DFS

What we do

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Training
Flexible Project
Management
Standalone
Services
Reporting
Database
Set-up
Data
processing/
delivery
EDC

We provide flexible data solutions
across different therapeutic areas:

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SOP
preparation
PI – PIV
Registry
trials
Rescue
projects

We use

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CRF design
printing &
distribution
Study programs
Client access
to scanned
electronic CRFs
& quiries
Data base
set up
IWRS
EDC
Quality review
4-5-bl
Internet-based
data collection
and project
management
Edit check
specifications
Batch edit
checks
Online clinical
data
management
CRF design
E-diaries
Programming
and data entry
validation
(Data Listings)
Laboratory
data import
Expertise with
coding on
sponsor specific
tools
Adverse events
coding
Medical coding
(MedDRA
coding)
Medical history
coding (WHO
Drug Coding)
Data
import/export

DATA
PROCESSING

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Clinical design
writing
Statistical
Analysis Plans
Calculate
sample
size
Tables design
Quality control
Data
visualization
programming
Clinical
outcome
assessments
Generate
randomization
codes
Statistical
Analysis
System
(SAS)
Statistical
Consulting
Data
Standardization
(CDISC) and
Integration
Adaptive
and Bayesian
Designs
DSMBs
and
Risk-Benefit
Analysis

BIOSTATISTICS

DFS expert has 12 years’ experience and 40% employees have a Ph.D. employees.

All of our statisticians and statistical programmers receive ongoing, intensive training that
incorporates industry information such as:

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21 CFR Part
11
GCP and ICH
standards
such as ICH
E9
Statistical
Principles for
Clinical Trials
SAS software
programming
skills
Statistical
methodology

DFS ongoing services

7-bl2
CRF Template
Development,
Review and
Approval
Data
Management
Plan, Review
and Approval
Annotated CRF
Development,
Review and
Approval
Edit Checks Matrix
(ECM)
Programming Build
and Validation
Database Design
& Build (ODM-file
Development)
Database &
Application Setup
Data Transfer Plan
Development and
Validation, Review
and Approval
Study-Specific
Software
Validation
Software
Testing
Data Validation
Plan
Users Manuals
Customization
CRF
Completion
Guidelines &Training
Practices
Development, Review
& Approval
Data
Management
Trainings
Setup and
Maintenance of
Lab Data
Normal Ranges
Reports
Customization
Listings
Customization
Query
Generation,
Tracking and
Resolution
Data Coding
System
Support
Database
Administration
and Backup
SAE
Reconciliation
Data Transfers
to Project Team
and
Biostatistician
Database
Soft Lock
Final (Hard)
Database
Lock
Final Data
Transfer to
Biostatistician
Preparation of
Final Data
Management
Report
Provision of
documents
required for
DM file
Database
Archiving