“The only constant in life is change”-Heraclitus. This cannot be truer in today’s context.
In the past two decades, clinical research industry, has gone through a paradigm shift from the use of paper-based systems to web based electronic systems and from traditional 100 percent onsite monitoring to a combination of centralized statistical monitoring and reduced onsite visits.
The changes have been further compounded and accelerated by the COVID-19 Pandemic, wherein onsite visits for monitoring and auditing have become history.
Overnight the industry is faced with the challenge of setting a new normal while keeping the standards and quality intact and ensuring that the rights, safety, and well-being of the trial subjects are protected.
At ADAMAS, we are prepared for this challenge!
Our remote auditing and assessment options with the use of the latest available technology will ensure that you maintain a continuum in meeting your quality obligations. Our remote audits and assessments are carefully designed and customized to ensure that all aspects of processes and data required to protect the rights, safety and well-being of clinical trial subjects are covered by our highly experienced auditors conducting these services.
At ADAMAS we also have an observations database (Insights) which can analyse a sponsor’s risk areas from past studies and can be used to target quality audits on these areas in ongoing or future studies.
In addition, we conduct routine data assessments (RDAs) at a pre-determined frequency to assess the integrity of the data. The objectives of RDAs are to evaluate completeness, quality and timeliness of data reported to the Sponsor. RDAs involve review of datasets against key risk indicators (KRIs) and established quality tolerance limits (QTLs) to identify the data anomalies at subject/site/study levels, data integrity issues (audit trail, data corrections), high-risk areas/sites and systematic study level deviations.
Both the above approaches enable problems to be identified and resolved at an early stage before they become major or critical issues. Any serious issues identified during these assessments would lead to a remote site assessment initially and probably followed up by an on-site audit as permissible. The overall benefit of this approach is that quality can be monitored more frequently and only those sites where serious issues were observed would need to be audited, resulting in a more efficient use of available resources, and faster and more focused quality improvements.
“The problems we have today, cannot be solved by thinking the way we thought when we created them”. – Albert Einstein