Att_03 - Technical Evaluation Criteria.pdf

Attachment 3

TECHNICAL EVALUATION CRITERIA

Technical Evaluation Criteria The criteria are listed in order of relative importance and will be used to evaluate proposals/quotes.

Note: The Technical Evaluation Panel will be evaluating your responses to Task Order 1, Task Order 2, and Task Order 3 as part of the evaluation process.

CRITERION 1: PERSONNEL

The offeror shall identify the personnel proposed in accordance with the solicitation requirements and provide information sufficient for the Government to evaluate their qualifications, experience, proposed roles, and availability.

The Government will also evaluate the qualifications and experience of proposed personnel and the extent to which the proposed team possesses the expertise necessary to perform the requirements of the IDIQ and Task Orders.

The evaluation will consider, as applicable:

• Education, professional qualifications, and relevant technical expertise;

• Experience supporting clinical research studies and clinical trials;

• Experience with protocol monitoring, clinical data management, regulatory affairs, IND/IDE activities, DSMB support, and/or statistical analysis, as applicable to the proposed role;

• Relevant experience with genetic conditions, rare diseases, gene therapy, pediatric and adult clinical research, clinical trials, gene and cell-based therapies, social and behavioral research, and other areas applicable to NHGRI's requirements;

• Experience working within applicable Federal, NIH, FDA, and clinical research regulatory environments;

• Qualifications and experience of proposed senior-level statisticians, preferably with a Ph.D. in statistics or directly relevant and related field.

• Appropriateness of assigned roles and responsibilities.

• Availability and commitment of proposed personnel.

The Government will also evaluate whether the overall proposed team provides an appropriate combination of disciplines and expertise to perform concurrent requirements across the Task Areas.

CRITERION 2: TECHNICAL AND MANAGEMENT APPROACH

The Government will evaluate the offeror's approach to managing the IDIQ and individual task orders to ensure timely, high-quality, and consistent performance. The Government will evaluate the following:

• Ability to perform the applicable requirements of Task Areas 1 through 4 of the parent

SOW.

• Ability to address protocol monitoring and data management; IND/IDE regulatory support; DSMB support; and statistical consultation, analysis, and reporting

• Ability to provide regulatory support for INDs, IDEs, or related clinical research activities

• Ability to coordinate and support a Data and Safety Monitoring Board (DSMB)

• Ability to provide statistical consultation, analysis, and support for clinical or behavioral research.

The evaluation will consider:

• Approach to transition-in and transition-out activities including identification of transition risks and associated mitigation strategies as well as approach for assuming performance with minimal disruption to operations.

• Approach to task-order management, coordination, and oversight;

• Approach to managing multiple simultaneous requirements and competing priorities;

• Methods for assigning, monitoring, and adjusting staffing and resources;

• Approach to quality control and quality assurance of technical products and deliverables;

• Processes for identifying, escalating, tracking, and resolving performance issues and risks;

• Approach to monitoring schedules, deliverables, and action items;

• Approach to communicating status, risks, and required Government actions;

• Approach to continuity of operations and personnel coverage;

• Approach to replacing personnel and obtaining specialized expertise when required.

CRITERION 3: OFFEROR EXPERIENCE

The Offeror will be evaluated on their relevant contract experience supporting NIH studies as well as research related to: human genetics and genomics, rare and severe genetic diseases, pediatric populations, gene and cell-based therapy, and ethical, legal, and social implications.

The Government will consider the similarity of the work to this requirement, including its scope and complexity.

For each of the examples provided, describe the following:

• Name and address of organization supported

• Description of the project, including the types of patients/research subjects involved

• Contract or project number

• Contract value or approximate project value

• Period of performance and duration of engagement

• Description of the services performed and the Offeror’s role;

• Identification of the Task Areas or similar functions supported;

Describe how the scope, complexity, research setting, and coordination requirements of each example are similar to or different from the requirements of this IDIQ.

CRITERION 4: PAST PERFORMANCE

The Offeror’s past performance will be evaluated based on information contained in the Offeror's proposal and the information that the government obtains through other means, to include but not limited to information contained in the Contractor Performance Assessment Reporting System

(CPARS).

The Government will assess the recency and relevance of the examples and the Offeror’s record of technical quality, timeliness, management of concurrent work, and resolution of performance problems. An Offeror for whom past performance information is unavailable, will be evaluated neither favorably nor unfavorably on past performance. Please provide the following information on no more than 3 of your most recent and relevant contracts.

• Name and address of organization supported

• Title of the project

• Contract or project number

• Contract value or approximate project value

• Period of performance and duration of engagement

• Name, title, email address, and telephone number of a customer point of contact; and

• Any significant performance problem, its effect on the work, and the corrective action taken.