A Clinical Trial Management System (CTMS) is the solution that many companies
adopt as a means of providing a central database for all non-clinical (and
some clinical) data, as well as providing all the tools for entering and
reporting this data.
The Perceptive solution is IMPACT, the world's most utilized enterprise-wide
CTMS. IMPACT currently has over 25,000 users worldwide.
The Perceptive Solution
IMPACT (International Management Package for Administration of Clinical Trials)
is a highly flexible, web based, proven CTMS. It caters to all types of clinical trials,
from large multi-national trials to single site, investigator-sponsored protocols.
The IMPACT solution provides planning and tracking support for all aspects of a trial
and consolidates all the information from various collection points into a single
source.
IMPACT is a modular system, providing for
different aspects of clinical trial management.
IMPACT Modules
IMPACT Progress - planning and tracking
information about all projects and trials, 
through the countries and sites involved, to details of the patients and their
progress through the trial. Details of the studies may be held with timelines,
enrolment summaries and responsibilities.
IMPACT MyAlerts - provides users
with a presentation of 'critical' IMPACT data from which they can navigate
to further details and then to the actual data in the main IMPACT system.
IMPACT Planning - additional flexibility and sophistication of planning and tracking,
using a two way link with Microsoft® Project.
IMPACT MySites - supports most all on-line and off-line monitoring visit activities, and the collection
of associated management data during site visits by field monitors.
IMPACT MyTrials - the link between the clinical research department and the investigative site that enhances site loyalty, reduces administrative overhead, and bridges the gap between the trial manager and the site.
IMPACT Clinical Cost Tracking - planning, budgeting,
projection and tracking of costs associated with clinical trials. IMPACT
supports full multi-currency operation.
IMPACT Clinical Supplies Tracking -
forecasting, dispatching and tracking supplies.
IMPACT INVESTIGATOR - centralized
source of investigator information to help with selection of the best investigators
and sites for a study.
Features
- Open database, with a complete set of APIs (Application Program Interfaces)
- 21 CFR Part 11 compliance
- Comprehensive audit trailing
- Investigator profiling, allowing searches on therapeutic specialties, survey data, via geographic location, etc.
- Database synchronization, allowing other systems to update patient enrollment Data even when monitors are on site
- Totally flexible currency usage using highly accurate triangulated currency conversions
- Ad-hoc reporting via use of denormalized reporting tables so that any reporting tool can easily access the database
- Strong workflow (what should I do next?) construct throughout the product
- User group, solidly supported, meets twice per year
- 25,000 users up and running across the world
- Proven support desk and maintenance approach
Benefits
Zero Footprint
A zero footprint means that the web version of IMPACT does not need any software on a laptop. This removes most validation and IT support concerns as well as the need for costly hardware upgrades.
Unlike other CTMS solutions, IMPACT's web operation is optimized for
operating over a wide area network, so that no matter how many users
there is no response-time degradation.
Rich Functionality
Proven to be able to cope with all sponsor
trials, many users find more and more in IMPACT the more they use it.
User committees help define new functionality allowing the product
to remain in line with user requirements.
Training and Implementation
Unique and proven implementation methodology
via a series of well-designed workshops limits the cost to get up and
running.
Perceptive personnel have clinical backgrounds, which means that IMPACT can be implemented without the use of 3rd party consulting costs.
The IMPACT solution means longevity of support,
and a process of continuous enhancements.
