Clinical Data Capture

Clinical Data Capture
CBI Conference; August 20, 2013

Speakers
Ben Yao
Associate
Huron Life Sciences
Manny Tzavlakis
Managing Director
Huron Life Sciences
© 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Joseph Morrell
Manager
Huron Life Sciences

Agenda
• Considerations for Capturing Clinical Data from Third Parties
• Using Technology to Facilitate Data Capture
• New Possibilities
• Q&A

Considerations for Capturing
Clinical Trial Payment Data

Capturing clinical data from third parties: Contract Research Organizations (CROs), Academic
Research Organizations (AROs), Site Management Organizations (SMOs), is a challenge for
many manufacturers. Considerations for successful clinical spend data capture:
Establish
Business
Requirements
• Work with internal compliance/legal to determine baseline requirements for capture of clinical trial
payment data.
• Confer with relevant functional units (e.g. various therapeutic areas, global vs. US, etc.) to determine
data formats across units as well as additional data to be gathered for business purposes.
Finalize
Technical
Requirements
• Determine which systems will be impacted by the clinical trial business requirements.
• Document technical requirements for existing (e.g. Accounts Payable, Customer Master, Reporting
Warehouse) and new (e.g. CRO data capture system) systems.
Develop
Business
Processes
• Identify resources to provide CROs with updated trial information and to manage error resolution.
• Update business processes to ensure that all necessary data are included in site agreements or other
study startup documentation.
• Ensure that resources and processes for reviewing data and managing disputes are in place.
Considerations for Capturing Clinical Trial Data
DEVELOPING REQUIREMENTS AND UPDATING PROCESSES

• When developing requirements for capturing clinical trial payment aggregate
spend data, one of the primary goals should be to enhance data consistency
across all third parties and internal Accounts Payable.
• Consistent identification of investigators, sites, trials, and compound codes
will be essential for efficient generation of aggregate spend reports.

When developing business and technical requirements, a manufacturer should consider
that different business units may:
• Have different formats for data such as site number, protocol/trial number, etc., or may or
may not use some of these data elements consistently
• In limited cases such as certain post-marketing studies, have more than one principal
investigator
• Utilize different types of healthcare professionals (e.g. doctors, PhDs, dieticians, or others)
as investigators
• Issue payments to investigators via investigator sponsored trial payments
When developing processes, consider that:
• Different business units may contract with sites in different ways (e.g. directly or via CROs
or other contracting vendors)
• Processes must be established to account for when a principal investigator at a given
study site changes

Using Technology to Facilitate
Data Capture: One Solution

Using Technology to Facilitate Data Capture
DEVELOPING ONE SOURCE OF CLINICAL TRIAL SITE PAYMENT DATA
In general, clinical trial site payment data will be housed in a variety of systems
across:
Manufacturers should consider deploying one system to consolidate this data to
promote:
• The data consistency described previously.
• The ability to aggregate, review, and analyze data by investigator, site, or compound.
• The ability to monitor the compliance of CROs with the manufacturer’s reporting deadlines.
• A single source of clinical trial payment data for integration into the manufacturer’s existing
aggregate spend reporting architecture.

Principles of the CRO Data Capture System
• Develop standard Excel/flat file templates that are acceptable to all business and geographic
regions; deploy this template to all CROs and mandate compliance with the data requirements.
• Establish a consistent reporting and error resolution schedule across all CROs.
• Validate data against business rules prior to processing into the aggregate spend architecture.
• Provide a single source of clinical trial site payment data for aggregate spend reporting
purposes.
BENEFITS OF CENTRALIZED CLINICAL TRIAL PAYMENT DATA

• If a CRO submits a record that does not
match your master list of:
• Trials
• Compounds
• Investigators
• Sites
That record will be returned to the relevant
CRO for correction. This validation will help
reduce data errors within a manufacturer’s
aggregate spend architecture.
• The CRO Data Capture System will also
monitor to ensure that CROs submit data in
accordance with the manufacturer’s
guidelines. CROs that do not meet timing
guidelines will be alerted by the System.
BENEFITS OF CENTRALIZED CLINICAL TRIAL PAYMENT DATA: VALIDATION

OPTIONAL CUSTOMER STANDARDIZATION AND MATCHING FUNCTIONALITY
• If a CRO submits a record that does not
match your master list of:
• Investigators
• Sites (Organizations)
That record can be automatically
standardized and matched against your
master list and either assigned to an existing
master unique ID or sent for manual
resolution.
• CROs are notified of resolved records to
reduce subsequent errors.
• Records that are of very low quality will be
returned to the CRO for correction and re-
submission.
• Customer matching will reduce the volume of
errors going back to the CROs when a
unique ID has not been provided

Key Challenges & Best Practices
CAPTURING CLINICAL PAYMENTS
Selected Key Challenges
Navigation of the complexity of reporting relationships (e.g. “research” chain scenarios with downstream
payments)
Engagement with third parties who utilize non-traditional research methods (e.g. SMOs and AROs); getting
buyoff and cooperation with frequent and accurate reporting
Integration of third party systems, data structure and processes to align with reporting process
Best Practices
Data capture in upstream business processes to accommodate consistent business rules at a later stage
Creation and utilization of a centralized customer master to track both HCP and HCO spend across the
organization; shared customer IDs with third party partners
Early and frequent onboarding for third party partners to ensure buy-in, organizational support, and
solution identification. Continuous and open communication amongst stakeholders

• Healthcare Practitioners (HCPs) involved in Clinical Trials are
expected to decrease between 25 – 50% due to the Open Payments
Act according to ASCO
• With limited Clinical Key Opinion Leaders (KOLs), manufacturers will
be competing for a smaller number of investigators and specialists
• Utilizing the data store created by capturing Clinical Transparency
information, manufacturers can build new data models to determine
where KOLs can be more effectively utilized within an organization,
particularly in various specialty markets
• Clean data is the key to this – the more accurate the data in a
Clinical reporting data store, the more effective a manufacturer can
be in targeting Clinical KOLs
New Possibilities
AFTERMATH OF A CLINICAL TRANSPARENCY PROGRAM

New Possibilities
16© 2013 Huron Consulting Group. All Rights Reserved. Proprietary & Confidential.
Network analysis
of 1,000 authors
who represent
the main core of
published
research in
specialized CNS
(For illustrative purposes only. Not final product.)

New Possibilities
Heat mapping:
Identify large
concentrations
of HCPs, HCOs
and research
sites along with
reported spend

Clinical Data Capture

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