Wincere CRO Services, Clinical Solution Consulting

1. Study Database
Development
Bring Your Innovative Ideas to Life
Clinical Data
Management
Quality Assurance
& Compliance
Regulatory Affairs
Post Approval
Statistical
Programming
Clinical
Programming &
Reporting
Pharmacovigilance

2. Mobilize resources to cater your on-site needs
Economize the cost of your trials by offering remote resources
SANTA CLARA
MINNEAPOLIS
ARMENIA
NOIDA
HYDERABAD &
BANGALORE
Proven, Visionary, Resourceful – Global Consultative CRO

3.  Certified database development team
 Support individual study or clinical program needs
Study Database
Development
 Use our proprietary study design platform
 Build a robust, cost-effective, secure, and compliant study
 Flexible to meet your study requirements

4. Critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data
from clinical trials.
Clinical Data Management

5. Clinical Programming & Reporting
Offer superior tools, metrics,
datasets, and data platforms
for detailed, timely reporting
Experienced in
range of interfaces
including BASE
SAS®, SAS/STAT®,
and SAS/ACCESS®

6. Our programming code is in compliance
Our Statistical Programming team follows best practices
and is equipped with cutting-edge technology to offer
flexibility, scalability, adaptability, reusability, and optimal
readability.

7. Pharmacovigilance … Identify the hazards
associated with pharmaceutical products and
minimize the risk of any harm that may come to
patients.
Adherence to the reporting requirements of the FDA, EMEA, MHRA,
and other regulatory authorities

8. Quality Assurance + Compliance
Our experienced QA audit team is well-versed in local, national, and
international regulations, and includes multilingual staff, licensed
physicians, legal experts, and former FDA personnel.
Our professionals use a risk-based approach

9. Our experts ensure your drug or device follows all mandatory U.S. FDA
and international regulations and meets all applicable requirements.
Our team reviews and prepares documents for IND, ANDA, IMPD, and CTA submissions

10. Our post-approval services include
a seamless blend of risk
management plans and research to
support risk evaluation and
mitigation strategies (REMS),
comparative effectiveness,
registries, phase IV studies, and
epidemiology
Ensures adherence to safety plans
required by the FDA, ICH, and
EMEA to retain your approved
status

11. A Big Data based Clinical Analytics Platform

12. ANALYSIS
Data is analyzed and
presented in visually rich
format
DISCOVERY
Perform data mining and
analysis
HARMONIZATION
Data is normalized in the
Hadoop setup
INGESTION
Data collection from
desperate sources
Mine and analyse unstructured data, achieve significant business value
Advanced analytics reduces clinical
costs, enables accurate decision making
TRANSFORMATION
Data enrichment and
storage

13. Low Cost Large
Data Storage
Data Generated At
An Exponential
Pace
Integration Of Disparate
Data Sources
Faster Process &
Real-time Insights
Quick
Action
Enhanced Business
Value
Predictive Analysis &
Decision Making
Quick Trend
Analysis
Risk Identification
& Actions
Reducing & Monitoring
Trials Cost / Values
100% SDV
NEED FOR
ANALYTICS
NEED FOR BIG
DATA
RISK BASED
MONITORNING
Adoption of Big Data based Analytics Solution

14. Data
Modelling
Active Archive Big Data
Repository
Real Time Stream
Processing
Message Queue
Real Time Processing
Batch Time Processing
Highly Scalable Architecture
EDC
CTMS
IVRS
Images
Labs
Investigator Data
Data Ingestion
MCC REPORTS
ADVANCED
ANALYTICS
RISK BASED
MONITORING

15. Highly functional
visualizations with
drill downs
On the go reports
delivered via web &
mobile applications
Pixel-perfect
exporting to PDF,
Excel and more
Predictive modeling
and advanced
analytics
End-user
customizable
reporting
Custom Scripting for
automation and complex
computations
Power of Analytics

