The traditional clinical development model needs to change.
With the rising cost and time to bring new drugs to market, the demand for decentralised and hybrid trials has steadily risen.
Insights on customised FSP models, transformational roadmaps and operational execution to enable the most flexible and efficient operating models for Sponsors.
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.
In this whitepaper we describe the rigorous, iterative linguistic validation process for COAs that ensures conceptual equivalency and cultural relevance for each required translation.Read the whitepaper
The prerequisites for controlled use of Clinical Outcome Assessments (COAs) and suggestions for streamlining the licensing process, which can be complex and typically involves multiple parties, are detailed in this whitepaper from Mapi Research Trust.
Read the whitepaper
In this whitepaper we describe what is involved in adopting an eCOA solution and share a recommended approach to planning and implementing eCOA that will eliminate surprises and mitigate the risks of delaying the study start up.Read the whitepaper
Scientific posters are in need of a design overhaul. Poster sessions are a valuable opportunity to communicate research with a large audience. However, traditional posters rely on an information-dense design and often fail to make a lasting impression.Read the whitepaper
Our risk based, patient focused methodology for the design and execution of an adaptive monitoring strategy already has a quality management system, risk management system and innovative proprietary technology to support implementation of new ICH GCP guidelines.Read the whitepaper
Find out how ICON helped a client that was looking to deploy a more effective clinical trial technology platform that would meet its needs across a wide portfolio of studies.Read the case study
Our whitepaper examines how agile clinical monitoring provides the flexibility to keep your trials on track.
Find out more about how other organisations such as TEVA and UCB Biosciences are managing the evolving challenges of drug development and read the insights of an eminent doctor who has a unique perspective due to his varying roles in the industry.
Topics covered in the report:
ICON's Dr. Greg Licholai, Chief Medical & Innovation Officer took part in a panel discussion: Dynamic clinical trial models at the 2022 Financial Times US Pharma and Biotech Summit. The panel discussion covered a wide range of topics including how the COVID-19 pandemic accelerated innovation in clinical trials, especially in terms of how to connect with patients and investigators.
The challenges of the pandemic have pushed CROs and sponsors to embrace new ways of conducting clinical trials that offer significant advantages going forward. At the 2021 Financial Times US Pharma and Biotech Summit, ICON CEO Dr. Steve Cutler discussed these developments in a post-pandemic clinical trials landscape and recent developments in the CRO market.
Watch ICON’s CIO, Tom O’Leary in conversation with Hannah Kuchler, US Pharma and Biotech Correspondent discuss digital disruption in pharma and the need to transform clinical trials. Recorded late November 2019 at the Financial Times Global Pharmaceutical and Biotechnology conference in London.
Much of the foundational innovation needed to transform clinical development enterprise exists today, and enjoys explicit regulatory support.
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.
Adaptive designs remove unnecessary risk from trials, both for patients and sponsors. ICON combines powerful statistical methodologies with novel technology suites such as FLEXADVANTAGE to design and execute efficient studies that mitigate problems that too often undermine good products.
The International Council for Harmonisation (ICH) guideline E9 Statistical Principles for Clinical Trials was issued in 1998 and in November 2019 an addendum to ICH E9 (R1) was issued relating to estimands and sensitivity analyses. This Whitepaper outlines the basics of estimands, and discusses their proposed deployment for improving the quality of clinical research.Read the whitepaper
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 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.
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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.
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.
To sustain rapid revenue growth, medical device manufacturers are increasingly turning to significant corporate cost saving programmes, often requiring across-the-board cuts between 15 and 30%.
Companies are under enormous pressure to introduce products to market faster while also meeting the escalating demands of regulators and payors for post-market research, requiring investment in infrastructure and expertise to maximise reimbursement and keep products on the market.
How can manufacturers effectively reconcile these seemingly contradictory challenges?