Risk Assessment

Made SimpleTM

About Us

The Beginning

In response to the FDA new guidance in August 2013, “Oversight of Clinical Investigations: A Risk-based Approach to Monitoring,” Melissa Becker, the president and founder of Adaptive Risk Systems™ took a different approach to addressing risk-based monitoring.  Instead of expounding on the current process for assessing investigative site and study risks with the use of data management and statistical programs (that take a higher-level look at study risks mainly through data entry, query metrics and protocol deviation reporting), she decided to assess the current industry study monitor report and the data that it required. This is one of the first points where the issues and root causes for critical investigative site and study issues are identified.  

During her analysis of the industry study monitor report, she noticed several important aspects of the current way investigative site information is captured within the study monitor report:

  • Information captured by the study monitors varied dependent upon: 1) the experience of the study monitor; 2) the disease indication being studied; and 3) the study phase
  • The study monitor was not always certain what information needed to be entered into the study report (either from lack of experience and/or ambiguity of the question)
  • The monitor report did not allow for easy identification, tracking, and management of investigative risks identified, leading to unaddressed and unresolved issues that would continue throughout the life of the study. Thus, these issues would not be addressed until database lock, impacting study budgets and timelines due to the need for additional clean-up of issues that impacted the evaluation of the study product’s safety and efficacy data
  • The analysis revealed a gap in the market place for a comprehensive system that uses the information within the monitor visit report to assess, monitor and manage investigative site and study risks. As a result, IRMA™ (Intelligent Risk Monitoring Assessment) the program was created.

    The Company

    Adaptive Risk Systems™ has recognized the importance and need for quality review of study data, reporting of accurate results and the impact or consequences that result when these are lacking. It is estimated that 72% of clinical trials run behind schedule and an estimated $660,000 to $8 million lost for each day that the clinical trial is delayed 9. Many of these delays caused by the need for additional data clean-up that translates to increases in study monitoring activities. With monitoring activities comprising 25-50% of clinical trial costs 9, the impacts to study timelines and study budgets for the re-monitoring of discrepant data can be exponentially high and unnecessary if identified and addressed by the Clinical Research Associate (CRA) early in the study. In addition, information based on large CRO experience estimates that at least 1/3 of studies end up needing repair or being rescued 7 as evidenced by a proliferation of Contract Research Organizations (CROs) offering services for ‘rescue’ studies 9.   

    Adaptive Risk Systems™ specializes in the development of products that mitigate risks by the use of simple risk-management programs that:

  • Use a proprietary algorithm that provides risk scores
  • Aid in early detection of risks
  • Allow for real-time risk management
  • Perform risk trend analysis
  • Provide mitigation & corrective action plans
  • Adaptive Risk Systems™ risk assessment system provides a means for the industry to monitor investigative site and study risks proactively, with early detection of deficiencies in investigative site and/or CRA performance; identification of potential risks to data integrity; and accurate data output. Early identification of these deficiencies will significantly assist in the reduction of costs associated with ‘rescue work’ and on-site monitoring visits. The ‘Risk Assessment System’, called ‘IRMA’ (Intelligent Risk Monitoring Assessment) is an effective cloud-based program designed with the International Conference on Harmonisation and Good Clinical Practice (ICH/GCP), European and FDA guidance’s in mind.

    Our first product for the clinical trial industry is an intelligent risk monitoring assessment (IRMA™) tool. Created for the Clinical Research Associate (CRA), Study Manager and Sponsor to quickly identify and manage risks at the investigative site and study levels. It is the first tool in the industry that incorporates risk management, risk identification, ICH/GCP and regulatory guidance’s into the monitor visit report, allowing the investigative team to perform their roles effectively and in compliance with regulatory guidance’s.

    Adaptive Risk Systems™ is dedicated to assisting the clinical team in meeting the industry goals for risk-based management and strives to make this new type of monitor visit report and risk-based monitoring system one of the industry standards.

    Company News
  • WRAL writeup CED Life Science presenter profile ARS
  • The Team
    Melissa Becker, President, Co-Founder
  • 15 year’s experience in the field of clinical research with a concentration in study management.
  • 3 years as Nurse Practitioner and 17 years as RN.
  • Has held leadership roles in both CRO and Pharmaceutical companies.
  • Krishna Bhupalam, Vice President of Technology
  • Over 20 years of experience in IT industry working with small, medium and multi-national companies.
  • Extensive experience in domains like Pharmaceutical, Healthcare, Automotive, Government-IT (IRS, DoD, DoT, Census Bureau etc.)
  • Steven Fontana, General Counsel
  • Registered U.S. Patent Attorney for the past 25 years with international IP and transactional experience.
  • 11 years as Corporate Counsel
  • 20 years of technology development experience, bringing products to market
  • Contact Us

    An asterisk (*) indicates a required field.
    Name *
    Email *
    Spam Protection
    Enter this word: