IDEA Details

IDEA Details

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.   Of utmost importance is its ability to enable “just-in-time” inventory management which has been demonstrated to be a key to success in industry today.

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

The development of IDEA© was supported by a grant from the National Cancer Institute, Small Business Innovations Research (SBIR) program.

OVERVIEW OF CAPABILITIES

Pharmacy

Agent Ordering:   Permits the ordering of investigational agents to be aligned with the patient and protocol using a variety of scalable order forms, email, and online ordering.

Receive Agent:   Updates agents on order.  Identifies those back-ordered, re-ordered, and abandoned.  Updates Drug Accountability Records (DARs) and notifies the requesting individual of agent arrival.

Dispense Agent:  Provides comprehensive capability related to the dispensing of agents including patients receiving treatment, agent availability, and projection of future ordering needs.

Transfer Agent:  Allows for the transfer of an agent among protocols and locations (as permitted 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.

Protocols

Base Data:  Captures the national identifier, sponsor, disease site, protocol title, and local coordinator.

Schema Definitions:  Establishes a segment of treatment time (weeks/days, months/years) capable of unlimited duration; supports multiple overlay segments for each protocol arm.

Treatment Agents:  Allows for the selection of the agent by generic or commercial name.  Determines the ability of the agent to be “date adjusted (cascaded)” on patient schedules.  Assigns the agent as provided or not provided, patient specific or not patient specific.

Establish Treatment Cycles:  Simplifies establishment of treatment cycles through check off mechanism.  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 displayed page.

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.

Patients

Demographics:  User enters a patient name and zip code.  IDEA© 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, the event is automatically logged in the patient schedule.  If treatment delay is required, the user simply selects the starting point of the delay and reassigns the new treatment date.  IDEA© automatically “cascades” the patient schedule to accommodate the delay.

Reports

The comprehensive Reports module allows ultimate flexibility and vast options for generating reports for every conceivable need related to patients, protocols, pharmacy inventory management, and staff involvement.

Alignment with National Cancer Institute Clinical Trials Requirements 

In 1997 DDOTS began working on the development of pharmacy management software for institutions participating in National Cancer Institute trials.   Collaboration with members of the NCI’s Pharmacy Management Branch at that time enhanced DDOTS’ understanding of the NCI’s issues and future directions required of investigational drug management systems.

IDEA© incorporates numerous elements to manage the entire process of drug ordering and dispensing, drug tracking, and NCI reporting:

The Drug Order Module permits the logging of a drug to be aligned with the patient and protocol.

The Receive Drug/Agent Module updates drugs on order, identifies those back ordered, and updates the Drug Accountability Records (DARs) in NCI format.

The Transfer Module allows the potential to transfer drugs among protocols and locations and then evaluates the ramifications of a transfer on inventory.  This capability was of particular interest to the NCI in order to streamline or eliminate the process of shipping, returning, and re-shipping investigational drugs.

The Returns Module tracks drug returned to the NCI with email availability for notification of returns, including NCI return authorization numbers.

A comprehensive Reports Module includes an accountability report through which the NCI and/or research bases can perform random audits of research site drug usage and inventories.

Benefits

IDEA© is a user-friendly, intuitive software program that employs a common language developed and utilized by clinical research personnel including pharmacists.    The beneficial impact of IDEA© on the quality of the entire inventory management process is irrefutable.   It streamlines work process and facilitates communication between the pharmacist and research staff.

SUPPORT SERVICES

DDOTS offers full support services including:

Installation and an individualized roll-out plan.  The IDEA© IT team works with you each step of the way to design and implement an installation plan that considers what is best for you, from research program, pharmacy staff to your institution's IT departmental needs.

On-site training  as well as individualized web-based training.  Recognizing that it is never easy to adapt to new software irrespective of the “user friendliness” of the program, DDOTS conducts on-site training for staff concurrent with the installation of IDEA© to provide the support necessary for a successful transition.  Web-site training is available on an ongoing basis.

Unrivaled technical support.  DDOTS recognizes that critical to our success has been our commitment to provide the best technical support in the field – and in this regard we remain steadfast.  We are resolute in our promise to provide a quick response when needed – staff should not have to wait 24 or 48 hours to get an answer.   Just ask IDEA© users; we’ll be happy to provide a list of references.   And there is never any charge for technical support.

AFFORDABILITY

Today’s health care milieu is one of unmitigated cost containment pressures irrespective of top notch technology to aid work product efficiency and effectiveness.  DDOTS understands the institutional need to limit capital outlay and has designed its clinical trials software pricing accordingly.

It can be argued that IDEA© is the most affordable investigational drug pharmacy management program on the market.  There is no purchase required.  

If IDEA© is installed as a stand-alone program, the annual licensing fee for an organization is a flat $9,500.   However, the annual licensing fee is reduced to $3,000 for institutions also utilizing DDOTS’ CREDIT© clinical trials management system.  As always, the number of affiliates and staff covered by one license is unlimited.