DDOTS

CREDIT

research software for comprehensive clinical trial management

CREDIT clinical trials management system (CTMS) is a complete web-based system for overall management of clinical trials including an eRegulatory Binder.

Manage patients

track recruitment and screening

generate individual calendars based on protocol schema

record deviations and serious adverse events

capture patient visits and events including sponsor invoice-able values

track re-consenting or patient notification due to protocol revision

archive patients no longer on study

Manage protocols

capture protocol details with full reporting

easily build protocol arms (schema) with complex design

eRegulatory module to track IRB review dates, actions and documents

key personnel tracking with licensure/training management

track monitor visits and audits including ability to provide remote access

Manage financials

invoicing, sponsor payment tracking and allocation – ALWAYS know what you have earned and what you are due

study start-up costs

track payments to third parties

tools for managing billing compliance, financial analysis and coverage analysis

extensive suite of financial reports

Reports

over 100 standard reports, each fully configurable

patient accruals, protocol status, financial tracking, staff time and effort, and more…

export reports to Excel

set custom report settings memory per user

report output restricted based on user access permissions

custom reports built at no additional cost.

IRBANA

research software for Institutional Review Board management

IRBANA is a web-based submission, review and document management system for Institutional Review Board (IRB) staff and reviewers.

Electronic submissions

easily enter IRB submissions for a new study, continuing review, revisions/amendments, key personnel changes, etc.

complete document managment

facilitate communication between researchers and IRB staff

automatic email notifications for approval process status updates

Manage protocols

capture protocol details including status with full reporting

track IRB review dates and actions including revisions and amendments

document storage and access

key personnel tracking with licensure/training management

Agenda, minutes, approvals

create IRB meeting agenda automatically based on configurable design

easily separate submissions into appropriate sections based on type of submission, type of review, and other criteria

create meeting minutes, update actions and record voting in seconds

store approval letter templates and quickly generate letters in Word or pdf format

IRB reviewers

email notification when protocol/documents are ready for review

one-screen display of all protocols and documents for your review

record comments directly into IRBANA

notify IRB staff automatically when review has been completed​.

IDEA

research software for investigational pharmacy management

IDEA is a comprehensive web-based system for all aspects of investigational drug inventory management and dispensing.

Patient safety

standardized process for managing investigational agent to improve patient safety while maintaining regulatory compliance

safeguards to prevent selection of expired or quarantined agents when dispensing

reduce the risk of dispensing to patients not enrolled on a study

Dispensing

capture complete dispense details and record in the DARF

prevent dispensing of drugs that will expire within the prescribed treatment period by evaluating dispense date, supply amount and expiration date

track dispense details including drug thaw time, time of reconstitution, and temperature reading at time of reconstitution​

Centralized inventory management

centralized electronic management of investigational agents offers improved legibility, reduced paperwork/handwriting and streamlined inventory management to provide pharmacists more time for valuable work and patient care

provides standardized DARFs that capture required transactions (receive, dispense, return and destroy) to ensure consistency and compliance with applicable regulations

DARFs can be customized using filters yet still maintain a standard appearance for all protocols regardless of sponsor

automates processes to provide accurate management and documentation of agent receipt, storage, dispensing, returns and final disposition which improves overall pharmacy efficiency

provides common access to protocol, patient and agent information, eliminating duplicate or multiple spreadsheets maintained by individual users – time savings for staff and elimination of paper recordkeeping greatly reduces waste

Order, receive, transport

ordering of agents is aligned with the patient and protocol using a variety of scalable order forms, email and online ordering

able to track processed orders via Agent Order Report (queue)

upon receival, IDEA captures agent details, including exact date/time received, pharmacy-generated lot numbers, container type, quantity, unit, method, packaging, supplying agency, storage location, etc.

updates drug accountability records (DARFs) and notifies requesting user of agent arrival

can receive agent at control/central location and transport to satellite locations with separate DARFs.

BIOSPEC

research software for biospecimen repository management

BIOSPEC is a web-based biospecimen inventory system for programs involved in the management of bio-repositories.

Specimen inventory management

Assign unique identification number to each specimen and capture relevant clinical data

Catalog specimens to participants, protocols, departments, investigators, institutions, disease sites, anatomical locations, etc.

Divide samples into new specimens with new unique ID and associated data

Track specimen from collection through freezing/thawing and possible destruction

HIPAA compliant with ability to de-identify data

Highly configurable repository

Manage multiple biospecimen repositories

Collect specimens per protocol calendar timepoints or via single event timepoint (e.g. tissue collection, blood draw)

Track/upload consents and other documents

Design freezer/storage container configuration to mimic physical storage

​Comprehensive reporting

Easily query specimen repository for specific sample type

Multiple configurable reports for inventory, QA, consents, manifest creation/tracking, invoice creation/tracking, and more.

Specimen manifests and invoicing/payment tracking

Manage invoicing for specimen distribution and payment tracking.