Patient Data Delivery to Investigator sites | End of study CRF transfer service | CD/DVD despatch | Secure Cloud delivery | Customised solutions by A&O

End of study data deployment - Service plans from A&O

Independent distribution of patient CRF data to sites

Apples & Oranges Data Solutions offers an independent service between the sponsor and study sites with effective delivery solutions for patient data. As A&O is not an EDC provider to sponsors, there are no conflicts of interest that regulatory authorities may have concerns with. A&O does not conduct any clinical trials and is therefore completely independent with post-study closure activities including the delivery of data to investigator. This is different to those EDC vendors who also provide long-term hosting of patient data.

It is essential that sponsors retain a focus with end-of-study patient data distribution requirements and that any solutions comply with all applicable regulatory and national requirements. The main emphasis from a sponsor perspective is always on the initial collection, review and cleaning of data obtained from sites with post study closure activities such as patient data transfer to sites often coming as an afterthought (with cost implications for sites that could have been closed already). In many cases where studies have been outsourced, the task of end of study patient data transfer to sites may not have been included with either the EDC vendor or data management vendor. Costs for this out of contract task can typically exceed $100,000 dependent on study size and other considerations (e.g. number of sites and patients, physical locations of sites, required documentation for sponsor, regulatory authorities etc). A sponsor may be in a better position to invite an external vendor such as Apples and Oranges Data Solutions to fulfill the task of end of study patient data transfer.