Logos Technologies - Electronic Data Capture solution

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Life science organisations have been using ALPHADAS^® on live studies for over a decade. Logos Technologies solutions are becoming an established way of conducting Phase I clinical trials.
The majority of EDC vendors can not support the unique way Phase I trials are conducted or provide a business model that will suit small studies that often require frequent last minute changes. Typically this has caused many pharmaceutical companies to stick with pen and paper based methods. Logos Technologies is probably the only EDC vendor who can provide a cost effective solution for your Phase I trials.

ALPHADAS®, the only Electronic Data Capture solution designed specifically
for Phase I Clinical Trials.

Typically Phase I trials are conducted on small subject populations and often only at one site. Studies can be broken down into multiple cohorts where the majority of data is collected in the first 48 hours. ALPHADAS provides Sponsors and Sites with the complete electronic solution.
ALPHADAS will dramatically reduce queries through the use of real-time edit checks and direct data capture. The schedule driven system will assist investigators and their staff to collect accurate data at the point of collection reducing errors inherent

Key benefits of ALPHADAS:
■ Faster data - quicker database lock.
■ Reduced costs throughout the whole
Phase I process.
■ Reduce time to complete a Phase I study.
■ “Go / No go” decisions made earlier.
■ Increase subject safety - review data e.g. vital sign trends in real-time.
■ Manage or run more studies
with less resource.
■ Serious Adverse Event notification
and monitoring.
■ Study progress monitoring.
■ Collect data online, off line, over the air, using a notebook, Tablet PC, PDA or any combination.
■ Allow your subject to collect data at home using a PDA or online.
■ Remove the need for source data
verification.
■ Make rapid changes to your study even after it’s started.

with manual operation and accelerating
the procedure.

The ALPHADAS Web Portal™ will provide
secure real time access to all study
information, in particular Sponsors and
Investigators will be armed with faster
decision making data mid-study helping
to determine a drug’s safety and efficacy.
This will also allow Sponsors to stop
unsuccessful compounds sooner and
to bring the successful ones to market
more quickly.

■ All Phase I data in one location -
Laboratory data, images, scans, etc.
■ Increase protocol compliance - reduce
late or missed tasks from occurring.
■ Bar-coded labelling - track samples from draw to dispatch.
■ Bi-directional data interface with your
central Laboratory - make paper
Laboratory requests a thing of the past.
■ Collect data direct from instrumentation - ECGs, Vital Signs etc.
■ Configure studies in days using flexible, rapid designer wizards.
■ Schedule and resource driven -
never miss a task.
■ Complies with industry standards and
guidelines including FDA 21 CFR part 11.
■ Integrates fully with Logos Technologies Phase I Site Tool Kit.
■ ASP and enterprise versions available
including full knowledge transfer.





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	ALPHADAS has been designed for real time “eSource” data collection. Where this is not possible data can be collected through a configurable eCRF to match your source workbooks which will reduce errors inherent to data entry. Unlike many EDC systems available today ALPHADAS has been designed with the Investigator in mind.




	ALPHADAS Express Logos Technologies can provide a site with a Turnkey ‘out of the Box’ validated hardware and software solution on a study by study basis. ALPHADAS Express can be deployed as a fully out-sourced package - Logos Technologies will setup your study and train the Investigator’s staff to collect data in real time. Logos Technologies can alternatively train your staff how to set up your own specialised Phase I studies using easy to use study designer wizards.

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