Help us collect Real-World Evidence to Evaluate Treatments for COVID-19

This initiative is in response to the FDA guidance “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” that was published on March 20, 2020. The purpose of this exercise is to simplify and facilitate the collection of data on treatment outcomes and adverse drug events for approved drugs and biologics and investigational products that are used to treat COVID-19.

Clinical Research Meets the Future

ACRES systems solutions address the complexity of the research enterprise and its problems including economics, patient accessibility, globalization, regulatory burdens and ethical issues.  ACRES is:

• Providing a platform to connect stakeholders and bridge silos
• Developing uniform standards, policies, and processes
• Leveraging interoperable, integrated information technologies
• Establishing a global framework to enhance quality and safety
• Empowering patients as partners

How ACRES Stakeholders are Fixing Clinical Research

ACRES provides leadership and an “engine” for initiatives necessary to build and implement:

• A network of accredited, high-performing, sustainable research sites
• A shared, open-access, integrated information technology platform
• An expanded cadre of well-trained clinical research professionals
• Effective safety, risk management and quality improvement processes
• More effective regulatory systems, ethics committees and recruitment

Building a Global System for Clinical Research

ACRES global system and ongoing feedback mechanisms overcomes challenges in medicines development.  This systems approach:

• Drives and rewards standardization, permitting regulatory innovation
• Improves performance across the enterprise
• Creates incentives to achieve excellence and reward professionalism
• Aligns ethics with good business and scientific practices
• Increases transparency and security to improve public trust
• Provides a universal open-systems infrastructure for clinical research

Transformation Through Systems Thinking

ACRES collaboration is overcoming today's challenges in clinical research.  Its objectives include:

• Reducing the 30% waste in this $70 billion annual enterprise
• Shortening the 10-15 years needed to bring a new drug to market
• Reducing the $2.6 billion price tag for developing a new medicine
• Transforming the 70% of sites that currently conduct only one trial
• Building public confidence in the medicines development industry