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