Global clinical trial solutions. Real-world results.

© 2013 BioClinica, Inc. – Proprietary and Confidential

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

Jennifer PriceDirector, Clinical Solutions, BioClinica

To watch this content presented in an on demand webinar, visitwww.bioclinica.com/news-events/webinars/top-10-ways-make-clinical-trial-management-easier-and-more-efficient

2© 2013 BioClinica, Inc. – Proprietary and Confidential

Lifecycle of a Clinical Trial

Supply Planning

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Challenge 1Design your supply plan to avoid shortages and costly over-runs.

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SolutionSimulate the clinical trial to determine the optimal supply chain, packaging, and contingency plans.

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Challenge 2Find qualified investigators with a proven track record for delivering high quality data, strong enrollment statistics, and low protocol deviations.

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SolutionMine your investigator database and review past performance, therapeutic specialties, protocol deviations, SAE rates, and other available metrics to identify qualified quality sites.

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Challenge 3Make sure sites receive the proper training on the protocol and have adequate facilities and personnel to run the study.

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SolutionSimplify site startup with easy-to-create and complete ‘Smart’ Off-line Monitoring Reports.

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Challenge 4Take advantage of industry standards to easily build data collection Case Report Forms (CRFs) and generate submission-ready datasets.

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SolutionSimplify study build by using CDISC and therapeutic standard libraries.

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Challenge 5Specify the study design once and re-use it to build multiple data collection systems.

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Forms Library (near SDTM)

13© 2013 BioClinica, Inc. – Proprietary and Confidential

• ReFraction and Visual Acuity CRFBioClinica developed standardized CRFs that contain mostly standardized data collection fields, plus some customized fields for each study. Standard pull-down boxes eliminate the problem of having varying results between studies. This form is available in multiple units depending on what country a study is being conducted.

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1. Clinician can direct subject to begin reading from any row.

2. Scores are automatically calculated for each row.

3. As subject reads letters, clinician enters results (letters read, or ‘no letters missed’).

4. To be valid, the first line recorded must have ‘no letters missed’ (system verifies).

5. Subject reads lines on the chart until 3 or more letters are missed on a line. (system verifies).

6. System derives score.

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SolutionSimplify study build by re-using standard design components, or by sharing design between data collection products.

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Challenge 6Have all systems integrate so that the same data is never entered into two different systems, but is available in multiple systems if needed.

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SolutionIntegrated data using common IT methodologies to get a complete picture of study progress.

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Challenge 7Build a Risk-Based Monitoring Plan based on FDA Electronic Source Data in Clinical Investigations Guidance to improve data quality and eliminate unnecessary data review.

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SolutionDetermine quality metric targets and create a Risk-Based Monitoring Plan.

Metric MCC TransCeleratePatient enrollment / retention Protocol compliance Investigational product supply management

Patient safety Site staff issues Data quality

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Challenge 8Allow sites to enter data easily by providing tablet-based apps that use touch technology for easy navigation.

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SolutionOffer sites multiple platforms to access study information matched to their workflow.

Access to your Clinical trial is now at your fingertips!

Clinical Apps on Windows 8

Clinical EDC – Electronic Data

Capture

Clinical Trial Image Viewer

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Challenge 9Go to one source that pulls data from all systems, allowing you to see all of your study metrics in one place.

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SolutionUse an integrated reporting system that pulls data from multiple systems.

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Challenge 10Create NDA submission-ready documents such as electronic CRFs and datasets right at database lock ─ without needing special programming expertise.

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SolutionGenerate electronic CRF and submission-ready datasets directly from your EDC system.

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Review: 10 Ways to Make Clinical Trial Management Easier and More Efficient

Supply Planning

1Optimize clinical supplies

2Streamline investigator selection with CTMS

3Simplify site startup using offline monitoring reports

4Simplify EDC study build using CDISC & therapeutic standard libraries5Simplify IVR study build using supply plan information to build IVR study

6See integrated data & get the full picture of study progress

7Determine quality metrics & create a Risk Based Monitoring Plan

8Track study status & quality metrics

9Create on-demand near SDTM output for interim data review

10Create submission-ready eCRF in your EDC

28© 2013 BioClinica, Inc. – Proprietary and Confidential

Learn more about BioClinica’s Clinical Trial Management Solutions at www.BioClinica.com

• Follow Jen Price on Twitter @eClinical_Jen• Read the BioClinica Trial Blazers Blog at

Bioclinica.com/blog

To watch this content presented in an on demand webinar, visitwww.bioclinica.com/news-events/webinars/top-10-ways-make-clinical-trial-management-easier-and-more-efficient