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.

Read more about End of study data requirements, regulations and expectations

 
Why consider Apples & Oranges Data Solutions?   
                                             
  • Over 20 years industry experience in both pharmaceutical and CRO capacities

  • Creation of patient PDFs for both small or large studies

  • Inclusion of comprehensible audit trail

  • 100% QC of patient data (Storage data vs EDC data files)

  • Dispatch and receipt acknowledgement service

  • Numerous EDC platforms supported

End of study data transfer Service Plans

Fully customisable service plans:

Service Plan 1: Sponsor media delivery

  1. Data compiled into a data packet per site (as per work order)

  2. Metadata created and streamed to data packet

  3. Packet QC process

  4. Data packet transferred to media and secured

  5. Media QC

  6. Media transferred to sponsor for shipment to sites

  7. Sponsor manages site acknowledgements

Service Plan 2: Site media delivery

  1. Data compiled into a data packet per site (as per work order)

  2. Metadata created and streamed to data packet

  3. Packet QC process

  4. Data packet transferred to media and secured

  5. Media QC

  6. Media distributed direct to sites

  7. A&O manages site acknowledgements

  8. Final site acknowledgements sent to sponsor

Service Plan 3: Site delivery via A&O's cloud  solution - SDDS

 
 
 
 
 
 

  1. Data compiled into a data packet per site (as per work order)

  2. Metadata created and streamed to data packet

  3. Packet QC process

  4. Data packet transferred to Secure Data Distribution Service (SDDS)

  5. Site download patient data to local location

  6. Site acknowledges data receipt via SDDS

  7. A&O management of data receipt

  8. Sponsor receives site acknowledgements from SDDS

Typical SDDS workflow

 
Secure Data Delivery Service site delivery of patient data.png
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