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1. 1© 2013 BioClinica, Inc. – Proprietary and Confidential
TOP 10 WAYS to Make
CLINICAL TRIAL MANAGEMENT
Easier and More Efficient

2. 2© 2013 BioClinica, Inc. – Proprietary and Confidential
LIFECYCLE of a
CLINICAL TRIAL
Analysis /
Submission
Study
Assessment
Data
Collection
Data Flow
Design
Systems
Planning
Site
Planning
/ Initiation
Supply
Planning

3. 3© 2013 BioClinica, Inc. – Proprietary and Confidential
SUPPLY PLAN
SHORTAGES
COSTLY OVER-RUNS.
Design your
andto avoid
Supply Planning
Challenge 1

4. 4© 2013 BioClinica, Inc. – Proprietary and Confidential
SIMULATE
OPTIMAL SUPPLY CHAIN,
PACKAGING, and CONTINGENCY
PLANS.
Supply Planning
Solution
the clinical trial to determine the

5. 5© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Find QUALIFIED
INVESTIGATORS
HIGH QUALITY DATA,
STRONG ENROLLMENT STATISTICS,
LOW PROTOCOL DEVIATIONS.
Challenge 2
with a proven track record for delivering
and

6. 6© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
MINEyour investigator database
and REVIEW past performance,
METRICSto IDENTIFY
QUALIFIED QUALITY SITES.
Solution
therapeutic specialties, protocol deviations, SAE rates,
and other
available

7. 7© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Make sure SITESreceive the
PROPER TRAINING
ADEQUATE FACILITIES
PERSONNEL
Challenge 3
on the protocol and have
to run the study.and

8. 8© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Solution
Simplify
SITE STARTUP
‘SMART’ OFF-LINE
MONITORING
REPORTS.
with easy-to-create and complete

9. 9© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Take advantage of INDUSTRY
STANDARDS to easily build
DATA COLLECTION
SUBMISSION-READYdatasets.
Challenge 4
Case Report Forms (CRFs) and generate

10. 10© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Solution
Simplify STUDY BUILD by using
CDISC THERAPEUTIC
STANDARD
LIBRARIES.
and

11. 11© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Specify the STUDY DESIGN
ONCE
Challenge 5
and re-use it to build
MULTIPLE DATA
COLLECTION SYSTEMS.

12. 12© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Solution
SIMPLIFYstudy build by RE-USING
STANDARD DESIGN
COMPONENTS,
or by sharing design
between data
collection products.

13. 13© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Have all systems INTEGRATE
SAME DATA is never entered into
TWO DIFFERENT SYSTEMS,
AVAILABLE IN MULTIPLE
SYSTEMS if needed.
Challenge 6
but is
so that
the

14. 14© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Solution
Integrated data using COMMON IT
METHODOLOGIES get a
COMPLETE PICTURE
STUDY PROGRESS.
to
of

15. 15© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Build a RISK-BASED
MONITORING PLAN
based on FDA Electronic Source Data
in Clinical Investigations Guidance to
Challenge 7
IMPROVE
Data quality and
ELIMINATE
Unnecessary data
review.

16. 16© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Determine QUALITY
METRIC TARGETS
and create a
RISK-BASED
MONITORING
PLAN.
Solution
Metric MCC TransCelerate
Patient enrollment / retention  
Protocol compliance  
Investigational product supply
management
 
Patient safety  
Site staff issues  
Data quality  

17. 17© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Collection
Allow sites to enter data easily by providing
TABLET-BASED APPSthat use touch
technology for EASY NAVIGATION.
Challenge 8

18. 18© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Collection
Offer sites multiple platforms
to ACCESS STUDY
INFORMATION
MATCHED their
WORKFLOW.
Solution
Clinical EDC – Electronic
Data Capture
Clinical Trial
Image Viewer
Access to your Clinical trial
is now at your fingertips!
BioClinica
Clinical Trial Apps
to

19. 19© 2013 BioClinica, Inc. – Proprietary and Confidential
Study Assessment
Go to ONEsource that
PULLS DATA FROM ALL SYSTEMS,
you to SEEall of your
STUDY METRICS in one place.
Challenge 9
allowing

20. 20© 2013 BioClinica, Inc. – Proprietary and Confidential
Study Assessment
Use an INTEGRATED REPORTING
SYSTEM MULTIPLE
SYSTEMS.
Solution
that pulls data from

21. 21© 2013 BioClinica, Inc. – Proprietary and Confidential
Analysis / Submission
Create
NDA SUBMISSION-READY
DOCUMENTS such as
ELECTRONIC CRFS and DATASETS
right at database lock ─ without needing
special programming expertise.
Challenge 10

22. 22© 2013 BioClinica, Inc. – Proprietary and Confidential
Analysis / Submission
Generate electronic CRF
DIRECTLY FROM
YOUR
EDC
SYSTEM.
Solution
and submission-ready datasets

23. 23© 2013 BioClinica, Inc. – Proprietary and Confidential
REVIEW: 10 WAYS to Make CLINICAL
TRIAL MANAGEMENTEasier and More Efficient
1
Optimize
clinical
supplies
2
Streamline
investigator
selection
with CTMS
3
Simplify site
startup
using offline
monitoring
reports
4
Simplify
EDC study
build using
CDISC &
therapeutic
standard
libraries
5
Simplify IVR
study build
using supply
plan
information
to build IVR
study
6
See
integrated
data & get
the full
picture of
study
progress
7
Determine
quality
metrics &
create a
Risk Based
Monitoring
Plan
8
Track study
status &
quality
metrics
9
Create on-
demand
near SDTM
output for
interim data
review
10
Create
submission-
ready eCRF
in your EDC
Analysis /
Submission
Study
Assessment
Data
Collection
Data Flow
Design
Systems
Planning
Site
Planning
/ Initiation
Supply
Planning

24. 24© 2013 BioClinica, Inc. – Proprietary and Confidential
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