- ICON Reveals Voice-Assistant Applications for Clinical Trials
- Leveraging Voice-Assistant Technology in Clinical Trials
- How Patients and Developers Benefit in a Digital Health Ecosystem
- Multimedia Approach to eConsent Instils Patient Trust in Clinical Trials
- ICON and Carnegie Mellon University Collaborate to Evaluate Patient-centric Informed Consent Processes
Transforming Trials Email Updates
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Receive Transforming Trials Email UpdatesEMR-Driven Innovation
Vast amounts of data from electronic medical records (EMRs), combined with novel analytics technologies, have the potential to revolutionise clinical trial recruitment and feasibility.
Elevate Site Centricity
ICON is transforming the daily experiences of site staff through novel technologies that reduce the burden of participation and a novel centralised site management model, delivered through regional hubs fluent in local languages and customs, that provides a single point of contact from start to finish.
Leverage Mobile Technology
ICON is investing heavily in security and data validation standards for wearable devices and mobile applications, so that sponsors can take advantage of opportunities to augment clinical and economic outcomes measures, and make studies more convenient and accessible for patients around the world.
- White Paper: Transforming medical device development with mHealth
- Remote monitoring, wearables and sensors in clinical trials
- BYOD in clinical trials
- Measuring Free-Living Activity in Clinical Trials
- Bring Your Own Device (BYOD) eCOA – Instrument Validation Methodology
- ICON Pilots New App for Aging Research in Connected Health Study