Attachment8STOATPI.pdf

Attachment 8: Additional Technical Proposal Instructions Page 1 of 3 Including instruction for Sample Task Order RFP Number: N02CN35003-43

Cancer Prevention Clinical Trials Auditing and Informatics Support

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

SAMPLE TASK ORDER

The following additional Technical Proposal instructions reflect the requirements of the RFP and are meant to provide additional instructions as well as a uniform format for technical proposals.

The information requested in these instructions should be used as a guide for formatting and preparing the proposal. Offerors should follow the instructions in Section L of the solicitation, as well as include the information requested in this Attachment.

Offerors are advised to give careful consideration to the Task Order Statement of Work (SOW), all reference material, and attachments, the technical evaluation criteria, and, the RFP as a whole, in the development of their Technical Proposal.

Offerors who propose subcontracts to perform portions of the SOW should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration between the prime and subcontractor(s), and the expected advantages of such an approach.

A. TECHNICAL APPROACH

Offerors shall submit a Technical Proposal that addresses all areas in the SOW. If the proposed approach will involve a subcontracting arrangement, the Offeror should include a letter(s) of commitment from the subcontractor(s), documentation of the subcontractor’s expertise, qualifications and prior performance, and a narrative describing how the contractor will manage the subcontractor(s).

Offerors should provide a draft transition plan demonstrating the feasibility of their proposed approach for a seamless transition of all systems, materials, services and tasks in the SOW from the incumbent contractor.

Offerors should provide an overall task order project plan, with specific project plans for each task area, that include the key project activities and methodology, timelines, resources and overall and task-specific budgets.

The Technical Proposal should reflect a clear understanding of the nature of the work being undertaken, including potential problems and quality control concerns in providing services for the management and reporting of clinical trials data, auditing clinical trials at the Consortia sites, and developing and implementing Task Area-specific training materials and/or programs.

In addition, the Technical Proposal should be in sufficient detail to indicate how services in each task area of the SOW are to be accomplished, and include information on how the project is to be organized, staffed, and managed to ensure successful completion of the work of each task area as well as the coordination and integration of all project activity.

Attachment 8: Additional Technical Proposal Instructions Page 2 of 3

RFP Number: N02CN35003-43

B. PERSONNEL

The Technical Proposal should include a Staffing Plan for the conduct of the Task Order Statement of Work with descriptions of the roles, responsibilities, and level of effort of personnel, including technical personnel of all proposed subcontractors.

All information relevant to document individual education, training, experience, qualifications and expertise necessary for the successful completion of all contract requirements should be included. Identify who is to be assigned as key personnel, and limit CVs for these key personnel to 2-3 pages, and include recent experience with projects of similar scope, size and complexity as that of the Request for Proposal (RFP). The CV’s for other than key personnel should be limited to one page.

1. Project Manager (key personnel)

Describe the education, training, experience, expertise, qualifications and level of effort of the proposed Project Manager to lead and direct the activities to be carried out under this contract, including managing and coordinating the efforts of personnel required to perform the activities described in the Statement of Work.

2. Task Area Managers (key personnel) and Other Technical Personnel

Describe the education, training, experience, expertise, qualifications and level of effort of proposed key technical personnel of the Offeror and all proposed subcontractors, including relevant qualifications and experience with projects of similar size and scope that document capability to meet the requirements of the SOW. In addition, relevant qualifications and experience specific to data management and reporting, IT systems development, maintenance and security, clinical trials auditing, and education and training should be documented.

C. CORPORATE BACKGROUND AND EXPERIENCE

The Offerors should document their corporate experience in each of the task areas of the Statement of Work including:

1. auditing and data verification services for cancer prevention and other clinical trials,

2. education and training of staff conducting cancer prevention and other clinical trials,

3. data management of clinical trials using Oracle Clinical-Remote Data Capture and/or electronic clinical data management systems,

4. the development, maintenance and integration of data transfer and reporting mechanisms, and

5. prior experience with projects of similar size, scope and complexity.

D. FACILITIES AND EQUIPMENT

The Offerors shall provide a description of their facilities, software and equipment that are available or will be provided to support all requirements of the SOW and the Technical

Attachment 8: Additional Technical Proposal Instructions Page 3 of 3

RFP Number: N02CN35003-43

Proposal. The Offerors shall emphasize facilities, equipment, processes and procedures that address, promote, and ensure:

1. Management of clinical trials data using OC-RDC (V4.6 or later),

2. Data transfer and reporting,

3. Data security,

4. Disaster recovery for systems and operations, and

5. Communication and collaboration with DCP, including DCP contractors supporting other elements of DCP’s clinical trials program

In addition, a description of any specialized facilities and equipment necessary to address specific technical requirements of the SOW shall be provided.