Powerful Software – Proven Results

Over the last decade we have witnessed first-hand the changing demands of early phase clinical trials. Early phase EDC is continually evolving and we remain at the forefront of that evolution, working with and learning from our clients.

ALPHADAS can be installed on-site or clients can use Instem’s SaaS (Software-as-a-Service) model to access ALPHADAS offering simpler, more cost effective ways to provide software functionality, maintenance, and support over the Internet. Instem’s professionally managed cloud platforms are run from centralized state-of-the-art data centers, which is being used by clients around the world.

Operational Efficiencies

  • End-to-end software solution optimizes resources
  • Operational savings throughout the business
    • Clinic floor
    • Data management – no transcription
    • Recruitment and administration
    • Laboratory
  • Enables efficient and optimal resource planning
ALPHADAS Modules

“Following a thorough evaluation of several software solutions, and after visiting with clients of each vendor under consideration, it was clear that ALPHADAS by Instem would not only be replacing our existing system, but was the one solution that would truly be providing us with the platform we need to help our clients succeed” James Dickinson, NUVISAN

Data is captured quicker, cleaner and more efficiently

  • Direct from source instrumentation (no transcription)
  • Data captured at bedside – errors immediately addressed
  • Virtually eliminates data queries
  • Enhances compliance management
  • Remote real time data monitoring and review
  • Unexpected events added immediately

Minimizes deviations and costs

  • Organizes who, what, where, for how long
  • Provision of complete management data – ALPHADAS Dashboard™
  • Complete audit trail
  • Drives compliance management
  • Chain of custody for samples
  • Regulatory compliant

Used in live clinical trials for over a decade

  • Over 30 sites across 4 continents currently have ALPHADAS
  • Over 1,600 clinical beds
  • Clients range from top 10 pharma to independent CRO’s to Nutraceutical sites
  • Strong references upon request 

Unsurpassed experience in successful implementations

  • Successful implementations across four continents
  • Decades of both software and clinical experience within the team
  • Currently supporting sites across 15 time zones

We have been end users – we have gone through the process

  • Bespoke training programs to align with your operational needs
  • The ALPHADAS Academy™ is a full syllabus of varied and interactive training modules
  • Support materials include full suite of User Guides and training videos
  • Understanding and sympathetic trainers – ex-clinic staff – real and relevant experience
  • Super Users quickly established to internalize the training 

ALPHADAS - how it works

Fact Sheet

ALPHADAS - how it works

Fact Sheet

ALPHADAS Modules

CTMS

CTMS

Our Clinically-driven site automation tools help organizations better manage and streamline the clinical trial process. Resources are tightly managed and key data entered only once but used for multiple purpose.

The Wins:

Save time, improve efficiency, enhance client service, and realize a “Day 1” ROI

Key Features

  • Study Subject Management
    • Recruitment
    • Screening
    • Seamless text messaging interface from within ALPHADAS
    • Study Subject Database instantly and dynamically searchable across numerous fields
  • Study Builder
    • Study schedules
  • Staff and Resource Scheduler
  • Master Document Creation
    • Protocol
    • CRF
  • Barcode generator
    • Barcode generation and management
  • Subject Payment module – automatically control who is paid, when and why – both planned and ad-hoc

CTMS

Subject Payments

Key Highlights

  • Efficient database communication – mail merge, document control and SMS text Message Volunteers
  • Dynamic, instantly searchable Study Subject Database
  • Seamless Migration from existing databases
  • Studies configured using rapid, flexible designer wizards
  • Master Document Creation
  • Designed to support and streamline clinical processes
  • ALPHADAS Ward Screen display – driving clinical excellence

Study Subject Management

  • Manages recruitment needs across all studies
  • Ensures subjects meet the required criteria for a study prior to being assigned an appointment
  • Places recruited subjects onto specific study sessions
  • Reports on status throughout a study – able to view captured data and audit trail for current study
  • Customize the volunteer database to meet site specific needs
  • Instantly search for individuals or groups of volunteers that meet a certain criteria
  • Ability to text message individual or many volunteers at once
  • Export query results to Excel and/or mail merge in Word
  • Association of letters to be sent to subjects, groups of subjects, or GPs
  • Key aspects can be customized, such as the view, data fields, categories and site specific fields

Schedule Designer

Enables;

