Early Phase Clinic Automation - TrialOne - PowerPoint PPT Presentation

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Early Phase Clinic Automation - TrialOne

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Our Phase 1 clinic data eSource experts provide various hand holding services to enable full automation and realize the potential of eSource. For more details, please do visit – PowerPoint PPT presentation

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Title: Early Phase Clinic Automation - TrialOne


1
Early Phase Clinic Automation TrialOne
2
Overview
The process of performing a clinical trial has
continued to evolve significantly over the last
decade. Bulk of the clinical trial conduct has
moved from locally developed PC based data
capture to enterprise wide CTMS to trial specific
cloud based applications. Techsol along with its
technology partners offers clinical development
services that would help achieve accuracy while
keeping to the timelines of study conduct. Our
services and partner products offer excellent
security and monitoring capability while lowering
the cost of study conduct. We introduce high
levels of efficiency by simplifying processes,
enhancing quality of data and reducing
coordination effort.
3
Our Offering Includes
  • Proven, browser-based, customizable and scalable
    technology with user friendly
  • interface for early phase clinical studies.
  • Customizable subject recruitment database.
  • Real-time alerts, edit checks.
  • Interface with numerous devices - vital signs,
    ECG, telemetry, scales,
  • balances, scanners, printers, foot pedals.
  • Support CDISC, CDASH and SDTM standards including
    SAS Datasets, PIPE,
  • Tab, CSV, completed CRFs and annotated CRFs.

4
Oracle Clinical RDC TMS Platform
  • Proven, browser-based, customizable and scalable
    technology with user friendly
  • interface for early phase clinical studies.
  • Customizable subject recruitment database
  • Real-time alerts, edit checks
  • Interface with numerous devices - vital signs,
    ECG, telemetry, scales,
  • balances, scanners, printers, foot pedals
  • Support CDISC, CDASH and SDTM standards including
    SAS Datasets, PIPE,
  • Tab, CSV, completed CRFs and annotated CRFs

5
Oracle Siebel CTMS
  • A centralized trial management system that allows
    you to manage complexity and achieve compliance
    consistently.
  • Centralized trial management database provides
    users with the most relevant
  • information based on their specific roles and
    responsibilities
  • Enabling efficient planning and tracking of
    clinical studies
  • Improving relationships with investigators, CROs,
    and regulators
  • Providing real-time trial status
  • Improving productivity and effectiveness

6
Clinical Development Analytics
  • Garner critical data insights that would help you
    to run clinical programs more
  • efficiently by delivering timely access to
    information and increased productivity.
  • Rapid visibility into clinical data from multiple
    source systems.
  • Sponsors and CROs to holistically manage all
    studies.
  • Rich set of pre-built reports and role-based
    dashboards.
  • Detailed performance management metrics for
    improving processes.
  • Milestone tracking and provides project schedule
    risk alerts.

7
Study Build Assistance Services
  • Study build service on InForm Central Designer
    and Oracle Clinical.
  • eCRF design and implementation.
  • Database design (variable formats, codelists,
    logical flow, etc.).
  • Database User Acceptance Testing and
    implementation.
  • Data Management Plan creation (which includes
    references to all planning and
  • database documents).
  • Knowledge and use of current data standards
    (SDTM, CDASH, and other CDISC
  • Models.

8
CDS on Techsol Life Sciences Vertical Cloud
  • Choose your deployment options and services on
    the CDM/EDC, CTMS, Early Phase Clinic Automation
    and Analytics /BI platforms.
  • Offered as an integrated and individual
    applications in a Software as a Service
  • (SaaS) model on Techsol Life Sciences Vertical
    Cloud.
  • Validation/Implementation, case data migration,
    systems migration, ETL services
  • and end user training services.
  • Study build and design services on Central
    Designer and Oracle Clinical.
  • Certified implementation specialist.

9
Contact Us
Singapore Techsol Group Singapore Pte Ltd One
Raffles Place Tower One 44-02 Singapore 048616
New Jersey Techsol Corporation 101 College Road
East Princeton, NJ 08540 USA 1 415 723 3371
Hyderabad Techsol Systems India Private
Limited Suite 2-93/8 2-93/9, Level-3, Three
Cube Towers, White Fields, Kondapur, Hyderabad
500084, India Board 91 40 4900 8888 APAC 91
888 603 5847
To know more about Advancing pharma through
technology solutions, please do visit at
https//techsolcorp.com/
10
Thank You
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