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| RFP: 39 - Phase II comparison of Taxol to
investigative anti-angiogenic compound for treatment of
glioblastoma |
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1. Project
Information |
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Organization Type: |
Biotech |
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Headquarters: |
US Domestic |
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Required Work Location: |
Northeast |
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Indication: |
Oncology |
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Work In Progress: |
Phase I |
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Service Category: |
Phase II |
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Study Design: |
Double Blind, Randomized, Cross-over With Comparative
Drug - TAXOL Number of Subjects Evaluable - 60 Required
Statistical Power - >05 Hypothesis to be Tested -
Equivalence to standard treatment Investigators
Identified
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Date Posted: |
1/26/2004 2:09:00 PM |
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Bid Deadline: |
2/26/2004 |
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Question Deadline: |
2/26/2004 |
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Budget (US Dollars): |
Low:
575,000.00 High:
1,500,000.00 |
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Other Budget Information: |
other budget information |
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I/We have facilities in the required work
location. |
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Provide information on how you will perform
this project, and any exceptions: |
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2. Services
Requested |
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Planning Phase |
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Investigator
Brochure |
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IRB/Ethics Committee Submission |
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Expert Panel |
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Product Development Plan |
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CRF Development |
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Provide Clinical Monitor |
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Regulatory Meetings with Authorities |
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Regulatory Plan |
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Other Requirements: |
Clinical Monitor with > 5yrs exp or +2 studies |
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Start Date: |
3/10/2004 |
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End Date: |
7/15/2004 |
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I/We can meet date requirements of this
phase. |
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I/We can perform all required tasks in
this phase. |
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Describe how you will meet requirements of
this phase: |
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Describe past projects you have performed
that required the same tasks/skills as this phase: |
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Phase Bid Price (US Dollars): |
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Execution Phase |
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Adverse Event Processing |
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Adverse Event Reporting |
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CRF Query Resolution |
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Data Validation |
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Data Management |
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Investigator Meeting |
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Investigator and Site Training |
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Safety Data Monitoring Board |
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Site Initiation |
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Other Requirements: |
Existing relationships with packaging vendors |
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Start Date: |
10/30/2004 |
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End Date: |
3/12/2005 |
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I/We can meet date requirements of this
phase. |
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I/We can perform all required tasks in
this phase. |
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Describe how you will meet requirements of
this phase: |
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Describe past projects you have performed
that required the same tasks/skills as this phase: |
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Phase Bid Price (US Dollars): |
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Evaluation Phase |
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Clinical Report |
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Statistical Report |
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Start Date: |
4/11/2006 |
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End Date: |
7/30/2006 |
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I/We can meet date requirements of this phase. |
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I/We can perform all required tasks in this
phase. |
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Describe how you will meet requirements of
this phase: |
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Describe past projects you have performed
that required the same tasks/skills as this phase: |
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Phase Bid Price (US Dollars): |
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Regulatory Submission Phase |
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IND |
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Start Date: |
10/1/2004 |
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End Date: |
5/1/2006 |
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I/We can meet date requirements of this phase. |
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I/We can perform all required tasks in this
phase. |
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Describe how you will meet requirements of
this phase: |
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Describe past projects you have performed
that required the same tasks/skills as this phase: |
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Phase Bid Price (US Dollars): |
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| Do you agree with our Terms of
Use? (yes/no) |
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