Kreara - Clinical Data management and Biomterics

Friday, May 02, 2008 Business Proposition

Clinical Data Management and Biometric Services


In a snapshot

Project ManagementStatistical Services

Clinical Data Management

Medical Writing

Medical Coding

Training


Project Initiation


Project Plan

Director negotiates the

contract

Project Manager appointed

Assigns System Admin and QA for the project

Delivery of various initiation documents

Project Kick off meeting

Work Breakdown Structure

Active directories and Change Control

Project Initiation Workflow

Initiate the project

Statement of Requirements

Project Initiation Document

Master List of Deliverables

Work Breakdown Structure

Project Schedule

Project Plan

Quality Plan


Periodic Review and Status Reporting

Review outstanding issues on the issue tracker

Review QA non conformances

Review and document show stoppers

Identify potential issues and roadblocks

Plan the work breakdown for the next session

Setup of Status reports


Security


Security Levels

ORGANIZATION

PROJECT

Access to CVS

Access to Project related directory

Cabinet file security

Remote site security

Server security

System security

Various levels of personal security

Access to CVS


Access to CVS


Access to CVS


FTP, Email, VPN security

Database security

Document filing in the cabinet

Access to CVS



Disaster Management and Recovery


Disaster Management

SAS Programs

Documents

Versions

Data Entry application code

Scanned CRFS

All Data management documents

CVS Repository

DATA Database

Daily back ups of CVS and databaseto a back up server

Daily back ups of CVS and database

to a Remote back up server

Weekly media backup on a DVD

which will be transferred to a bank locker

Automated Automated Manual


Clinical Data Management


Data Management Plan

CRF Design CRF Manual Data Definition Table Data Validation Document

Annotated CRF

Database Design

EZCRF modification

PART 11 Compliance Document

Data Entry - Primary

Data Entry - Secondary

Query, DCF and Resolution

Compare Primary and Secondary Database

Resolve Conflicts and Queries

Critical Values Manual Check

Data Management Workflow


Strategy for CDISC migration

Legacy Documents Received

Decision regarding data analysis

Map blank CRF to SDTM

Create SDTM data metadata

Create zero observation SDTM datasets

Statistical Analysis Plan

Create Analysis data metadata

Create zero observation Analysis datasets

Receive Legacy Data

Create SDTM datasets

Create Analysis datasets

Derived data to SDTM

Finalize SDTM datasets

Adverse Event and Concomitant medication

coding

Generate analyses

Write Study Report

Create Analysis resulkts metadata

Reviewers guide Covering Letter Create Define Create XPT


Biostatistical Services


Statistical Analysis workflow

Sample Size Justification

List of Tables, Listings and Graphs

Tables/Listing Templates

Program Tables & Listings

SAS Code validation and comments

Populate Tables and Listings

Review Output

Revise Code as per the review comments

Repeat with more data

Statistical Analysis Plan

Code Validation and revision


Medical Writing


Medical writing workflow

ICH E3 TemplateFinal version of

the study protocol

Preliminary draft Created

Draft Review and Approval

Data from Tables and Listing

Statistical Report

Full CSR Draft

Load Locked Data from Tables and Listings

FINAL DRAFT

CLINICAL STUDY REPORT


Location


Kerala

Lower Salaries

Great Talent Pool – You will find massive numbers of state graduates in any of the major consulting organizations in India

Lower attrition rate

Woman empowered state

Industry friendly government

Pollution free and Green state

Less traffic compared to many metros

Low infrastructure cost

3 International airports


We have worked with



THANK YOU FOR THE SUPPORT

Kreara - Clinical Data management and Biomterics

Technology

project related

clinical data

databaseto

cvsaccess

cvs