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1. Full Service
25
CRO
YEARS
Accelerating Pharma time-to-market, cost effectively Track Record
Clinical data management
Asia Europe Americas
Clinical data management capability
1

2. Full Service
25
CRO
Overview of CDM services YEARS
Track Record
• Project management
• Protocol review
• CRF design
• Database design
• CRF tracking
• Data entry
• Data management plan
• Data validation specifications
• Discrepancy management
• Query generation
• Laboratory data management
• SAE reconciliation
• Electronic data transfer
2

3. Full Service
25
CRO
IT Infrastructure YEARS
Track Record
High quality Service High quality Service Compliance to SOP and
Delivery Support Delivery regulation
CDM Central Lab Medical Writing
Services
Pharmacovigilance BA/BE Statistical Analysis
Clinone/
OC OC RDC MedDRA WHO DD DMS SAS STARLIMS
Application ARK
Business Applications are in 3 tier architecture & deployed in test and production environment separately
Cisco Routers/ Scalable & High capacity Qualified &
Windows Oracle / SQL SAN
Infrastructure Switches/ Structured B/W internet & Trained
OS Database Storage
Firewall Network WAN links People
Quality &
Standards ISO 9001, ISO 27001, CSV, 21 CFR PART 11 Compliance, IT Policies & SOPs
3

4. Full Service
25
CRO
CDSM platform deployed by Infosys YEARS
Track Record
• Oracle 4.5.3 with RDC
• TMS 4.6 integrated with WHO-DDE and MedDRA dictionaries
• SAS 9.2
• Deployed in 3 environments, test, development and production with 3 tier architecture
• Database server is on UNIX OS for high availability
• Sized to take high volumes
• Validated as per CSV lifecycle with IQ, OQ and PQ
• System compliant to 21 CFR PART 11 and audited by Lachman Associates
• Annotations are done as per CDISC convention/sponsor specific
• SOPs in line with GCDMP and ICH GCP standards and recommendations
• Stability is time tested with 54 projects handled through current system
Mature CDM system with proven performance
4

5. Full Service
25
CRO
Data Security Policy & Disaster Recovery Plan
21 CFR Part 11 compliant, security controls follow ISO 27001 standards YEARS
Track Record
Data Security Policy Disaster Recovery Plan
• Secure data center with biometric access control & Enterprise wide disaster recovery plan (SOP) to
surveillance camera take care of business continuity in case of natural
• IT policies for password management, shared calamities and disasters
resources, end-point security BCPs to take care of any circumstance of non
• Antivirus, content /URL/spam filtering system, and availability of business critical applications
network monitoring systems
Replication of database archival logs to different
• Perimeter firewall prevents unauthorized access. location for restoring data up to latest transaction
High level encryption compatible
Backup & restore policies with written RPO and
• Data transfer of secure FTP, secure email thru site-
RTO
to-site VPN/Internet
• Role based access for all the applications Mock testing of backup restore procedures on
regular basis
Data Backup
Online backup system with tape library
Daily incremental backup and weekly full backup
Onsite storage of data tapes in fireproof data safe and offsite storage with archival agency
5

6. Full Service
25
CRO
Experience and resources YEARS
Track Record
FUNCTION EXPERIENCE STAFF IN STAFF IN Σ
EUROPE INDIA
Data management Up to 8 years 1 6 7
programmer
Data manager Up to 15 years 3 12 15
Clinical data associate Up to 3 years 5 6 11
Database administrator Up to 8 years 2 1 3
Biostatistician Up to 28 years 2 8 10
Statistical programmer Up to 15 years 4 5 9
Medical writer / coder Up to 20 years 2 13 15
Σ 19 51 70
Deep domain experience both in Europe and India
6

7. Full Service
25
CRO
CDM Team
YEARS
Track Record
Data managers Database administrator
Database
programmers
Clinical data associates
Medical coder
Biostatistician /
SAS programmer
This team is led by highly qualified leaders with deep domain experience
Qualified in medicine, pharmacy, biotech or IT & experience in CDM

8. Full Service
25
CRO
Project management –Communication channel YEARS
Can set up project management between Europe, Asia and USA Track Record
STAT
SITES
CRL
DM Programmer
PDM
PM Data Manager
Clin Data Assoc
Medical Coders
SPONSOR QA
8

9. Full Service
25
CRO
CDM workflow YEARS
Workflow & process built around globally accepted practice Track Record
Study setup CRF annotation
•CDISC compatible
• Resource allocation CRF Designing DB design & validation
•Sponsor specific
• Project plan
• Training
Data management plan Prg of validation checks
DATABASE LIVE
BV
CRF data Data entry Data validation
•Receipt and tracking
•Control and storage
Paper -CRF • Discrepancy management
Non- CRF data
Query generation &
Medical coding
Database lock resolution Quality control
Statistical analysis SAE reconciliation
9

