clinical development - techsolcorp¤ direct, online entry of data instead of re-typing from...
TRANSCRIPT
Advancing pharma through technology solutions
Clinical DevelopmentBrochure
®TrialOneTMOracle Clinical RDC TMS Platform
TM O racle Siebel CTMSTMOracle Clinical Development analytics
Study Build Assistance Services
Clinical Development Solutions on
Techsol Life Sciences Vertical CloudHyderabad:
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
New Jersey:
Techsol Corporation
101 College Road East Princeton,
NJ 08540
USA +1 415 723 3371
Singapore:
Techsol Group Singapore Pte Ltd
One Raffles Place
Tower One #44-02
Singapore 048616
www.techsolcorp.com www.techsolcorp.comwww.techsolcorp.com
Clinical Development
®TrialOne
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.
®TrialOne , The Operating System for Early Phase Automation
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
TMOracle Clinical RDC TMS Platform
Industry standard EDC and integrated medical coding platform that ensures integrity
of data while improving operational effectiveness
¤ Programmerless edit check interface and global library management
¤ Direct, online entry of data instead of re-typing from handwritten notes or
forms
¤ Paper look and feel for eCRFs
¤ Easy-to-use UI designed with medical users in mind
¤ Audit trail for all changes made entries
¤ Creation and management of standard and custom dictionaries
Our offering includes:
TM 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
¤ Information sharing with sales, marketing, medical affairs
TMOracle 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
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
Clinical Development Solutions 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
Clinical Development
www.techsolcorp.com www.techsolcorp.com