IMPACTTM CTMS Services
Perceptive Informatics provides extensive services coupled with its industry leading IMPACT Clinical Trial Management System. For a new customer or one who would like to take advantage of new features, functionality with an upgrade, the ISG team has the expertise to ensure your project is a success.
Deployment Services
Perceptive’s ISG team includes consultants with many years of experience using the IMPACT application. Project managers can be involved from an onsite or offsite basis, coordinating with sponsor’s internal team. Beginning any project is an initial determination of the sponsor’s needs. This business analysis drives the implementation of IMPACT, ensuring best value and success with the product. Technical consultants provide extensive installation, configuration and integration expertise, with expert knowledge of the application, modules, and data infrastructure, as well as CDISC data models, often used in integrating and exporting scenarios.
Validation Services
Any validation exercise is fundamentally tied to the sponsors Quality System. Validation materials are created, aligned with product release schedules, providing a foundation of standard Installation, Operational, and Performance Qualification fundamentals. Expert validation consultants are on staff to support any client specific needs, customizing, executing and supporting validation activities as needed. The ISG team has provided sample materials, through complete validation packaging, as defined by such standards as 21CFR Part 11 and GAMP 4 Computer System Validation models. These may include Master Validation Planning, Requirements Traceability Matrices, Qualification Tests, and Summary Reporting.
Training
Also coupled with the product releases, are Training materials. For each IMPACT release, core modules are thoroughly documented in base material, that can be easily customized to customer and role based scenarios. The extensive training program includes Train the Trainer, role based end user training, Administrator training, as well as modules that can be incorporated into the application’s online Help system. Computer Based Training, supporting the need to prove trainee’s proficiency with the tools, are also supported.
Hosting IMPACT – Application Service Provider
Companies may want to adopt an Application Services Provider (ASP) model. In this approach, Perceptive hosts the application on the customer’s behalf – either as an interim solution or as a convenient long term method of delivery. Case studies are available, highlighted the benefits and value of this ASP model.
