Transforming Trials

The necessity of appropriately training raters for reducing variability in measurements, rater interpretation, and bias and scale administration errors in COA implementation are outlined in this whitepaper.

In this whitepaper, we explore how these valuable tools, including software, templates and collaborative work processes, can provide practical solutions to common challenges medical writers face.

In this whitepaper we describe the rigorous, iterative linguistic validation process for COAs that ensures conceptual equivalency and cultural relevance for each required translation. 

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.

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.

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:

• 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

• 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.

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.

• ICON guide to adaptive trials
• Adaptive design: The faster path to market for medical devices

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

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.

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?

White paper: Transforming medical device development: achieving challenging mandates for cost savings and pipeline productivity