The Diligent Qualification Platform, built upon industry standards developed through the Avoca Quality Consortium, accelerates vendor qualification and selection and reduces risk often associated with choosing a clinical service provider.
Regulatory requirements mandate that sponsors “maintain oversight of any trial-related duties and functions carried out on its behalf”. This includes all activities that are outsourced to providers.
Given the changing clinical trial landscape—evolving regulations, increased use of technology for data collection, and more complicated protocols—it can be challenging for sponsors to identify and select qualified providers.
In 2016, The Avoca Group, a life sciences consulting firm with fluency in global regulatory requirements and more than 20 years’ experience in clinical outsourcing, recognized that the process of qualifying providers must facilitate compliance across all outsourcing categories.
Leveraging pre-qualification tools (i.e., standards, RFIs, and scorecards) developed by the Avoca Quality Consortium® and its Member companies, a pilot of the Diligent Qualification Platform was released in 2017. During the pilot, close to 500 RFIs were exchanged between approximately 13 sponsor organizations and 50 clinical service providers. Due to the success of the pilot, in 2018, Diligent was established as a separate entity from The Avoca Group.
The Diligent Qualification Platform offers a range of service levels to meet your specific qualification needs.
Let Diligent help you determine if your provider qualification and oversight processes are ICH E6 (R2) compliant.