Attachment_11_ATPI_N02CN85003-39.pdf

Attachment 11: Additional Technical Proposal Instructions Page 1 of 6

RFP N02CN85003-39

Attachment 11 Additional Technical Proposal Instructions

Protocol Information Office (PIO) Support Services

SECTION 1 – GENERAL INSTRUCTIONS

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, proposal part, and identify if the proposal is an original or a copy.

B. PROJECT OBJECTIVES (NIH FORM 1688-1)

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

E. TABLE OF CONTENTS

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section. Cost and Pricing support should be provided for all proposed subcontractors.

SECTION 2 - TECHNICAL APPROACH

General:

A detailed work plan must be submitted indicating how each Project Area of the Statement of Work is to be accomplished. The technical approach should be in as much detail as necessary to fully explain the proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. In addition, the technical proposal must include information on how the project is to be organized, staffed, and managed, thus demonstrating understanding and plan for management of each Project Area.

A. Adequacy of Technical Approach and Understanding of the Project The proposal should include: 1) a statement of the overall objectives of the project, as envisioned by the Offeror; and 2) an outline of the technical approach that will be used to achieve the objectives.

Proposals should address each Project Area of the Statement of Work in a manner that describes the Offeror's approach and methods of quality control for the various tasks outlined in each Project Area. The Offeror should demonstrate a clear understanding of the needs of the program and an understanding of the potential problems involved with these types of projects.

Specifically, the Offeror should discuss its:

1. Approach - A detailed work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. The technical approach should be in as much detail as necessary to fully explain the proposed technical approach or method. The technical proposal should reflect a clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed. Information should be provided which will demonstrate understanding and plan for management of important events or tasks.

The Offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed and methods of quality assurance, in achieving the project

Attachment 11: Additional Technical Proposal Instructions Page 2 of 6 objectives. The Offeror should demonstrate a clear understanding of the potential problems and solutions involved with these types of projects. Proposals which merely restate the requirements of the Government's Statement of Work will not be eligible for award.

Specifically, the Offeror should discuss its technical understanding of the requirements of the project, which includes: an understanding of the oncology community and cancer clinical research; an explanation of the methods and approach for accomplishing the tasks outlined in the Statement of Work, in a secure, flexible and user-friendly environment. The Offeror should state their ability to meet with Division of Cancer Prevention (DCP) personnel on short notice, if needed. The Offeror should discuss its plan for start-up of work under this contract. The Offeror should discuss its understanding of Quality Assurance (QA) methods, goals and objectives. Specific descriptions of how the Offeror will ensure that work performed will meet or exceed the Quality Assurance standards shall be addressed.

Development of a QA plan, evaluation of activities covered in the QA plan, and methods used to update the QA plan, in accordance with the indicators measured in the QASP, shall be addressed. The Offeror should discuss its plan to optimize data quality and ensure timeliness of projects and tasks, as detailed in the Statement of Work. The Offeror should discuss the ability of the Program Manager, Deputy Program Manager and all other contract staff to provide daily contact with DCP staff, as needed, to discuss and advise on the administrative and operational aspects of the protocol development process as it impacts DCP operations and data abstraction processes. The Offeror should discuss its experience with and ability to provide best business practices regarding process improvement, continuous quality improvement principles, and change management practices. The Offeror should submit an example of three new QASP measures which show their understanding of PIO tasks and their importance to the DCP Program goals. The Offeror should discuss how its management plan provides the Project Officer with up-to-date financial information, project/subproject status and staffing information. The Offeror should discuss its plan for providing annual training programs (including orientation of new personnel) to DCP personnel, DCP contractors, or submitters and submitter personnel who interact with DCP.

The Offeror should discuss its proposed transition plan to support a smooth transfer of responsibility for the project to a new Contractor upon completion of the contract.

Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. and possible or probable outcomes of approaches proposed.

2. Methods - Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and potential solutions any unusual expenses you anticipate.

3. Schedule - Provide a schedule for completion of the work and delivery of items specified in the statement of work. Performance or delivery schedules shall be indicated for phases or segments, as applicable, as well as for the overall program. Schedules shall be shown in terms of calendar months from the date of authorization to proceed or, where applicable, from the date of a stated event, as for example, receipt of a required approval by the Contracting Officer. Unless the request for proposal indicates that the stipulated schedules are mandatory, they shall be treated as desired or recommended schedules. In this event, proposals based upon the Offeror's best alternative schedule, involving no overtime, extra shifts or other premiums, will be accepted for consideration.