10. Full Service
25
CRO
RDC Project Execution & Delivery Process (1/2)
YEARS
Track Record
EA Project Management Team
Escalation
Sponsor
EDC
Country Project Manager 1
System;
Country Project Manager 2
Other OC RDC
Services
---------
4.5.3
----------
Country Project Manager 9
Database Design
Discrepancy Management
Quality Control, Database
Lock
CDM Team
Countries
RDC Helpdesk
Sites
Patients
10

11. Full Service
25
CRO
RDC Project Execution & Delivery Process (2/2)
YEARS
Track Record
• End-to-end clinical data management activities will be performed by trained and an experienced
team. Each functional representative on a team brings a unique set of experiences, skills, and
knowledge
• Data management activities performed will be compliant to the SOPs. QC process is implemented
to verify that processes and procedures have been followed including documentation
• The data management system used is OC RDC tool which is stable, 21 CFR PART 11 Compliant
and web based application hosted in MAL data center on high capacity servers.
• The study database is validated prior to the start of live data entry.
• A well defined Data Management Plan is prepared which defines the scope of work,
responsibilities, communication plan, description of the various data management activities
performed, timelines, Quality and regulatory standards to be met and how they will be achieved,
Communication plan , Applicable processes and SOPs including project specific processes and
procedures
– Prior to database lock, the QC of all the critical data points is performed and a final inspection is
performed on all the data points of the sample size subjects. The database is audited for accuracy
and completeness
• Regular updates is provided to the sponsors at regular intervals in the form of status reports
• Communication channel between the sponsor and the CRO will be clearly defined at the
beginning of the study
11

12. Full Service
25
CRO
Electronic data capture system build workflow
(including but not limited to) YEARS
Track Record
12

13. Full Service
Data Entry and Discrepancy Management in in RDC 25
CRO
YEARS
Track Record
Data entered by site
staff
System-generated Discrepancy closed
Site staff correct
by system, CRA or
discrepancies eCRF
DM
Changes
rejected
Validation Site staff correct CRA reviews
eCRF or comment changes or CRA performs SDV
Checks on entered data comments
Investigator
approves eCRF CRA verifies eCRF
Casebook
13

14. Full Service
25
CRO
RDC Work Flow Diagram (for a complete study) YEARS
Track Record
FPI LPO
Protocol
Review
CRF DB Design Edit Checks RDC Training for DB Maintenance DB
Review & Validation programming Site Personnel Closure
External Data
Definition
Discrepancy
Management
Site Provisioning
14

15. Full Service
25
CRO
Performance - Quality measures YEARS
Track Record
DB lock checklist Clinical
DB lock study report
100% check
Quality control is applied to each stage of Statistical of numbers,
data handling driven by SOP to ensure that analysis: check of
all data are reliable and have been Double pro- statements
processed and reported correctly. gramming,
Blind
table check
data
QA- CRF to review
Programmed & database
manual checks, inspection
clean and
Double dirty dummies
Finalize DB CRF data entry
structure on tracking
System full dummy
validation extract
by CSV
team
GCDMP, ICH GCP & FDA 21CFR Part 11 followed in the process
15

16. Full Service
25
CRO
CDM experience- India since 2005
Wide therapeutic experience and consistent growth YEARS
Track Record
Oncology, 9, Respiratory, 13,
15% 21%
NSAID, 1, 2%
Neurology, 3, 4%
Musculoskeletal, Nutrition, 1, 2%
3, 5%
Gastroenterolog Ophthalmology,
y, 4, 7% 7, 11%
Endocrinology,
5, 8% N = 61
Dermatology, 3, Cardiology, 12,
5% 20%
Year 2005 2006 2007 2008 2009 2010 2011
No. of Studies 3 13 9 8 16 5 7
No. of CRF pages 107 6589 57642 65214 31230 73003 24346
handled
16

17. Full Service
25
CRO
Flexible service delivery models
YEARS
Track Record
India
EU Experience, India advantage
40
No. of trials
30
PM in PM in PM in
38 Frankfurt Bangalore Frankfurt
20
23 Conduct Conduct in Conduct in
10
in FFM BLR BLR & FFM
0
Standalone End to end
Europe
Deliver
quality data
speedily
at
competitive
cost
&
personalized
service

18. Full Service
25
CRO
Contact us www.ecronacunova.com YEARS
Track Record
We accelerate Pharma time-to-market cost effectively
ASIA EUROPE AMERICAS
SJR I Park, Mobius Hahnstrasse 70 502 Carnegie Center
EPIP, Whitefield D-60528 Suite # 100 Princeton
Bangalore – 560 066 Frankfurt NJ 08540,
India Germany USA
bdasia@ecronacunova.com bdeurope@ecronacunova.com bdamericas@ecronacunova.com
+91 80 6691 5787 +49 69 6680300 +1 973 396 2742
Thank You
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