Streamlining Research Study Process for Contract Research Organization

Case Study: Custom Dosing Application

Challenge:

An innovative contract research organization (CRO) that conducts bioanalytical and pharmaceutical testing services for the biotech and pharmaceutical industries was having issues managing their high volume of complex, multi-day studies. The organization had been following an ad hoc process to manage the numerous activities that were performed while conducting studies, using spreadsheets to record and collect the data for Pharmacology and In Vivo studies. Because of the different needs of the In Vivo and Pharmacology groups, the organization contacted Aciron to develop a comprehensive study management system that would allow users to manage their studies and operations digitally.

Approach:

To begin the project, Aciron worked with the organizations’ key stakeholders to perform rigorous hands-on requirements gathering activities in order to better understand the needs of the client. We then defined and documented the client’s multi-faceted study management process and developed a roadmap for the application so that it would work for all study types. After a current state assessment and requirements gathering interviews, it was decided that a phased approach to the development of the custom dosing data collection application would enable the client to use the system for its most critical needs quickly, as well as to ensure user adoption and engagement and to minimize disruption to end users.

Given the organizations’ studies’ complex nature, the Aciron team developed storyboards with interactions to visually articulate the various scenarios that the study coordinators and scientists would encounter while executing a study. The clickable prototype allowed Aciron to walk the study team through an entire study lifecycle in the system and enabled the client to provide feedback before any code was actually written. Aciron regularly reviewed the storyboards and process flow diagrams with the client to demonstrate how the system would be developed, brainstorm modifications, and allowed the client to provide feedback and input through the design and development process. Using the established strategy and design and our understanding of requirements for the system update, Aciron developed the system tailored to the client’s specific needs.

Solution:

Aciron developed a custom study management system featuring a dosing and collection schedule feeder that automatically calculates all upcoming doses and collections based on criteria that users enter when creating a study. The system allows study and project managers to have the entire study protocol and current status at their fingertips and to generate mid-point and end-of-study reports with the click of a button. Other features of the application include:

Additional features of the application include:

  • Study Observation Form, which allows users to record their observations digitally and aggregate these records into one location as the study progresses
  • Printable study documents, which can be added to testing equipment to help users better track every aspect of the study
  • Robust Security Infrastructure, including Active Directory integration & role-based permissions for enhanced security
  • Timepoint Ticker, featuring daily and hourly study timepoints that appear on the system interface like a scrolling ticker

Utilizing a flexible, agile methodology Aciron designed the system to allow for updates and enhancements to be made over time. The custom dosing data collection application standardized the client’s study creation process, automated the dosing and collections process, reduced the amount of time that researchers spent creating study documents, and increased the organization of study data.

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