Life Sciences

Migrating Legacy Clinical Data From CRO To Sponsor

clinical-data-migration-cro-sponsor

 

Sponsors are known to work with multiple contract research organizations (CROs). And, depending on the agreement in place with each CRO, data can be captured in either the sponsor’s systems (CDMS and/or EDC) or the CRO’s.

If the data is stored in CRO databases, there may come a time when it needs to be migrated to the sponsor’s systems. One example is when a sponsor is interested in doing cross-study statistical analyses that include legacy studies. 

The complexity of such a data migration ultimately depends on the file format(s) involved, such as Word, PDF, Text, SAS listings, scans of SAS listings, and Excel listings. It is also affected by the amount of data being transferred, the assumptions being made about the data, and the conversions that need to be performed on the data. Each file format can require a unique migration process, so it is important that the process be documented in detail.

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Below are some high-level examples of the process it takes to migrate data into an Oracle Clinical database from the file formats mentioned above.

Word (or Word converted to PDF) Listings

  1. Build study in Oracle Clinical
  2. Convert listing to TXT
  3. Parse TXT document into Excel
  4. Parse to batch data load (BDL) format
  5. Load into Oracle Clinical
  6. Quality Control

Text Listings

  1. Build study in Oracle Clinical
  2. Split listing into one document per page
  3. Parse listing into Excel
  4. Parse to BDL format
  5. Load into Oracle Clinical
  6. Quality Control

SAS Listings

  1. Build study in Oracle Clinical
  2. Convert listing to Excel
  3. Parse to BDL format
  4. Load into Oracle Clinical
  5. Quality Control

Excel Listings

  1. Build study in Oracle Clinical
  2. Parse listing to BDL format
  3. Load into Oracle Clinical
  4. Quality Control

Scans of SAS Listings

  1. Build study in Oracle Clinical
  2. Perform 1st and 2nd pass data entry on the listings
  3. Quality Control

If your organization has an upcoming data migration project, we’d love to talk with you. And, don’t forget to register for our upcoming webinar How to Make Wise Post-Production Changes to Oracle Clinical Remote Data Capture Studies.

 

About the Author

Tammy Dutkin is a seasoned professional with more than 20 years of experience in clinical research and data management. As director of clinical data management and EDC in Perficient's dedicated life sciences practice, she is responsible for the overall development and management of the department's clients and projects. Her core competencies include operational excellence, training, process and technology development/implementation, and quality management. Prior to joining Perficient via the acquisition of BioPharm Systems, Tammy was the senior vice president of operations at DSP Clinical Research and the vice president at Advanced Clinical.

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