Streamlining Research Study Process for Contract Research Organization

Case Study: Custom Dosing Application

Background:

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. Additionally, they used spreadsheets to record and collect the data for Pharmacology and In Vivo studies. Because of the different needs of the studies, the organization was in need of a comprehensive study management system. Therefore, they contacted Aciron to develop a study management system that would allow users to manage their studies and operations digitally.

How We Added Value:

Aciron performed 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. Next, we developed a roadmap for the application so that it would work for all study types.

Aciron and the client determined a phased approach to the development of the custom dosing data collection application would be best. This approach would enable the client to use the system for its most critical needs quickly. In addition, it encourages large user adoption and engagement without much disruption to end users.

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. Given the organizations’ studies’ complex nature, the clickable and visual prototype allowed Aciron to walk the study team through an entire study lifecycle in the system. Additionally, it 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. Through brainstorming modifications, the client was able to provide feedback for the design and development process. Using the established requirement gathered, strategy, and design for the system update, Aciron developed a customized system for the client.

Results:

Aciron developed a custom study management system. The system features a dosing and collection schedule feeder, which automatically calculates all upcoming doses and collections based on the needs of each participant. The system allows study and project managers to have the entire study protocol and current status at their fingertips. In addition, study and project managers can generate reports with the click of a button.

Additional features of the application include:

  • Study Observation Form, which allows users to record their observations digitally and aggregate these records into one location 
  • 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 application standardized the client’s study creation process and automated the dosing and collections process. Thus, improving researchers’ productivity.

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Streamlining Research Study Process for Contract Research Organization

Case Study: Custom Dosing Application

Background:

An innovative contract research organization (CRO) that conducts bioanalytical and pharmaceutical testing services for the biotech and pharmaceutical industries were 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. Additionally, they used spreadsheets to record and collect the data for Pharmacology and In Vivo studies. Because of the different needs of the studies, the organization was in need of a comprehensive study management system. Therefore, they contacted Aciron to develop a study management system that would allow users to manage their studies and operations digitally.

How We Added Value:

Aciron performed 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. Next, we developed a roadmap for the application so that it would work for all study types.

Aciron and the client determined a phased approach to the development of the custom dosing data collection application would be best. This approach would enable the client to use the system for its most critical needs quickly. In addition, it encourages large user adoption and engagement without much disruption to end users.

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. Given the organizations’ studies’ complex nature, the clickable and visual prototype allowed Aciron to walk the study team through an entire study lifecycle in the system. Additionally, it 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. Through brainstorming modifications, the client was able to provide feedback for the design and development process. Using the established requirement gathered, strategy, and design for the system update, Aciron developed a customized system for the client.

Results:

Aciron developed a custom study management system. The system features a dosing and collection schedule feeder, which automatically calculates all upcoming doses and collections based on the needs of each participant. The system allows study and project managers to have the entire study protocol and current status at their fingertips. In addition, study and project managers can generate 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 
  • 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 application standardized the client’s study creation process and automated the dosing and collections process. Thus, improving researchers’ productivity.

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