EPCTU RFP Attachment 14 Evalaution Factors for Award Revised.pdf
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- Early Phase Clinical Trial Units (EPCTU)
- Solicitation number
- RFP-NIAID-NIH-AI-75N93020R00023
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This document outlines the evaluation factors for a request for proposals for Early Phase Clinical Trial Units issued by the National Institute of Allergy and Infectious Diseases. Offerors are invited to provide clinical trial support services across five task areas: administrative support, Phase 0 to Phase I trials, Phase I/II trials, Phase II trials, and Phase III trials. Proposals will be evaluated on technical approach, personnel qualifications, project management approach, and facilities. Top scoring proposals will be considered for contract awards to provide services including protocol development, regulatory management, clinical data management, laboratory services, and reporting for early-phase infectious disease studies. The contracting period is not specified but incumbents may be subject to site visits and audits during performance.
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Evaluation Factors for Award RFP No. NIHAI75N93020R00023
ATTACHMENT 14: SECTION M - EVALUATION FACTORS FOR AWARD
EARLY PHASE CLINICAL TRIAL UNITS (EPCTU)
RFP- NIHAI75N93020R00023
A. GENERAL
Selection of an offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: technical, cost, and past performance.
Although technical factors are of paramount consideration in the award of the contract, past performance, and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost. The Government intends to make award(s) to the offeror(s) whose proposal(s) provide the best overall value to the Government.
The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Proposals will be evaluated in their entirety, including proposals for actual and sample task orders, as well as Options. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below.
PRE-AWARD SITE VISIT OR SITE AUDIT
Following completion of the scientific/technical peer review and after determination of the Competitive Range for individual Task Area Awards, Offerors may be subject to a pre-award site visit or auditing of their facilities and Quality Assurance and Quality Control (QA/QC) capabilities. The decision to conduct a pre-award site visit or audit specific facilities after determination of the Competitive Range will be made by the Contracting Officer’s Representative. Offerors, including proposed subcontractors, will be requested to make all non-proprietary records, including previous regulatory inspection records, and staff available in response to a pre-award site visit or audit by the NIAID or its designee. Due to timeline requirements, pre-award site visits may be made with short notice. Offerors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.
B. TECHNICAL EVALUATION CRITERIA
The evaluation criteria will be used by the technical evaluation committee when reviewing the technical proposals. The criteria are listed below in the order of relative importance with weights assigned for evaluation purposes. Sub-factors are listed in order of relative importance.
OFFERORS AND REVIEWERS ARE ADVISED TO REFER TO - Additional Technical Proposal Instructions – OF THIS SOLICITATION PACKAGE FOR GUIDANCE AND
INFORMATION RELATED TO THE PREPARATION OF TECHNICAL PROPOSALS.
TECHNICAL EVALUATION CRITERIA WEIGHT
CRITERION 1: TECHNICAL PLAN/APPROACH
Appropriateness, feasibility, and adequacy of the proposed technical plan/approach for accomplishing the tasks outlined in the Statement of Work and the overall objectives of the solicitation including capacity and capability for a broad range of services necessary to support and conduct clinical trials and bioanalysis and when needed, conduct domestic or international natural history, or observational studies. Adequacy of proposed plan to address relevant biological variables, including sex for studies in human subjects as applicable.
CRITERION 2: SCIENTIFIC AND TECHNICAL PERSONNEL
Appropriateness and adequacy of the education, training, experience, expertise, and proposed levels of effort of the Principal Investigator and scientific and technical staff including subcontractors/consultants for accomplishing the tasks outlined in the Statement of Work and the overall objectives of the solicitation.
CRITERION 3: PROJECT MANAGEMENT
Appropriateness and adequacy of the plans for Project Management in terms of staffing, organizational structure and lines of authority, management of subcontracts/consultants, tracking of project activities, monitoring progress and timelines, and communication with stakeholders.
CRITERION 4: FACILITIES, EQUIPMENT, AND OTHER
RESOURCES
Appropriateness and adequacy of facilities, equipment, space and other resources including those of subcontractors/consultants for accomplishing the tasks outlined in the Statement of Work and the overall objectives of the solicitation.
