A11_-_Additional_Technical_Proposal_Instructions.pdf

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The Offeror shall submit a proposal that describes in detail the capability of the Principal Investigator (PI) and the Offeror to provide and oversee all activities of their clinical research unit capable of responding to Task Order Requests for Proposals (TORFPs), and executing successfully SAD and SAD/MAD Phase I clinical trials in a timely fashion. The ability to provide a full range of services in a turn-key manner to support the Phase 1 clinical trials under this solicitation, and reporting the results to regulatory agencies shall be described thoroughly.

1. Technical Approach

The Offeror shall:

Document technical understanding and demonstrate evidence of capabilities (data from 2016-present) to write, implement, conduct, analyze, complete, provide oversight, and perform laboratory analysis for Phase 1 clinical trials to determine the tolerated dose range, the dosing regimen, the safety profile and PK/PD outcomes of investigational agents, including adequacy, suitability, feasibility, and appropriateness of plans and procedures to:

a) Demonstrate ability to develop study design elements, justifications, schedule events and timelines, perform safety assessments, and complete a safety reporting plan, sample informed consent form, and case report forms for the clinical trial indicated in Sample Task Orders B-1 and B-2

b) Carry out the specific tasks and functions indicated in Sample Task Orders B-1 and B-2, including adherence to current Good Clinical Practices (cGCP), and ability to receive, control and monitor storage, dispense, and maintain inventory of clinical trial investigational agents and clinical samples and specimens

c) Develop concept proposals into full clinical protocols for clinical trials that will be conducted in accordance with NIH, NINDS and other federal, state, and local, clinical research policies, templates, and requirements

d) Demonstrate previous experience and proposed processes for development, validation, clinical sample testing, and data analysis for bio-analytical assays

e) Access, recruit and retain at least 80 clinical trial participants including healthy volunteers annually from the general population

f) Identify anticipated recruitment and retention problems and proposed approaches to overcome or minimize anticipated problems and difficulties

g) Provide for quality assurance/quality control (QA/QC), including ensuring all clinical and assay data generated meet all regulatory and other required standards; and establishing, implementing and maintaining Standard Operating Procedures (SOPs), processes for internal audits, remediation procedures, accommodation of Sponsor or sponsor designated clinical site monitors and auditors, and procedures for study analysis and close-out

h) Demonstrate capabilities to develop specific SOPs and Project Management Plans

i) Proposed approach to and demonstrated understanding of developing concepts that contain sufficient information to assess feasibility and serve as the basis for protocol development

j) Approach for soliciting, evaluating, negotiating, awarding, managing, identifying and remediating performance issues, and terminating subcontracts in accordance with Federal regulations

k) Demonstrate the capacity to support concurrently multiple Phase I clinical trials

l) Demonstrate previous experience and proposed processes for resolving unanticipated situations related to operational readiness and contingency planning and

m) Provide closeout and archival plans

2. Personnel Qualifications

The Offeror shall:

Document adequacy, availability, qualifications, experience, education and competence of the professional, technical, administrative and other personnel of the investigative team, including proposed subcontractors and consultants (as evidenced by resumes, endorsements and explanations of previous efforts).

Document the soundness of the number and mix of personnel, the proposed staff time or labor hours. This includes:

a) Principal Investigator (PI): The appropriateness and adequacy of the education, training, experience, expertise, and qualifications of the proposed Principal Investigator with respect to:

1) Designing, implementing, conducting, analyzing, and completing iPhase I clinical trials to assess safety, pharmacokinetic, and pharmacodynamics outcomes of neurotherapeutics, including small molecules and biologics.

2) Providing oversight and ensuring adherence and compliance with all applicable clinical trial regulations and policies; leadership experience in identifying issues and performance problems, implementing corrective actions, identifying qualified personnel, interacting with clinical research staff at affiliated sites; maintaining active licensure and cGCP and human subjects protection (HSP) training; and the proposed level of effort.

b) Other Scientific and Technical Personnel: The appropriateness and adequacy of the education, training, experience, expertise, qualifications, and level of effort of the proposed scientific and technical personnel (including physician and clinical pharmacologist) of the offeror and all proposed subcontractors, including the adequacy of the proposed mix of staff, training, expertise, and experience to carry out contract requirements with respect to:

1) Implementing (including clinical trial investigational agent and clinical specimen requirements), conducting, and analyzing data from Phase I clinical trials in accordance with all applicable federal, state, and local regulatory regulations (including FDA regulations, ICH GCP guidelines and NIH and NINDS policies) governing the safe conduct of research involving human subjects and protocol specific requirements for the conduct of research involving human subjects;

2) Developing, maintaining and supporting business systems to collect data as it pertains to each specific protocol, including data entry, management and quality control; maintaining active licensure, certification and cGCP and HSP training; and the proposed level of effort. Receipt, storage, preparation, transport and quarantine of study product.

3. Organizational Capabilities and Resources

The Offeror shall:

a) Demonstrate capabilities to provide overall project management and administrative functions and activities for the specific requirements.This includes:

1) Proposed systems for tracking project activities and monitoring progress, timelines and budgets, including project management controls to keep multiple project tasks on time and on budget.

2) Plans and proposed processes and procedures for project management, including proposed organization and staffing, leadership and lines of authority to ensure efficient planning, initiation, implementation, conduct, and completion of all proposed activities.

3) Plans for establishing lines of communication between the Principal Investigator(s), key staff, Contracting Officer's Representative (COR), the Contracting Officer, and NINDS staff, as well as establishing lines of communication and authority between subcontractors.

4) Organizational experience working with proposed consultant(s) and subcontractor(s) and the technical benefits of any such proposal as well as plans to mitigate associated performance risks

5) Able to provide system of records for all documentation required for the conduct of clinical trials and produce submission ready documentation of trial results.

6) Plan to ensure all federal, state, local, and NINDS site safety reporting, policy, and regulatory requirements are met, including IRB approval and regulatory documents binder completion prior to study start, staff training, IRB approval of subsequent amendments, safety reporting to IRBs and NINDS, identification of an Independent Safety Monitor (ISM), and participation and support of safety oversight committees.

7) Plan to ensure protection of Contributors intellectual property and data procedures.

b) Demonstrate the capability to perform concurrent clinical trials that would be sponsored under this solicitation.

c) The availability, adequacy and suitability of the clinical research facilities, equipment and other resources for the conduct of clinical trials, as applicable and appropriate to the specific requirements and Sample Task Orders 1-3, including those of proposed subcontractors. This includes:

• Clinical research facility;

• Clinical laboratory facility;

• Research laboratory facility;

• Research pharmacy facility;

• Clinical imaging facility;

• Data management center and archival storage facility

d) Describe facility access:

Plans and procedures for accessing facilities, services and other resources, including subcontracted facilities and services, as appropriate to meet protocol requirements. In addition, describe the process for determining the need to add sites as required by the protocol.