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MCC CRO Performance Metrics Work Groups Kick-Off Session 5.19.2008 [pdf] [Streaming recording link] [Download recording link]
MCC CRO Performance Metrics Survey 4.14.2008 [pdf]
MCC CRO Performance Metrics Steering Committee Seeking Work Group Participants
We would like to extend an invitation to you and your colleagues to participate in the new MCC CRO Performance Metrics initiative. Our goal for this initiative is to:
· Develop metrics to improve clinical trial operations including sponsor, CRO and site processes. Metrics should be developed for the purpose of identifying “what works” and “what needs improvement”.
· Provide the ability to utilize metric data as an information and discussion tool for sponsor and CRO decision makers; drive change as appropriate.
These metrics will provide Sponsors and CROs a baseline set of metrics with a clear explanation of what the metrics mean, how they were derived and how each company can use the metrics to improve efficiency.
The CRO Performance Metrics Steering Committee would like to identify individuals from your company to participate in working groups. Work group participants can expect to spend 3-5 hours per month on work group activities over the next 6-8 months. The table below outlines the areas of interest for each of the five work groups.
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Biometrics WG |
Biostatistics: Defined as process and activities related to the analysis of data. For example, development of the statistical analysis plan, creation of SAS programs, data listings, tables, and figures |
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Data Management: Defined as processes and activities related to the input of data into a database to be used for statistical analysis of the clinical trial, such as data validation plan, query management, edit check specifications, CRF design and production. Can also include EDC, lab data, patient reported outcomes, IVRS data, etc. |
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Business Operations WG |
Business Operations: Defined as process and activities that are required as part of the clinical trial but are not generally governed by SOPs and Regulations. Examples include bidding process, contract process, investigator agreements, etc. |
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Finance: Defined as processes and activities related to project funding, invoicing and payment, spend Vs. budget, etc. |
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Clinical Operations WG |
Clinical Operations: Defined as processes and activities related to the monitoring and site management of the clinical trial including trip reports, patient recruitment, patient enrollment, etc. |
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Medical Writing: Includes but is not limited to protocol drafting, protocol writing, clinical study report, ISS, ISE, manuscripts/publications |
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Project Management: Defined as processes and activities related to the overall management of the clinical trial with particular attention to management of timelines and deliverables. |
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Drug Supply WG |
Drug Supply: Defined as process and activities related to the supply of study product to sites. May include IVRS, packaging, labeling, shipment, import/export licenses, other clinical supplies, insurance. |
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QA, Regulatory & Safety WG |
Quality Assurance: Activities related to the assessment of quality related to the conduct of the clinical trial. Includes but is not limited to supplier audits, clinical site audits, protocol audits, database audits |
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Regulatory Affairs: Activities related to drug release, IRB submissions, MOH submissions IND annual update reports, CTA and IND filings and PSURs. |
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Safety: Defined as processes and activities related to fulfilling IND safety reporting obligations such as IND safety reports, MedWatch/CIOMS reports. Also includes reporting of adverse events, creation of narratives for SAE, etc. |
Special note: Information Technology will be included across the work groups. Information technology may include systems required for conduct of the clinical trial (e.g. Clinical Trial Management Systems, IVRS, EDC systems). Focus is on the system and its performance rather than on the data itself.
Please note that any given individual may participate in one or more work groups. In addition, multiple individuals from the same company may participate in a single work group. Work group participants must be employed by a MCC member organization.
We look forward to working with all of you on this important initiative and hope you will decide to join a MCC CRO Performance Metrics work group. Please complete an online work group registration form [click here to link to form] or contact Linda Sullivan (lsullivan@metricschampion.org) if you are interested in joining a CRO work group.
Thank you,
MCC CRO Steering Committee
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Cory Gutterman (Chair) |
Abbott |
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Ed Cannon |
AstraZeneca |
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Beenu Kapoor |
Covance |
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Holly Hankins |
Eli Lilly |
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Darren Hart
Kathe Balinski |
Genentech
Medarex |
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Magaly Woolard |
Merck |
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April Davis |
Perceptive Informatics |
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Peggy Schrammel |
PharmaNet |
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Lorraine Waring
Monika Frey |
Pfizer
Quintiles |
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Paul Shin |
Valeant |
For additional information, please review the MCC CRO Metrics Initiative Brief. |
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