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4. Provide a detailed description of how the Contract performance standards will be maintained during fluctuations in the personnel needs as a result of high or low levels of requests, etc. Also explain in detail the plan for maintaining performance standards during periods of extended absences or departures by personnel. For personnel proposed as "backup" personnel to key positions, Curriculum Vitae or resumes should be provided.

5. Provide a communications plan on how the Offeror plans to effectively communicate with the its team, the customer, stakeholders, and others. Specifically, Offeror shall describe how it will be able to meet with DCP personnel during an emergency or closure by use of available technologies (teleconference, WebEx).

B. Personnel and Experience At the time of proposal submission, the Offeror must provide letters of intent from each proposed personnel indicating the availability of the personnel to perform the work at 9609 Medical Center Drive, Rockville, MD 20850 for the potential life of the contract (five years).

Each Project Area of the Statement of Work should be addressed in sufficient detail to permit the evaluation of the proposal in terms of the adequacy and availability of all staff assigned to the project. Indicate the approximate percentage of total time each person will be available for this contract and specifically to which project area(s) each employee is assigned. Also, demonstrate whether (and which) Offeror’s employees are available on short notice, and under conditions of multiple and competing project areas. Within the total level of effort, Offerors should indicate the specific level of effort that they consider appropriate for each function outlined in the Statement of Work.

The Offeror should consider the complexity of this project when selecting qualified personnel.

The Government assumes that it will take a staff with varied backgrounds to complete the project area tasks in a timely and effective manner. Contract staff should have a wide breadth of training and experience in web-based databases, document management, quality control, workflow management, and clinical trials. Skills that are essential to successful performance of this contract include problem solving, attention to detail, organization, teamwork, and multitasking.

- Describe the composition of the proposed work group, its general qualifications, and recent experience with similar programs/equipment.

- Provide a Personnel Matrix, naming the proposed employees, which indicates the hierarchical line of supervisory authority, and indicate which Offeror’s employee(s) will perform the various tasks. If appropriate, provide a hierarchical line of supervision authority with subcontractor employees.

- Describe the experience and qualifications of all personnel who will be assigned to this project. Indicate which personnel are considered to be Key Personnel. In addition, provide complete and detailed resumes for the Project Manager and all other senior level personnel, indicating their recent experience associated with clinical trials, document management, information management and database abstraction.

- Provide documentation of the availability on a full-time basis for this project for all proposed individuals (including letters of intent and other commitments if not already full-time employees).

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Because of the complex and detailed nature of the tasks involved, employees will require considerable instruction and orientation to function efficiently. A stable work force is therefore necessary. Indicate the employment stability of all personnel assigned to this project by evidence of continued service with Offeror’s organization or another organization.

OFFERORS SHOULD ASSURE THAT THE PROJECT MANAGER AND ALL OTHER PERSONNEL

PROPOSED SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE

THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED

THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME,

THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE

TIME COMMITMENT.

Provide complete detailed resumes of the Project Manager and other specialists. Resumes should include educational background and related experience. In particular, experience with clinical trials or biomedical environment should be included. Include dates, places and names of previous employers, and any related training.

1. Project Manager (Key Personnel): - The Project Manager shall be an employee of the Offeror and not a consultant or subcontractor. List the name of the Project Manager who will be responsible for the overall implementation and management of the contract and the Offeror’s key contact for technical aspects of the program.

The Project Manager will be responsible for the staffing of the contract; monitoring hours and dollars charged to the contract; authorizing purchases within the scope of the contract;

and overall personnel management. He/she must have the authority to commit company resources as needed for efficient and timely completion of work under this contract. His or her experience must be able to demonstrate the ability to delegate responsibility and authority. He/she must document sufficient knowledge and experience in clinical trials and document management-related administration. Specifically, he/she should document knowledge and experience in clinical trials development processes (both scientific and administrative); and knowledge and experience within the oncology community. He/she should document supervisory and problem-solving experience in an environment with shifting priorities. Documentation should be provided demonstrating their ability to supervise, instruct, and provide quality assurance to assure that tasks are performed efficiently and effectively. He/she must have experience with computer systems, including (but not limited to) Clinical Trial databases and MS Office®. Strong communication skills (written and verbal) are required. In addition, he/she should possess overall management capabilities which would permit effective implementation of all tasks outlined in the contract. He/she should document the level of education attained and knowledge of medical terminology. The Project Manager will be expected to participate in the daily work of the Protocol Information Office (PIO).

