Attachment 2 -Technical Evaluation Criteria.pdf

Clinical Research and Study Monitoring 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:

Factor 1: Technical Approach

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: Management Approach

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.

a) 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 monitoring contracts and in monitoring of clinical trials and research studies for mental health and psychiatric disorders.

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

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

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 the successful monitoring of clinical research studies.

2) Contractor’s experience in the monitoring of clinical trials and research studies for mental health and psychiatric disorders.

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