Case Study 2: Supporting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

Assisting the Sponsor with Database Transfer Solution

Anayansi gamboa - Data Management Support @RAeClinica

 

The Scenario:

The Sponsor required a large safety and data management team to assist with a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety, and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborates with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

RA eClinica is an established consultancy company for all essential aspects of statistics, clinical data management, and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers, and medical devices.

The company is headquartered in Panama City and represents offices with business partners in the United States, India, and the European Union. For a discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

Published by AnayansiVanDerBerg

“I am someone who influences my own development. I look for a company where I have the opportunity to pursue my interests across functions and geographies, and where a job title is not considered the final definition of who I am, but the starting point.”

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