Late-Phase Trial Strategy & Technology

edc1Clinical trial leaders are facing a new paradigm in the industry: rather than taking a strategy vs technology approach, leaders are now adopting a strategy and technology approach in order to incorporate customized technology into their clinical trial strategy. This is in particularly true for late-phase studies which has become extremely relevant in the drug development process. Pharma companies are focusing on managing the full product life cycle rather than just gaining market approval. Arithmos discusses technology strategies for late phase studies.

Identifying the Need:

Late phase studies are identified by rigid protocols and a shift from a small number of selected patients to a large number of normal patients. Most Life Sciences Commercial Off-the-Shelf (COTS) applications provide standard and common functionalities at comparable costs. Many COTS EDC systems address most requirements, but customization is often needed. Custom software can be developed to fit company’s business processes and operational needs starting with an established and tested software basic version.

COTS can have drawbacks such as too many or not enough functionalities, high licensing  and helpdesk costs and low usability. Meanwhile, custom software applications can incur high development costs, bugs, high training and helpdesk costs, limited reuse of software code and the inability to use manuals and documentation for other projects.

Identifying the Solution:

Customizable Life Science Applications are a middle ground between COTS and Custom Software. Benefits include:

  • Paying for the functionalities needed and not paying for those not applicable to your study
  • Ability to reuse the application with slight modifications
  • Reuse of documentation
  • Training effort kept to a minimum due to high usability
  • Sponsor and site personnel use the same application for different projects

Example of Customizable Software Solution in Use

Arithmos developed a baseline EDC software based on requirements written by investigators. The basic functionalities such as data entry, source data verification, discrepancy management, eCRF approval have been implemented. Other features include study design and build, smart logical security and documentation and reporting sections. From this baseline, Arithmos has created 5 customized versions of the software for 5 different sponsors. In this particular case, the creation of a model application was to be cloned and customized according to customer requirements. A customized version can then be used for more than one study, and study setup and logical security can be easily managed. Documentation can be centrally managed on a study/user level, and reports can be customized study by study.

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Arithmos has developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data for late phase studies. The system can be aligned and customized to client requirements and is ideal for studies which require a reliable, but cost-effective solution. Classic EDC features include: electronic data collection, easy study database build, integration with ePRO, audit trail, query management, and SAE management. To learn more about this software join the LinkedIn System User Group or visit Arithmos at an ePharma Day event this fall for a full explanation of the case study.

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