ALPHADAS = Day 1 Results

We believe results are what matter and what makes ALPHADAS and the Instem Clinical team unique. We care about the commitment and investment our clients make in choosing ALPHADAS as their system of choice to streamline their clinical operations and we want them to see a Day 1 Return on Investment.  Our early phase expertise is second to none and with more than 100 years of hands-on, practical experience in the Clinical team our clients can be assured that the transformation of how they conduct early phase clinical trials will be handled smoothly and efficiently.

ALPHADAS is a compelling end to end software solution that expedites key drug development decision making and provides operational savings throughout the business. Key benefits include:

  • Optimised volunteer/patient identification & recruitment
  • Reduced study set up times with flexibility for adaptive study design
  • Higher quality data at point of capture
  • Comprehensive eCRF/EDC supports multisite data collection & collaboration
  • Immediate and accessible data review and exporting
  • Direct export of SDTM compliant data
  • Full chain of custody from sample collection through to dispatch
  • Rapid database lock
  • Full offline redundancy
  • 21 CFR Part 11 Compliant

Most importantly ALPHADAS provides results on Day 1 of Go Live!

“Reputation is everything and is one of the primary reasons why we chose ALPHADAS backed by Instem. It’s been an enriching journey and we are excited to realize the benefits of the ALPHADAS system from an onsite operational perspective and to see the advantages and satisfaction it brings to our Sponsors with immediate effect. We’re glad to be working with such a flexible and responsive team at Instem” David Bell, Medical Director and Managing Partner at BioKinetic Europe

The ALPHADAS Suite

ALPHADAS CTMS

Streamline clinical trial processes from trial start to completion and improve site workflow and efficiencies with tools such as include Volunteer Recruitment and Laboratory Management

ALPHADAS CAPTURE

Capture data direct from source instrumentation at bedside so errors are immediately addressed eliminating data queries and enhancing compliance management. Other tools available are our eCRF web based interface and ePRO tablet based patient diary for collection of data by volunteers/patients either onsite or remotely

ALPHADAS REVIEW

Remote real time data monitoring and review, provision of complete management data via the ALPHADAS Dashboard™ and complete audit trail.

ALPHADAS SUBMIT

Regulatory compliant ALPHADAS enables submission of clinical data in a fully SDTM compliant dataset

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.

ALPHADAS

ALPHADAS Academy - Coming Soon

ALPHADAS AcademyThe ALPHADAS Academy is a sophisticated, easy to use, intuitive web based elearning solution that is available on-demand through the Instem University platform whenever our clients need it. It enhances the service offering we provide and is a value-added extension to our software with the objective of making it easier for clients to use ALPHADAS so that users can better perform their jobs. 

The ALPHADAS Academy meets the needs of all users, from super users through to those staff who may only use ALPHADAS infrequently offering clients even more ways to become proficient on ALPHADAS facilitating increased efficiency and effectiveness and fostering a culture of continuous learning.

ALPHADAS - how it works

Fact Sheet

ALPHADAS - how it works

Fact Sheet

ALPHADAS Modules

ALPHADAS CTMS

ALPHADAS CTMS

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

Streamline your clinical trial processes from trial start to completion with our clinically driven site automation tools modules that include Volunteer Recruitment and Laboratory Management.

Volunteer Recruitment & Management  

Key features include:

  • Instantaneously identify and select healthy volunteer/patient populations using an exhaustive, fully searchable demographics and medical history database.
  • Intuitive screening/study visit appointment management
  • Integrated subject payment management

Laboratory Management

Key features include:

  • Intuitive sample handling workflows drive the laboratory processes providing for full chain of custody from blood draw through shipment
  • Batch-based workflows enable efficient processing of sample groups
  • Integrated label generation and barcode confirmation ensures sample integrity

CTMS

Subject Payments

ALPHADAS CAPTURE

ALPHADAS CAPTURE

eSource

Capture data direct from source instrumentation at bedside so errors immediately addressed eliminating data queries and enhancing compliance management

  • Real-time Bedside Direct Data Capture (eSource)
  • Direct capture from medical devices (e.g., ECG, vital signs, etc.)
  • Robust, seamless online/offline data collection
  • Protocol-driven, event-based workflows
  • Barcode confirmation ensures correct subject, sample, time point, etc.
  • Real-time quality checks (e.g., out-of-range, out-of-time window, etc.)
  • Ability to directly review/trend data within the same module

QDAQ Screen (bedside collection)

eCRF

  • Provides a web-based interface for data collection accommodating data transcription from external sources and remote site access (e.g., physician offices, investigator sites, etc.)

Wardscreen

ePRO Patient Diary

  • Tablet-based patient diary tool for collection of data by volunteers/patients either onsite or remotely. Go beyond the clinical unit and the English language and enhance patient compliance and review patient data in real time.

PDAQ

ALPHADAS REVIEW

ALPHADAS REVIEW

Data Review & Management

Remote real time data monitoring and review, provision of complete management data via the ALPHADAS Dashboard™ and complete audit trail.

  • Real-time, web-based data review facilitates timely monitoring of collected data from any location
  • Integrated data cleaning and tracking lead to expedited database lock
  • Email/SMS alerts inform users of status of data/query issuance
  • Ability to import safety laboratory data and integrate into the ALPHADAS® workflow

NetView Screen

ALPHADAS SUBMIT

ALPHADAS SUBMIT

Data Reporting & Export

Regulatory compliant ALPHADAS enables submission of clinical data in a fully SDTM compliant dataset

  • Integrated dashboards provide live feedback/management metrics of all data contained within the system
  • Comprehensive, integrated reporting including standard and customized reports
  • Robust exporting capabilities allowing users to map collected data to a CDISC SDTM standard compliant structure and to a number of common formats (e.g., CSV, TSV, XPT, etc.)

 

Virtual Demonstrations

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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.

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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.