2. Deputy Project Manager (Key Personnel): - The Deputy Project Manager shall be an employee of the Offeror or a subcontractor, but may not be a consultant. List the name of the Deputy Project Manager.

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The Deputy Program Manager is responsible for assisting the Project Manager and serving in the Project Manager's capacity during the Project Manager's absence in the coordination of all activities pertaining to the work specified in the Statement of Work (SOW). He/she must have documented ability to delegate responsibility and authority. He/she must document sufficient knowledge and experience in clinical trials and document management-related administration. Specifically, he/she should demonstrate knowledge and experience in clinical trials development processes (both scientific and administrative aspects); and knowledge and experience within the oncology community. He/she must document supervisory and problem-solving experience. Documentation should be provided of ability to supervise, instruct, and provide quality assurance to assure that tasks are performed efficiently and effectively. He/she must have experience with computer systems, including but not limited to data element abstraction, milestone entry, generating queries, running canned reports, clinical trials databases and MS Office®. Strong communication skills (written and verbal) are required. In addition, he/she should possess overall management capabilities which would permit effective implementation of all tasks outlined in the contract. He/she should document the level of education attained and knowledge of medical terminology. The Deputy Project Manager is expected to participate in the daily work of the Protocol Information Office (PIO).

3. Document Specialists: - List the names of all Document Specialists who will be assigned to this project and describe their qualifications, experience, and accomplishments. State the estimated time each will spend on the project, their proposed duties on the project, and the areas or phases for which each will be responsible.

Document Specialists are responsible for the day to day performance of the tasks described in the SOW. Document Specialist workload will include, but not be limited to, abstraction of keywords and milestones into the DCP Clinical Trials Systems and Cancer Therapy Evaluation Program (CTEP) Enterprise/Abstraction System; serving as the central communication hub for all document-related correspondence; and as a facilitator of the entire protocol development process. Document Specialists should have a wide breadth of training and experience in clinical trials, document management, and knowledge of medical terminology.

Problem solving, attention to detail, abstraction accuracy, organization, and teamwork and multi-tasking skills should be demonstrated. Document Specialists must have experience with data entry and computer systems, including but not limited to data element abstraction, milestone entry, generating queries, running canned reports, clinical trials databases and MS Office®. Strong communication skills (written and verbal) are required.

Demonstration of their ability to effectively implement all tasks outlined in this contract is required.

4. The Offeror shall maintain a backup personnel system for key personnel and key positions.

Provide a detailed description of how the contract performance will be maintained during fluctuations in the personnel needs as a result of high or low levels of work, etc. Also explain in detail the plan for maintaining performance during periods of extended absences by personnel (defined as greater than 10 consecutive working days), as well as for personnel departures. For personnel proposed as "backup" personnel to key positions, curriculum vitae or resumes should be provided. Backups named must be thoroughly familiar with the position that they are supporting.

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5. The Offeror shall discuss potential problems and propose solutions related to personnel.

C. Organizational Experience Offerors shall describe in detail prior experience of the organization in furnishing services similar to those required by each area described in the Statement of work. The proposal should include sufficient information to demonstrate the previous effectiveness of the firm in similar or related work. Include documentation with specific reference to applicable contract numbers, dates of agreements and dollar volume. This documentation should include clear and concise descriptions of these projects and should indicate project sponsors (e.g., government contract or grant, etc.). Please note that organizational experience is defined as accomplishment of work, either past or ongoing, that is comparable or related to the effort required by this RFP.

Organization experience should also specify the size and scope of the project referenced and if the Offeror served as the prime or subcontractor. This includes overall Offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in the RFP. Offerors should demonstrate experience with clinical trials including but not limited to informatics supporting development processes, regulatory support efforts, and administrative/operations efforts.

The relationship of the proposed working group within the Offeror's organizational structure should be described as well as how this relationship may facilitate performance on this project.

Information should be provided on how staff training needs will be met. Additionally, the Offeror should explain how the corporate office’s expertise will provide support to this project and to the proposed Project Manager. The Offeror should explain how the organization will support the project manager in resolving problems or special situations. The Offeror shall demonstrate the availability of personnel proposed on the project.

D. Transition In The Offeror shall provide a transition phase-in plan to support a smooth transfer of responsibility from the incumbent contractor. It is anticipated that the new awardee will work with the incumbent contractor for one month during the transition in phase.