Product Overview
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©

Web-based Software for

Investigational Drug Inventory Management

Investigational Drug Environmental Accountability (IDEA©) is a comprehensive Web-based program for all aspects of investigational drug inventory management and dispensing.  It incorporates elements for inventory control and audit performance  required by clinical trials sponsoring organizations, including the National Cancer Institute.

Whereas most drug inventory systems only provide information as to inventory on hand, IDEA©  allows clinical research sites the ability to have "look ahead" capability in order to plan for future inventory needs and be able to meet those needs in a variety of ways.  This extraordinary feature distinguishes IDEA© from any other drug inventory system on the market today.

IDEA© may be utilized as a stand-alone pharmacy system or incorporated as a module into CREDIT©, the clinical trials administration and patient scheduling software developed by DDOTS.

The development of IDEA© Web-based software was supported by Grant No. 1U43CA78105-01 from the National Cancer Institute, Small Business Innovations Research program.  Its contents are solely the responsibility of DDOTS, Inc. and do not necessarily represent the official views of the National Cancer Institute.

The capabilities of IDEA© are highlighted as follows:

PHARMACY

	Agent Ordering Permits the ordering of investigational agent to be aligned with the patient and protocol utilizing a variety of scalable ordering forms and email format.
	Receive Agent  Updates agents on order. Identifies those back-ordered, re-ordered, and abandoned. Updates Drug Accountability Records (DAR) and notifies the requesting nurse of agent arrival.
	Dispense Agent Provides comprehensive capability related to the dispensing of agents including lists of patients receiving treatment, agent availability, projection of future ordering needs.
	Transfer Agent Allows for transfer agent among protocols and locations (as allowed by the sponsoring organization) and then evaluates the ramifications of a transfer on current inventories.
	Waste Agent Provides the ability to document drug waste and update the DAR inventory per patient or protocol.
	Agent Return Request Tracks agents on hold awaiting return authorization from the supplying agency.
	Return Confirmation Notifies the supplying agency of the agent being returned and method of transit.
	View Inventory Maintains exacting inventory and location per protocol, agent.
	Communications Generates important internal emails to notify selected staff of important Pharmacy activities and impending shortages.

DRUG ACCOUNTABILITY RECORDS (DAR)

	Automatically Recorded Seamlessly records user activities by automatically updating DARs via Pharmacist activities.
	Viewable per Patient, Protocol, Agent  Allows for simple navigation between various views of a compound DAR
	Pharmacy Specific Tracks DARs for an unlimited number of pharmacies (Inpatient, Outpatient...etc.)
	Memo Fields Provides an easy way to attach a narrative to each and every DAR entry.
	Security and Notation Entries Simplifies adding a narrative to any DAR without needing to create an "Event Entry".  The user of author owns all notations and memos.  Other users may view, but not edit these entries.

PROTOCOLS

	Base Data Captures the National identifier, Sponsor, Disease Site, Title and Local Coordinator.
	Arm Identifiers  Tag any protocol arm with A-Z, 1-26.
	Schema Definitions Establishes a segment of treatment time (Weeks/Days, Months/Years) capable of unlimited duration. Supports multiple overlay segments for each arm.
	Treatment Agents Allows for the selection of  the agent by generic or formal name. Determines if the agent can be "date adjusted (cascaded)" on patient schedules.  Assigns the agent as provided or not, patient specific or not.
	Establish Treatment Cycles Simplifies establishment of treatment cycles through check off  of appropriate Day, Week, Month, or Year the treatment is to be given.  For example, a treatment cycle for  an agent to be given on Day 1, every 35 days x 5 cycles only requires the user to place 5 checks in boxes on the displayed page.

PATIENTS

	Demographics User enters a patient name and zip code. IDEA(c) selects the City, State and telephone area code.  Provides capability to load in a digital photograph of the patient.  All standard demographics are allowed including a notepad area.
	Protocol Assignment  User selects a protocol and arm for a patient and enters the date treatment begins. IDEA© creates the entire schedule from the master protocol schema.
	Schedule Tracking As treatments occur in the Pharmacy module, the event is automatically logged in the patient schedule. If treatment delay is required, simply select the starting point of the delay and re-assign the new date. IDEA© automatically "Cascades" the patient schedule to accommodate the delay.

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Who should use IDEA©?

	All research sites (university hospitals, community hospitals) conducting clinical trials involving pharmaceutical agents
	National Cancer Institute research sites including Comprehensive Cancer Centers,  Community Clinical Oncology Programs (CCOPs) and research bases
	All Divisions of the National Institutes of Health (NIH ) conducting research involving pharmaceutical agents
	Pharmaceutical companies and their clinical research sites
	Physician practices which are involved in clinical trials

Why is IDEA© so important?

	Inaccurate investigational agent tracking does exist. This is greatly problematic for the National Institutes of Health (NIH,) including  the National Cancer Institute (NCI,) and other organizations conducting clinical research. Consequences of improper tracking include potential invalid research results, cessation of funding by sponsoring agencies, and potential patient safety issues.
	It is critical to have a solution for poor accountability. The implications for an inefficient agent tracking system are costly. Agents that are left to expire and returned to the sponsor are of major concern. Exhausting the supply of an agent that is required for current treatment often results in the substitution of a commercial agent. This can invalidate research results and is one of the core issues during an audit.
	IDEA© has been demonstrated to be a vital tool for the busy pharmacy involved in clinical trials. Because IDEA© is "Intranet Browser" based, it can be used on any platform that supports Internet Explorer or Netscape.

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Specifications:

	Windows 2000/2003 Server
	SQL Server 2000
	WebEditPro 4.0 +
	Internet Explorer 6.x
	ColdFusionMX 7.x

	1ghz Processor
	1gb RAM
	5gb Drive Space

	If Windows based, Windows 98, Windows 2000, Windows XP
	450mhz Processor
	64mb RAM (preferred 128mb)
	Internet Explorer 6.x