Regulatory requirements mandate that sponsors maintain oversight “of any trial-related duties and functions carried out on its behalf,” including all activities that are outsourced to providers. This can be difficult given the changing clinical trial landscape, including evolving regulations, increased use of technology for data collection, and more complicated protocols.
The Avoca Group recognized that the process of qualifying providers must also evolve to one that facilitates compliance across all outsourcing categories.
The Diligent Qualification Platform was built based on The Avoca Group’s 20 years of experience in clinical outsourcing as well as the company’s fluency in global regulatory requirements.
Diligent serves as a centralized repository of provider-completed RFI questionnaires that are based upon industry standards developed through the Avoca Quality Consortium® and its Member companies.
The Diligent Qualification Platform offers a range of service levels to meet your specific qualification needs.
Diligent reduces your organization’s risk of non-compliance with ICH E6 (R2) by providing a centralized, data-driven, and cost effective cloud-based platform. The Diligent solution allows for accelerated and highly informed decision making in your vendor selection process.
With the Diligent Qualification Platform, you can:
Reduce your ICH E6 (R2) compliance risk
Enable data-driven, higher quality decisions for provider selection
Onboard new providers and capabilities in shorter timeframes
Streamline the data collection process
Access robust tools and business processes
Utilize a more cost, time, and resource efficient model
Reduce your administrative expense
Let Diligent help you determine if your provider qualification and oversight processes are ICH E6 (R2) compliant.