The Challenge
Following the December 17, 2014, FDA binding guidance that all pharma studies starting after December 17, 2016, must conform to a set of FDA-sponsored standards, formats and technologies, pharmaceutical companies found themselves in need of a tool or process for ensuring the standards were being met and followed. One major pharmaceutical company had already put a tool in place in an effort to follow the CDISC standards, but they required assistance in fully implementing the tool. Although the tool they had installed was a good starting point, it had not yet been completely tested or qualified, so it was unclear whether the tool would work as intended – leaving open the possibility that drugs that passed through the system would be rejected by the FDA for not meeting the required standards.
The Solution
CMK Select supported the pharmaceutical company’s clinical and statistical business teams in identifying the gaps in the existing tool and processes, in terms of its capabilities and what the FDA binding guidance required. CMK helped the company implement three key components to ensure accuracy and consistency in meeting the new standards: a metadata repository for the storage and maintenance of clinical data standards; a Pinnacle 21 Enterprise software to support compliance validation checks and standards; and a change-request and workflow system to support standards governance. CMK also helped to develop and re-engineer the operational processes to support the standards implementation.
Results
With the updated tools and processes in place, the company is able to ensure that all studies meet the CDISC standards prior to submission, minimizing the possibility for rejection and the subsequent need for correction and resubmission. By guaranteeing conformity from the start, the company is able to avoid any delays in launch that would ultimately lead to major losses of time and revenue.
CMK SELECT 