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A re-certification of Sponsors product was needed.  To be able to request this, the sponsor needed to collect data retrospectively in several European countries in several investigational sites.

In this specific case study the client is not the Sponsor but an independent Clinical Research Site.  It was at the start of the pandemic in 2020 that this research site experienced issues with available site staff and the fast pace of the data entry. 

Real world evidence data collection of about 200 subjects in 7 European sites.  Data needed to be collected and collected within 5 months of assignment awarded.

Can the SSL support in development of source document worksheets and support in the development of SOPs?