Emerging Pharma Empowered By Technology and Services

posted on February 1st 2015 in Case Studies with 0 Comments /

An emerging pharmaceutical company in the Southern California / San Diego area is developing unique oncology therapies, and in support are conducting and planning for a number of Phase I and II clinical studies to support their development goals. Although having a limited number of personnel and staff, the organization had a defined vision of how they wanted to collect, manage, and utilize their clinical data. Their objectives included:

  • Implement and leverage an industry-leading data acquisition platform that would provide needed functionality and support their trial work from Phase 1 and beyond.
  • Develop a data standardization and analytics strategy, allowing efficient utilization of data being collected.
  • Partner with experienced data management professionals that would act as complete extension of clinical team, remaining consistent through their development program and pro-actively identify program level efficiencies to save time and money.
  • Establish a methodology to access their clinical data, at any time on demand, for visualization and reporting without the need of complex programming

Our Solution
eClinical Solutions outlined a comprehensive plan that addressed both their short term and long term objectives, offering standardization in three key areas: technology, process, and data standards.

  • eClinical Solutions first set out configuring their initial clinical study utilizing the Medidata Rave® platform. eClinical has dedicated their expertise and personnel to leveraging this industry leading EDC platform based on superior functionality, support, and ease of use from the clinical site perspective.
  • eClinical implemented what became the foundational cornerstone of the organization’s clinical development program, the elluminate® platform for data aggregation, standardization, and analytics. This industry changing technology would enable the Sponsor to aggregate all their clinical data, standardized in SDTM format, and access it on demand through integrated Business Intelligence.
  • eClinical Solutions planned and resourced data management activities on a program level to identify potential efficiencies.

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