case study


The Situation

RxRS was selected by an international Pharmaceutical Company to staff its regional clinical research trials with contract research workers who had scientific expertise, medical backgrounds and regulatory compliance training.

Field Based Regional Work – 24 States:

  • Workers were needed to perform on‐site data monitoring, document validation and verification, source data analysis and verification at over 750 hospitals located in 24 states.
  • Workers needed to be able to travel and be willing to commit to a 1 year time period.

High Document Volume:

  • The combined scope of the project involved more than 1,500 patients.
  • Each patient had a lengthy medical history, and involved over 100 pages of source treatment documentation.

Extensive Data Monitoring Expertise Required:

  • The Pharmaceutical Company required contract workers to visit each hospital and clinic to verify operational compliance with the technical treatment protocol, perform source documentation review, collect data from original records, validate data criteria, assess protocol compliance, review product inventories, perform data validation and data analysis, prepare medical reports with accuracy and expertise so as to comply with a federal government regulatory reporting requirements.
  • Each worker had to be detail oriented, observant and adherent to quality control and regulatory processes.
  • As the Pharmaceutical Company faced a time critical and business sensitive deadline, the
    Pharmaceutical Company turned to RxRS to recruit and manage these essential workers during this critical time of need.

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