  • Creation of study schedules
    • Study tasks added from previously created libraries of events and questions
  • Events are easily scheduled pre or post the reference dose or other event(s)
  • Master Document Creation
    • CRF/eCRF
    • Protocol
  • Staff and Resource Scheduler

Barcode Management

  • Every event within ALPHADAS is given a unique barcode enabling robust and dynamic process and quality controls
  • Either ALPHADAS or sponsor barcodes can be used
  • Ability to print several types of barcode labels before, during and after a study
  • Ability to reprint labels at any time
  • Labels can be custom generated
  • Integrates with Sample Tracking to enable samples to be tracked from draw to despatch 

Services and Apps

  • Seamless Migration from existing study subject databases
    • Experienced team worked on numerous proprietary and commercially available databases
  • ALPHADAS Ward Screen display – driving clinical excellence
    • Events displayed like an ‘airport departures’ screen

Sample Tracking

Sample Tracking

Customizable and responsive chain of custody from draw to dispatch, integrating with Central Labs.

Powerful Product Features

  • Track from draw to dispatch as individual samples or in batches
  • Seamlessly create & manage central lab requisitions from within ALPHADAS
  • Barcode Driven
  • Simple & complex paths – can be edited spontaneously
  • Bi Directional Integration with Central Labs
  • View overall & step specific processing instructions
  • Comprehensive reports - Sample history, storage, shipment manifest reports…

Sample Tracking

eSource Data Capture

eSource Data Capture

Using ALPHADAS for your early phase clinical data collection saves time, money & enhances data quality. 

Market Leading Functionality

The ALPHADAS Data capture tool, QDAQ, has market leading functionality that offers clear and direct enhancements to data quality & efficiencies for both the sites and sponsors in time and resource.

True Offline Redundancy, guaranteeing uninterrupted reliable data collection – regardless of connectivity

  • Web App data collection enables data collection independent of connectivity status
  • Also enables secure & compliant integration with medical devices

Reduced data entry and management

  • Study data entered only once, at source, whether that be at the bedside, eSource or remotely on patient diary
  • Available for immediate review and remote monitoring in a variety of platforms – Rave, SAS…

Virtual elimination of onsite monitoring

  • Time and resource savings
  • Optimizing data quality

Reduced source document verification

  • ALPHADAS is the source system, when data is not first recorded to other media.

Harmonized trials across multiple sites

  • ALPHADAS works across multiple studies, sites, sponsors, groups and subjects, aiding collaboration across multiple or partnering sites.

Enhanced decision making

  • ALPHADAS offers real-time visibility to cleaner data, validated at point of collection

QDAQ

Bedside Data Collection;

  • Built using latest Web App technology
  • Reliable both on and off-line – local redundancy – data collection continues regardless of internet or local network failures
  • Data available for immediate review and reporting – including unscheduled events
  • Workflow Data collection direct from the bedside, eSource and from medical devices
  • Timed & untimed (screening) data collection
  • Immediate addition of unscheduled events (AE’s con meds…)
  • Single/multiple subject view – enhances utility for both Phase I & BA/BE Studies
  • Study Subject input screen (diaries/scales/VAS/questionnaires)
  • Multiple Language Interface
  • Graphical display of collected data at bedside

QDAQ Screen (bedside collection)

Data Management

Data Management

Sponsors, monitors and investigators alike can review data in real time, direct from source or bedside in any number of formats and tools. “This allows sponsors immediate access to data for interim analysis during the course of the study, but more importantly, study queries can be initiated and resolved in real time, not weeks or months after the study is complete,” stated Daniel Selness, General Manager and Senior Vice President of Operations for Spaulding Clinical.

