MODIFICATION
D -- Clinical Trial Support For DCP, National Cancer Institute, Division of Cancer Prevention
- Notice Date
- 12/10/2002
- Notice Type
- Modification
- Contracting Office
- Minerals Management Service GovWorks (Franchise) 381 Elden Street, MS 2500 Herndon VA 20170
- ZIP Code
- 80225-0165
- Solicitation Number
- 14350403RP70142
- Response Due
- 1/10/2003
- Archive Date
- 12/10/2003
- Point of Contact
- Shanda Georg Business Specialist 7037871758 Shanda.Georg@mms.gov;
- E-Mail Address
-
Point of Contact above or IDEASEC HELP DESK
(EC_helpdesk@NBC.GOV)
- Small Business Set-Aside
- N/A
- Description
- Clinical Trial Support for DCP, National Cancer Institute, Division of Cancer Prevention / Dec 10, 2002 Solicitation Due Date: January 10, 2003 4:30pm to shanda.georg@mms.gov. SOW and solicitation instruction letter can be found: www.govworks.gov/vendor/csolicit.asp 1. Question: (Reference 1.0, Background) / Will the Government provide, or otherwise make available, to prospective offerors the DESK and PIMS system documents to review in preparing proposals? Government Response: Information on NCI Clinical Trials infrastructure, including design artifacts is available via the NCICB's WWW site (http://ncicb.nic.nih.gov). No other material is currently available. 2. Question: (Reference 3.0, Objective) / How does, "?the collection and analysis of clinical trial data", differ from NCI's implementation of the Oracle Clinical Trial Product? Government Response: The solicitation does not directly address the collection of primary patient-based clinical trials data, which is the objective of the Oracle Clinical application. 3. Question: (Reference 4.1, Develop a System for Serious Adverse Event Reporting) / Can prospective offerors review the KA feasibility study report? Also, will the Government make available any documents pertaining to CSAERS that prospective offerors can review? Government Response: Documents pertaining to NCI Clinical Trials infrastructure models and design documents are available only through the NCICB's WWW site (http://ncicb.nci.nih.gov). 4. Question: Is CSAERS an in-house NCI developed product or is CSAERS an implementation of Oracle AERS? Government Response: Current plans call for the development of custom software. 5. Question: What is the user base for the SAE, DESK and PIMS systems? Are they all internal NCI / NIH employees or do they include external users? Government Response: The DESK and PIMS systems are designed for internal use. The SAE system will serve both internal and external users. 6. Question: What hardware, operating system and databases (if any) support the PIMS and DESK systems? Government Response: The current technology stack is UNIX based systems, running on SUN platforms. Where databases are utilized, the platform is ORACLE. 7. Question: How many users currently use the systems? Number of active users v/s Number of named users? Government Response: The current number of users is less than 50. The SAE system may support a greater load. 8. Question: What is the Average Network Bandwidth per user? Government Response: Users are assumed to have high-speed internet access. 9. Question: Are there any Interfaces between DESK / PIMS systems and any other systems? Government Response: There are currently no direct connections between DESK PIMS and other systems maintained by the NCICB. a. If so, please give a brief description of the Interfaces Government Response: N/A. b. Interface Type (Input / Output/ Both) Government Response: N/A. c. Interface Method (Real-time, Batch mode) Government Response: N/A. d. Interface Volume / Average Record Size Government Response: N/A. 10. Question: Is there a requirement for an interface between SAE and DESK or PIMS? Government Response: SAE and DESK/PIMS systems will need to interface. 11. Question: What are the requirements for the hardware platforms for SAE? Government Response: The preferred platform is UNIX/SUN. 12. Question: Are there any Reporting requirements from DESK / PIMS systems? Government Response: Ideally the systems should support standard regulatory reporting. 13. Question: Are there any security considerations for DESK / PIMS? E.g. firewall, footprints, audit trails, etc Government Response: Yes. 14. Question: Are there any custom Workflow / Notification requirements to be developed? Government Response: Yes. 15. Question: Section 7.0. Contractor qualification criteria requires in-depth knowledge of NCI Enterprise models and DESK and PIMS. Is there a specific facility that will be used to judge qualifications? Government Response: Knowledge of the NCI Enterprise models will be evaluated based on their described use in response to the solicitation, or indications on why they will not be used. 16. Question: Is there an incumbent contractor? Can you provide information about the number of FTE's currently supporting the systems? Government Response: The incumbent contractor is Oracle Corporation. For numerous reasons, it is not possible to provide an FTE count for these systems. 17. Question: What is the start date for the period of performance? Government Response: At award of contract for a period of six months, with possible options (3 option periods = 6 months each). Question: Are there any requirements for training curriculum development or training delivery for the SAE system under the terms of this contract? If so, what process did DCP use to train users on the DESK and PIMS system? Government Response: Development of training curriculum is not part of the solicitation. 18. Question: The Statement of Work does not include organizational change management tasks or deliverables customarily associated with enterprise systems implementation -- such as organizational impact assessment, workforce transition, communications, training. Are DCP staff resources rather than contractor staff resources being applied to these activities? Government Response: Change Management tasks are covered by other entities. However, the contractor is expected to utilize best practices for development and as such should include effort tracking the development process and ongoing efforts to assess user needs.
- Web Link
-
Please click here to view more details.
(http://www.eps.gov/spg/DOI/MMS/WPB/14350403RP70142/listing.html)
- Place of Performance
- Address: NIH/NCI/OD/NCICB Rockville, Maryland
- Zip Code: 20852
- Country: USA
- Zip Code: 20852
- Record
- SN00221074-F 20021212/021211052934 (fbodaily.com)
- Source
-
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