TOTAL POSSIBLE 200
A. Other Evaluation Factors:
HUMAN SUBJECT EVALUATION
Protection of Human Subjects from Research Risks, Data and Safety Monitoring, Women and Minorities, Children
EVALUATION OF DATA SHARING PLAN
EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL
RESEARCH
EVALUATION OF FOREIGN CURRENCY OFFERS, FAR 52.225-17, (FEBRUARY 2000)
Use when foreign currency offers are anticipated and allowed. This factor describes the currency conversion procedures.
COST FACTOR
PAST PERFORMANCE FACTOR
EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION
SUBCONTRACTING PROGRAM EVALUATION CRITERIA
Use when additional evaluation of the offeror’s subcontracting program is warranted and desired
Cost Factor Offeror(s) cost/price proposal will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in
FAR 15.404.
Cost will be evaluated based on Cost Realism. The specific elements of each Offeror(s) proposed costs are realistic when the proposed cost elements are evaluated and found to: 1) be realistic for the work to be performed; 2) reflect a clear understanding of the requirements; and 3) be consistent with the unique methods of performance and materials described in the Offeror(s) technical proposal.
Cost Realism will be evaluated only on the Offeror(s) inputs which the Government will use to determine the most probable cost to perform the contract in a manner consistent with the Offeror’s proposal. A cost realism analysis will be conducted in accordance with FAR 15.404-1(d). The result of the cost realism analysis will be considered in the making the best value tradeoff decision
Past Performance Factor
Offeror's past performance information will be evaluated subsequent to the technical evaluation.
However, this evaluation will not be conducted on any Offeror whose proposal is determined to be technically unacceptable.
The evaluation will be based on information obtained from references provided by the Offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the Offeror concerning problems encountered on the identified contracts and corrective action taken.
The Government will assess the relative risks associated with each Offeror. Performance risks are those associated with an Offeror’s likelihood of success in performing the acquisition requirements as indicated by that Offeror’s record of past performance. The assessment of performance risk is not intended to be the product of a mechanical or mathematical analysis of an Offeror’s performance on a list of contracts but the product of subjective judgment by the Government after it considers all available and relevant information.
When assessing performance risks, the Government will focus on the past performance of the Offeror as it relates to all acquisition requirements. These include the Offeror’s record of performing according to specifications, including standards of good workmanship; the Offeror’s record of controlling and forecasting costs; the Offeror’s adherence to contract schedules, including the administrative aspects of performance; the Offeror’s reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the Offeror’s business-like concern for the interest of the customer.
The Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the Offeror’s performance.
The lack of a relevant performance record may result in an unknown performance risk assessment, that will not be used to the advantage nor disadvantage of the Offeror.
Offeror is to submit any relevant past performance information in the business proposal when responding to this RFP
Subcontracting Program Evaluation Factor
The offeror's proposed Small Business Subcontracting Plan will be evaluated to determine whether it represents the maximum practicable opportunity for subcontracting. Because the offeror's record of previous performance in carrying out the intent of the subcontracting program will be considered as a significant sub-factor, each offeror is encouraged to submit subcontracting plans and documentation that demonstrates their prior corporate support for small, small disadvantaged, women-owned small, HUBZone small, veteran-owned small, and service-disabled veteran-owned small business suppliers.
If offers are received from both large and small businesses, the small business offerors shall receive the maximum possible number of points for this factor.
Extent of small disadvantaged business participation
SDB participation will not be scored, but the Government's conclusions about overall commitment and realism of the offeror's SDB Participation targets will be used in determining the relative merits of the offeror's proposal and in selecting the offeror whose proposal is considered to offer the best value to the Government.
The extent of the offeror's Small Disadvantaged Business Participation Targets will be evaluated before determination of the competitive range. Evaluation of SDB participation will be assessed based on consideration of the information presented in the offeror's proposal. The Government is seeking to determine whether the offeror has demonstrated a commitment to use SDB concerns for the work that it intends to perform.