NetView™

Manage & Monitor in real time eSource bedside data from your desk

  • MeDRA & WHO Coding of adverse events
  • Investigators, monitors & sponsors view, query & analyse data as it’s being collected
  • Query, Analyze, Clean & Lock Data in real time
  • Remote and real time issue of data queries and resolutions
  • CDISC Compliant

Medidata Rave® Integration

  • Study Set up in ALPHADAS and Meta data passed to Rave
  • Review and manage study data in real time

SAS Integration

  • Clean data from ALPHADAS into SAS

Other Formats

  • SDTM
  • ODM
  • TSV
  • CSV
  • PDF
  • Other formats available

NetView Screen

eCRF

eCRF

  • Browser based data capture
  • Retrospective data entry
  • Partner/remote site data capture

Wardscreen

ePro Patient Diary

ePro Patient Diary

Go beyond the clinical unit and the English language, with the ALPHADAS ePRO, PDAQ (Patient Data AcQuisition)

Highlights

  • Patient data available in real time
  • Patient compliance management
  • 'Mother Tongue' input screen
  • Available across multiple devices - laptop, tablet, smart phone etc.
  • Global applicability beyond English speaking boundaries
  • Reminders and prompts for events
  • All data is available in real time (where connectivity permits).
  • ALPHADAS is also equipped with a language interface which means it can be viewed in any language, whether Latin or character based.
  • Such is the utility and versatility of the ALPHADAS data capture tool QDAQ that as well as eSource bedside data capture it also serves as a patient diary to collect:
    • Questionnaires
    • Scales
    • VAS Scales

PDAQ

PDAQ

Integrate

Integrate™

A clinical research unit has many sophisticated technology solutions that operate independently for specific and discrete challenges, tasks and objectives.

The ALPHADAS Integrate™ software layer enables interfacing between ALPHADAS and other solutions that help drive clarity, accuracy and efficiency for sites and sponsors.

Integrations

  • Late Stage EDC/eCRF
    • Medidata Rave®
      • Both meta data and study data
    • Others being worked on
  • Central Labs
    • Bi-directional Central Labs interfaces
  • Data Management Systems
    • Bi-directional interfaces to streamline and support clinical excellence
  • Medical Devices
    • Vital signs, ECG’s, Glucometers, etc.
  • Communication tools
    • Social media for study subject engagement
      • SMS messaging for recruitment and management, staff alerts

Some of our Integration Partners include:

  • Medidata
  • LabCorp
  • Mortara
  • Exco Intouch
Wardscreen

Wardscreen

“Airport departure Lounge” view of clinical events – when taken, they disappear from view, when late, they change colour, driving protocol compliance proactively.

  • Real time large screen display of clinical schedules colour coded to
    • Late
    • Due
    • Not due
    • Not time critical
  • Adaptable display buy
    • Location
    • User/member of staff
    • Study cohort
    • Study Subject
    • Event type

Wardscreen

Dashboard

Dashboard

  • Real time Clinical & Management Information in visual form
  • Dynamic, user adaptable, immediate feedback
  • Snapshots & export reports to share immediately

Dashboard

Dashboard

Dashboard

ALPHADAS Apps

ALPHADAS Apps

QDAQ

For timed data collection, to not use an app defies logic and common sense. Why?

  • Ensures surety of data collection no matter what
  • Secure & compliant device integrations
  • ‘Smart’ barcodes being able to drive your protocol compliance and workflow efficiencies

PDAQ

Go beyond the clinical unit and the English language, with the ALPHADAS ePRO, PDAQ (Patient Data AcQuisition)

Highlights

  • Patient data available in real time
  • Patient compliance management
  • 'Mother Tongue' input screen
  • Available across multiple devices - laptop, tablet, smart phone etc.
  • Global applicability beyond English speaking boundaries
  • Reminders and prompts for events
  • All data is available in real time (where connectivity permits).
  • ALPHADAS is also equipped with a language interface which means it can be viewed in any language, whether Latin or character based.
  • Such is the utility and versatility of the ALPHADAS data capture tool QDAQ that as well as eSource bedside data capture it also serves as a patient diary to collect:
    • Questionnaires
    • Scales
    • VAS Scales

PDAQ

PDAQ

Wardscreen

“Airport departure Lounge” view of clinical events – when taken, they disappear from view, when late, they change colour, driving protocol compliance proactively.

  • Real time large screen display of clinical schedules colour coded to
    • Late
    • Due
    • Not due
    • Not time critical
  • Adaptable display buy
    • Location
    • User/member of staff
    • Study cohort
    • Study Subject
    • Event type

Wardscreen

Virtual Demonstrations

Request a quote

Virtual Demonstrations

To help you evaluate systems, we believe that an initial, no-pressure demonstration carried out over the Internet is the way to go.

Request a quote

We are excited that you have decided to take the next step with Instem. To provide you with an accurate quotation, we ask that you fill out our form.