While the globalisation of the clinical trial sector and increased use of multi-center studies has improved access to diverse populations and opened up emerging markets, it has made all aspects of management more complicated and time consuming.
One of the most critical of these areas to be affected, from both a patient safety and regulatory perspective, has been the collation and reporting of serious adverse events (SAEs), at least, it has according to Medidata.
The firm suggested that: “Today's process of collecting complete and accurate SAE information relies heavily on multiple exchanges including phone conversations, paper forms and faxes between sites and sponsors.
“In addition, sites must bear the burden of communicating this information to sponsors via a separate paper process. These laborious and redundant manual efforts are further compounded by the need to reconcile clinical and safety data at the end of a trial.”
Medidata’s solution to these challenges is the Rave Safety Gateway, which is designed to automatically transmitting safety data from trial sites to sponsors' in the International Conference on Harmonization (ICH) industry standard E2B file format.
This approach, the firm believes, allows streamline reporting efforts in a manner that complies with global regulatory requirement and significantly reduces the burden of collecting and reconciling safety data.
Medidata president Glen de Vries “Rave Safety Gateway enables our customers to build a fully electronic, standards-based process to submit all SAE-related data captured in EDC to the safety system of their choice with minimal effort.”