Offers will be evaluated on the following sub-factors:
a. Extent to which SDB concerns are specifically identified
b. Extent of commitment to use SDB concerns
c. Complexity and variety of the work SDB concerns are to perform
d. Realism of the proposal
| The Contractor and all affiliated clinical sites participating in the conduct of approved protocols shall provide malpractice insurance and indemnification for trial-related injuries to subjects. The Contractor shall provide evidence of its insurance ... |
| ATTACHMENT 3: SAMPLE TASK ORDER B |
| ATTACHMENT 4: SAMPLE TASK ORDER C |
| Duration of Treatment |
| Table 5. Schedule of Assessments and Procedures for Cohorts 1 and 2 in Part 2 |
| Table 6. Schedule of Assessments and Procedures for Cohort 3 in Part 2 |
| Table 7. Schedule of Assessments and Procedures in Part 3 |
| ATTACHMENT 5: SAMPLE TASK ORDER D |
| Table 1: Study Groups |
| Key Inclusion Criteria for Patients |
| Key Inclusion Criteria for Non-Hepatically Impaired Controls (Group 4): |
Key Exclusion Criteria for Patients
| [End of the Statement of Work for Sample Task Order D] |
| ATTACHMENT 6: SAMPLE TASK ORDER E |
| 1) Develop all necessary sensitive assays required for clinical sample analyses as per protocol such as measurements of drug levels for PK/PD assessments and any nucleic acid methodology necessary to quantify Infection-A in urine such as: electrochemi... |
| 2) Select a qualified bioanalytical facility to accept the transfer of assays, and validate the transferred assays. |
| 3) Perform Method Validation: |
| Study Outcome Measures: |
| Primary Outcome Measures: The proportion of participants with eradication of Infection-A in each study arm at Visit 2 (Day 15-21) as assessed by NAAT or culture. |
| Secondary Outcome Measures: The proportion of participants reporting related adverse events (AEs and SAEs) in each study arm following the first dose of study product through Visit 2 (Day 15-3030); pharmacokinetic parameter (AUC, Cmax and C min) of ... |
| Exploratory Outcome Measures: Time to clearance of Infection-A from the urine |
Key Inclusion Criteria
| 1) All reports and items generated during the Task Order. |
| 2) All computerized data files, original data, and any necessary information related thereto. |
| 3) Any product of the Task Order, such as clinical specimens (blood, urine samples etc.), concentration data, dosing data, subject demography data; institutional review board (IRB) approvals, IRB submissions, monitoring reports; Clinical Study Report ... |
| 4) Paper and electronic files covering all aspects of clinical study generated under the Task Order; provided in a compatible format as requested by the COR such as SAS, .csv and others; |
| 5) All data obtained from clinical studies, including all non-proprietary study data; |
| 6) A complete list of accurate and updated information regarding design, development and conduct of studies (including pertinent Contractor activities, computerized data files, original data), and any related information such as the submissions for Tr... |
| 7) A complete list of accurate and updated information on activities performed by Subcontractors. |
| 8) Labeled and inventoried paper files. |
| A. GENERAL |
| Extent of small disadvantaged business participation |
| 1. Task Area A: Administrative and Overall Clinical Operations Support and Concept Development: |
| Offerors are expected, either directly or through subcontracts, to provide all the activities that are described in the Task Area A SOW. Offerors should indicate clearly in the Technical Proposal whether they are performing the clinical trial activiti... |
| 2. Task Area B, C, D, and E: Phase 0 to Phase I, Phase I/II, Phase II (or III) clinical trials: |
| Clearly identify the specific Task Area(s) (B, C, D or E) to which the offeror is responding. Offerors are expected either directly or through subcontracts to provide all the activities that are described in the Task Area B, C, D, or E SOW. Offerors... |
| The Technical Proposal for Task Area B, C, D and E should address all elements in the Task Area SOW, including the general requirements, and provide a detailed technical plan to address each of the activities within the Scope of Task Area. |
| Respond to the requirements for Sample Task Order B, C, D, or E (Phase 0, I, I/II, II or III Studies). The proposal should address general technical requirements in the SOW for Task Areas B, C, D or E, and a separate technical response that demonstrat... |
| DATA SUBMISSION INSTRUCTIONS |
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