Metrics-Driven Quality Management

Mamta TrivediGlobal Sr. Director, Quality Assurance

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Current MCC Metrics

Metric Category Metrics Title Definition

1 General Operations

Project Management Turnover

MCC Definition: The percentage of the project management turnover in the central laboratory that have direct communication with sponsor for protocols.

Quintiles Interpretation: Total # key staff who have left team (GPM, PM, DM, GSM) / Total staff on the team.

2 Protocol Initiation

Percentage first supplies shipped on time to the first site for first patient

MCC Definition: The percentage of protocols that have the first supplies to first site shipped date met based on the defined expectations between sponsor and central laboratory.

Not currently reported by Quintiles.

3 Site Initiation Percentage first supplies shipped on time for all sites (all regions)

MCC Definition: The percentage of protocols that have the first supplies shipped date met for all sites (all regions) based on the defined expectations between sponsor and central laboratory.

Quintiles interpretation: Percentage of kits shipped on time to all sites in all regions

4 Data Cleaning Percentage of queries from central laboratory to site based upon requisitions received

MCC Definition: The number of queries generated between the central laboratory and the sites, compared to the number of requisitions received by a central laboratory.

Quintiles Interpretation: Percentage of samples leading to queries from Central Lab to investigator site based upon number of samples in data clarification queue (DCQ).

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MCC (cont’d)

Metric Category Metrics Title Definition

5 Data Cleaning Average turnaround for resolution of queries from central laboratory to site

MCC Definition: Average time required for resolution of queries from central laboratory to site based on the requisitions received by a central laboratory.

Quintiles Interpretation: Total number of DCQs resolved <24 hours / Total number of DCQs. Total number of DCQs resolved 24-48 hours / Total number of DCQs. Total number of DCQs resolved >48 hours / Total number of DCQs.

6 Site Support Services

Percentage of queries from site to central laboratory based upon requisitions received with average turnaround time

MCC Definition: The number of queries generated between the site and the central laboratory, compared to the number of requisitions received for a sponsor and central laboratory, and the average time to resolution.

Quintiles Interpretation: This is called our DCQ Rate which is the total number of samples in DCQ / Total number of samples reported.

7 Site Support Services

Average turnaround time on queries from site to central laboratory

MCC Definition: The average time required to resolve queries generated between the site and the central laboratory for a sponsor and central laboratory.

Quintiles Interpretation: Number of DCQ entries that were resolved during the reporting period.

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MCC (cont’d)

Metric Category Metrics Title Definition

8 Safety Percentage of panics that had both 1st attempt made and were successfully communicated to the sites within the defined turn around times

MCC Definition: Percentage of panics that had both 1st attempt made and were successfully communicated to the sites within the defined turn around times - overall by sponsor and central laboratory.

Quintiles Interpretation: Total alerts responded <24 hours / Total number of alerts.

9 Laboratory Operations

Percentage specific test(s) reported within expected turnaround time

MCC Definition: Percentage of specific test(s) as defined by the sponsor and service provider which reported "results available" or were reported to the investigator sites within the defined turnaround time as agreed upon by the sponsor and service provider -overall by protocol, sponsor and central laboratory.

Quintiles Interpretation: Percentage of tests within stability which are performed and approved within 24 hours of receipt.

10 Laboratory Operations

Percentage tests not reportable

MCC Definition: The percentage of tests not reportable for any reason by "general areas of concerns" overall by sponsor and central laboratory. Not Reportable is defined as tests cancelled for any reason (e.g. QNS, stability, etc).

Quintiles Interpretation: Percentage of tests cancelled due to lab errors.

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MCC (cont’d)

Metric Category Metrics Title Definition

11 Data Management

Percentage on time accepted file transfers

MCC Definition: The percentage of “on time” accepted file transfers as defined by the sponsor and service provider for sponsor and central laboratory.

Quintiles Interpretation: Total number of on-time transfers / Total transfers for that reporting period.

12 Financial Management

Plan, Forecast and Actual Financial Report

MCC Definition: An overview report provided by protocol, which compares the original forecasted budget (Request for Budget Pricing), the updated projected budget (after signature of the Statement of Work) and final 'actual' invoices for the protocol.

Not currently reported by Quintiles.

13 Financial Management

Comparison of budgeted and actual transportation costs by region and/or country

MCC Definition: The transportation costs will be added by region and/or country to each of the segments.

Not currently reported by Quintiles.

14 Quality Assurance

Percentage of audit findings closed within sponsor and central laboratory agreed upon timeframe

MCC Definition: The percentage of the audit findings (including Financial, Quality Assurance and Computer Systems Quality) closed prior to or by the original timeline agreed upon between the sponsor and service provider by sponsor and central laboratory.

Not currently reported by Quintiles.

Future Goals

Create standardized set of Sponsor-specific metrics

Partner to develop risk-based approach Use data to understand Voice of Customer Define Critical to Quality Focus improvements Establish “trust” and “confidence” Position as partner in “resource constraint” age

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Metrics Storyboard

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