Aspect Trials is an innovative and state-of-the-art electronic system
for the management and administration of clinical trials. Aspect Trials has been designed to provide
a more sophisticated solution than those provided by current alternative techniques.
Aspect Trials means clinical trials automation. Featuring intelligent case report
forms, task workflow sequencing, and robust security, Aspect Trials offers a comprehensive
solution for the administration of multiple trials within a single integrated environment.
Its user-friendly, Web-based data collection interface is the portal to a powerful
and flexible software engine that continuously monitors the complete clinical trial
process. Aspect Trials empowers clinical researchers to achieve accurate, efficient,
effective clinical trials.
Collection Station
The Aspect Trials Collection Station provides a window through which subject data
is easily entered. Accessed from any modern operating system using a standard Web
browser, it combines strong security and privacy protection mechanisms with an easy-to-use
interface where clinicians and users enroll and select subjects, enter and review
case report forms, and recognize possible adverse events. The Key features of the
Collection Station are briefly detailed in the table below:
Aspect Trials supports the concurrent management of multiple trials. Through a single,
common user environment, clinicians can enroll subjects, and enter and review data,
for different studies. Trials can be configured to be run in multiple sites around
the world, enabling the instantaneous transmission of data from any point of participant
contact to a central trial data repository. For locations where access to the Internet
is unavailable or unfeasible, Aspect Trials provides offline data collection with
advanced synchronization using highly portable devices such as Tablet PCs.
When working with a subject, the clinician is shown the specific set of tasks to
be performed at a particular visit, as mandated by the trial protocol. This automated
task sequencing enables stricter protocol compliance and minimizes deviations. As
clinicians enter collected data and indicate the completion of each task, Aspect
Trial immediately computes the next tasks to be performed with the same subject
and advises the user accordingly.
Case report forms (CRFs) and data entry screens contain underlying technology that
minimizes errors and increases clinician efficiency by enabling automatic on-the-fly
calculations, consistency verification, and conditional data collection. Responses
within a form or in other forms previously filled for a patient are used to determine
data validity and to require or disallow information entry. Pre-defined calculations
provide immediate feedback to the user and help eliminate errors and inconsistencies.
Adverse events are detected automatically through the continuous and unobtrusive
analysis of collected data, or directly reported by clinicians and users. Upon the
occurrence of an adverse event, screen and e-mail alerts are presented to the trial
managers or clinical directors, and tasks for the subject are suspended until appropriately
authorized individuals acknowledge the adverse event and decide on a course of action.
Management Console
Trial managers and principal investigators use the Aspect Trials Management Console
to set up, start, and stop clinical trials, to establish security and privacy policies
for every user, and to monitor and evaluate the overall performance and execution
of all trials. The key features of the Management Console are listed below:
User authentication and access control mechanisms embedded in Aspect Trials help
ensure that information is entered and accessed only by authorized personnel. Each
user is specifically assigned a set of tasks to be performed on a specific set of
subjects at a specific trial site, preventing both inadvertent errors and malicious
tampering. Transmissions of data through local or Web connections are always encrypted.
Aspect Trials is designed to comply with all security and privacy standards, including
the Health Insurance Portability and Accountability Act (HIPAA), the U.S. Code of
Federal Regulations on Electronic Records (21 CFR Part 11), and the guidance documents
from the International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH).
Close tracking and monitoring of enrollment levels, study progress, and protocol
compliance is critical for the efficiency and even success of a clinical trial.
Through the Aspect Trials Console, the trial manager or principal investigator reviews
subjects by trial or by site, verifies and corrects information in collected case
report forms, includes or excludes subjects from any trial within the system, and
makes decisions regarding adverse events or other abnormalities in trials. Reports
detailing the progress of each trial are easily created and viewed.
Architect
The Aspect Trials Architect is a graphical toolset that assists the clinical investigator
in designing a clinical trial. It provides intuitive graphical user interfaces to
create and modify the trial protocol sequences and the case report forms and entry
screens.
The Aspect Trials Architect allows for drag-and-drop protocol design using graphical
representations of actions, tasks, and decisions to define the workflow of a study.
The graphical interface provides trial developers with the ability to easily describe
and visualize the complex sequence of events required in a clinical trial. Tasks
are associated with case report forms and defined in sequences, while decision points
indicate either the automatic selection of a path based on some previously collected
or calculated value, or the need of a manual choice by an authorized user. Parallelism
and iterations can be easily configured, and tasks can be grouped together conforming
visits. Protocols defined through the Aspect Trials Architect are realized and saved
in XML, enabling protocol reuse and refinement.
Case report forms and data entry screens are easily created in the Aspect Trials
Architect through a comprehensive interface, where the trial developer designs the
data capture mechanisms and the look-and-feel of each form, inserts intelligent
expressions and instructions, and defines versions in different languages. Standardized
forms are easily saved and reused at different stages within a trial protocol.
Aspect Trials
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Key Features
- Collection Station
- Management Console
- Architect
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