16. Risk Based Monitoring Module
REDUCE COSTS
• Optimize CRA deployment
• Replace on-site with
centralized monitoring
• Reduce frequency of site visits
SAVE TIME
• Reduce overall SDV time
• Proactively mitigate risks
• Rapid identification of site
bottlenecks for prompt issue
resolution
ENHANCE QUALITY
• More focus on sites with
higher risk
• Improved data quality as
compared to SDV
Email Alerts
Report Indicators
Customized Alerts
App Notifications
KPIs
Site 01
Site 02
Site 03
Site 04
STUDY
Risk Scoring
Algorithms
Data Mining
Event Handlers
CDL RBM ENGINE
Tailored risk based Monitoring plan
ONSITE MONITORING AS NEEDED

17. Continuous
review and
analysis of risk
indicators and
performance
metrics
Generate
proactive
notifications
and alerts
Identify
trends,
outliers and
underlying
patterns
Define risk
indicators
with focused
monitoring
and QM
Enhanced
security and
customized
user access
and
authenticatio
n
Predictive
analytics to
guide risk
management
approach
Visually rich
end-user
reports with
key
performance
indicators
Measure
absolute and
relative trial
performance
Features of Risk Based Monitoring Module

18. Allows
monitoring at
site-study-
protocol levels
Use statistics to
find hidden data
trends
Increase patient
safety and site
efficiency
Reduces the time
and manual
effort involved in
managing risks
Enables proactive
risk based
monitoring
Drives global
consistency in
processes
Benefits of Risk Based Monitoring

19. MEDICAL & SCIENTIFIC WRITING

20. Medical Writing, Publishing and Publications
Regulatory MW (15), Narratives (7),
Drug Safety & Risk Management (8),
Publications & Med-Comm (25), Clinical Trial Disclosure (4),
QC panel (8) & Document Publishing (3)
63
36
218
83
353
224
121
72
109
23
240
95 84
21 20
57
0
50
100
150
200
250
300
350
400
MODULES
2,4 & 5 FOR 4 ECTDS
WRITING & COMPILATION
18500+ NARRATIVES
5500+ STANDALONEQC OF
NARRATIVES
Document publishing and pre-publishing
Standalone QC

21. 2,803
1,901
4
40
336
380
3,950
4,019
3,186
Narratives Writing
Endocrinology Immunology & Infections Bone and Joint disorders
Oncology Neuroscience Cardiovascular & Metabolism
Genitourinary Gastroenterology Others
Total Volume = 16,619
2%
16%
18%
21%
43%
Immunology
Infections
Anti-Infectives
Oncology
Neuroscience
Standalone QC of Narratives
Total Volume = 1,127
Medical Writing, Publishing and Publications

22. 2 2 2
4
1
3
1 1 1
2
1
3 3
1
3
1
3 3
1
Oncology Musculoskeletal Neuroscience Cardiovascular &
Metabolism
Other
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
PSUR & RMP: Writing & Standalone QC
PSUR QC RMP QC PSUR Writing RMP Writing
5
2 1
3
1
7
3
1
2
2
6
11
14
2
13
2
4
0
5
10
15
20
25
ASR & DSUR: Writing
DSUR writing ASR writing
Medical Writing, Publishing and Publications
Total Volume: ASR = 23, DSUR = 56
Total Volume: Writing (RMPs = 11, PSUR = 10), QC =
Standalone QC (RMPs = 7, PSURs = 11)

23. Medical Communications
Advertising for Below
the line (BTL) and Above
the line (ATL) campaigns
Communication
development
Clinical
Communications
Data visualization of
scientific information
Disease awareness
campaigns
Scientific promotion
material
Detailing aid, Product brochures,
LBLs, direct mailers, Product
monographs, Disease
information booklets, Web
design, Whitepapers, Webinars

24. Assessment
of causality
Case
processing
Drug Safety and Pharmacovigilance
80 - DSUR
SAFETYEXPERIENCE
200 - CIOMS
550 – SAE Narratives
550 – Case Assessments
1,200 – SAE from Review
20,000 Safety Submissions
Narrative
writing
Assessment of
expectedness
Medical
review of cases
Validation &
Implementation
Of AERS safety
database
Handling
global
PV projects
Handling of
Blinded
Information
Multi-country
Regulatory
Submission
Submission to
EMA Via
EV web tool

25. We Bring Your Innovative Ideas to life.
wincere.com
+1.855.855.2496
sales@wincere.com