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1© 2013 BioClinica, Inc. – Proprietary and Confidential
TOP 10 WAYS to Make
CLINICAL TRIAL MANAGEMENT
Easier and More Effi...
2© 2013 BioClinica, Inc. – Proprietary and Confidential
LIFECYCLE of a
CLINICAL TRIAL
Analysis /
Submission
Study
Assessme...
3© 2013 BioClinica, Inc. – Proprietary and Confidential
SUPPLY PLAN
SHORTAGES
COSTLY OVER-RUNS.
Design your
andto avoid
Su...
4© 2013 BioClinica, Inc. – Proprietary and Confidential
SIMULATE
OPTIMAL SUPPLY CHAIN,
PACKAGING, and CONTINGENCY
PLANS.
S...
5© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Find QUALIFIED
INVESTIGATORS
HIGH QUALI...
6© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
MINEyour investigator database
and REVI...
7© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Make sure SITESreceive the
PROPER TRAIN...
8© 2013 BioClinica, Inc. – Proprietary and Confidential
Site Planning / Initiation
Solution
Simplify
SITE STARTUP
‘SMART’ ...
9© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Take advantage of INDUSTRY
STANDARDS to easily bu...
10© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Solution
Simplify STUDY BUILD by using
CDISC THE...
11© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Specify the STUDY DESIGN
ONCE
Challenge 5
and re...
12© 2013 BioClinica, Inc. – Proprietary and Confidential
Systems Planning
Solution
SIMPLIFYstudy build by RE-USING
STANDAR...
13© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Have all systems INTEGRATE
SAME DATA is never en...
14© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Solution
Integrated data using COMMON IT
METHODO...
15© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Build a RISK-BASED
MONITORING PLAN
based on FDA ...
16© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Flow Design
Determine QUALITY
METRIC TARGETS
and create a
RI...
17© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Collection
Allow sites to enter data easily by providing
TAB...
18© 2013 BioClinica, Inc. – Proprietary and Confidential
Data Collection
Offer sites multiple platforms
to ACCESS STUDY
IN...
19© 2013 BioClinica, Inc. – Proprietary and Confidential
Study Assessment
Go to ONEsource that
PULLS DATA FROM ALL SYSTEMS...
20© 2013 BioClinica, Inc. – Proprietary and Confidential
Study Assessment
Use an INTEGRATED REPORTING
SYSTEM MULTIPLE
SYST...
21© 2013 BioClinica, Inc. – Proprietary and Confidential
Analysis / Submission
Create
NDA SUBMISSION-READY
DOCUMENTS such ...
22© 2013 BioClinica, Inc. – Proprietary and Confidential
Analysis / Submission
Generate electronic CRF
DIRECTLY FROM
YOUR
...
23© 2013 BioClinica, Inc. – Proprietary and Confidential
REVIEW: 10 WAYS to Make CLINICAL
TRIAL MANAGEMENTEasier and More ...
24© 2013 BioClinica, Inc. – Proprietary and Confidential
Want to Learn More?
VIEW THE ON DEMAND
WEBINAR
WATCH WEBINAR NOW>...
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Top 10 Ways to Make Clinical Trial Management Easier and More Efficient

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Want to run faster, more efficient clinical trials? Check out these recommendations from @eClinical_Jen!

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Top 10 Ways to Make Clinical Trial Management Easier and More Efficient

  1. 1. 1© 2013 BioClinica, Inc. – Proprietary and Confidential TOP 10 WAYS to Make CLINICAL TRIAL MANAGEMENT Easier and More Efficient
  2. 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. 3© 2013 BioClinica, Inc. – Proprietary and Confidential SUPPLY PLAN SHORTAGES COSTLY OVER-RUNS. Design your andto avoid Supply Planning Challenge 1
  4. 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. 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. 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. 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. 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. 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. 10© 2013 BioClinica, Inc. – Proprietary and Confidential Systems Planning Solution Simplify STUDY BUILD by using CDISC THERAPEUTIC STANDARD LIBRARIES. and
  11. 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. 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. 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. 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. 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. 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. 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. 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. 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. 20© 2013 BioClinica, Inc. – Proprietary and Confidential Study Assessment Use an INTEGRATED REPORTING SYSTEM MULTIPLE SYSTEMS. Solution that pulls data from
  21. 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. 22© 2013 BioClinica, Inc. – Proprietary and Confidential Analysis / Submission Generate electronic CRF DIRECTLY FROM YOUR EDC SYSTEM. Solution and submission-ready datasets
  23. 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. 24© 2013 BioClinica, Inc. – Proprietary and Confidential Want to Learn More? VIEW THE ON DEMAND WEBINAR WATCH WEBINAR NOW>> Follow Jen Price on Twitter @eClinical_Jen Read the BioClinica Trial Blazers Blog at Bioclinica.com/blog

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