Study Management System for a Pharmaceutical Research Organization

How Aciron does it

To start, this contract research organization (CRO) conducted bioanalytical and pharmaceutical testing services for the biotech and pharmaceutical industries. Overall, they were having issues managing their high volume of multi-day studies. This research organization was looking for a new study management system.

Services

Technologies

The challenge

Firstly, 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 the data for Pharmacology and In Vivo studies. But, because of the different needs of the studies, the organization needed 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.

Our approach

Secondly, Aciron performed rigorous hands-on requirements gathering activities in order to better understand the needs of the client. Then, we 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.

Most importantly, Aciron and the client determined a phased approach. This was needed for the development of the custom dosing data collection application. For example, 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, however, without much disruption to end users.

The Aciron team developed storyboards to visually articulate the various scenarios that the study coordinators and scientists would encounter. Given the organizations’ studies’ complex nature, the clickable and visual prototype allowed Aciron to walk the study team through an entire study lifecycle. Additionally, it enabled the client to provide feedback before any code was actually written.

As a result, Aciron 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 development process. Overall, using the established strategy and design for the system update, Aciron developed a customized system for the client.

Solution

In conclusion, Aciron developed a custom study management system. The system features a dosing and collection schedule feeder. In other words, it automatically calculates all upcoming doses and collections based on each participant.

Moreover, the system allows project managers to control 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

Transform

Utilizing a flexible, agile methodology Aciron designed the system to allow for updates and enhancements to be made over time. In conclusion, the custom application standardized the client’s study creation process. It automated the dosing and collections process. Thus, improving researchers’ productivity.

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