Attachment 2 - Technical Evaluation Selection Criteria.pdf

Financial and Clinical Monitoring Activities Support for NIMH Studies

Technical Evaluation Criteria

The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below: The proposal should be no longer than 10 pages, excluding key personnel resume(s)/curriculum vitae.

Factor 1: Technical Approach (30 Points)

The Contractor’s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. The proposed technical approach shall be evaluated for the appropriateness and effectiveness of the overall approach as well as the methods, procedures, and resources proposed for performing the tasks described in this solicitation.

Factor 2: Key Personnel (30 Points)

The Contractor’s proposal shall provide a management plan detailing the proposed management approach as well as a draft training plan and quality control plan. The management plan shall cover key personnel that are able to provide the following:

document experience, educational background and training, and availability of the proposed staff and their designated responsibility on the project. This includes the education, experience, managerial competence and time commitment of the proposed manager and the experience, technical competence, and time commitment of other staff; staff expertise in travel logistics. In addition the plan will include plans for adequate communication with the Government, contractor staff management and training, and quality control. The management approach shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work, as well as the appropriateness and effectiveness of communication/problem resolution, and staff management and training to ensure quality performance of required efforts. Offeror proposals must contain resumes/CVs for key personnel proposed.

The Supervisory Program Manager must have a master’s degree in a relevant scientific discipline and extensive experience (approximately 10 or more years) in overseeing clinical research monitoring, auditing, and/or oversight. Preferably experience specific to the monitoring of clinical trials and research studies for mental health and psychiatric disorders. This position requires expert communication skills and organizational abilities including the ability to track the audit trail for the multiple reports received, reviewed, and finalized. This project with have multiple streams of information considering both the clinical research study audit and the financial audit reports and the Supervisory Program Manager is required to track the progress of all reports.

NOTE: During the first ninety (90) days of the contract performance period no key personnel substitutions by the contractor will be made unless such substitutions are necessitated by an individual’s sudden illness, death or termination of employment.

Factor 3: Past Performance (40 Points)

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work.

References shall include the following information:

a) Name of Organization

b) Description of Contractor’s Responsibilities as they related to this SOW

c) Contract Period of Performance

d) Contact Name and Title

e) Telephone Number

f) E-mail address

Past Performance shall be evaluated for relevance to the current requirement, length of experience, and customer satisfaction in reference to the following:

1) Contractor’s experience in for-cause (audits) monitoring of clinical trials and research studies for mental health and psychiatric disorders.

2) Contractor’s experience in the evaluation of proposed corrective and preventive action (CAPA) plans and providing additional recommendations

3) Contractor’s experience in conducting financial audits

4) Contractor’s experience in exceptional oral and written communication

Evidence of expertise with regulatory approval processes associated with clinical research as well as human subjects protection regulations and good clinical practice guidelines.

Technical proposals will be evaluated using an adjectival rating in accordance with the following scale:

High Confidence- The Government has high confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with little or no Government intervention.

Some Confidence -The Government has some confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with some Government intervention.

Low Confidence - The Government has low confidence that the Offeror understands the requirement, proposes a sound approach, or will be successful in performing the contract even with Government intervention.

Contracting Officer’s Representative:

Ashley Kennedy National Institute of Mental Health Clinical Trials Operations Branch 6001 Executive Boulevard Rockville, Maryland 20892-9649 Email: ashley.kennedy@nih.gov Phone: 301-443-3366

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this purchase order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this purchase order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this purchase order; (5) otherwise change any terms and conditions of this purchase order; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the purchase order.

The Government may unilaterally change the COR designation for this purchase order.

mailto:bodensteiny@mail.nih.gov