Pre-sol_Notice_75N95024R00086_1.pdf

Pre-solicitation Notice No. 75N95024R00086

"Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics"

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION

ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. 75N95024R00086,

ENTITLED: "Phase I Clinical Trials for Development of Small Molecule and Biologics Therapeutics" WILL BE ISSUED VIA www.SAM.gov ON OR ABOUT July 30, 2024 and will be conducted using full and open competition.

The National Institute on Neurological Disorders and Stroke (NINDS) has the need for a full service, turn-key phase I clinical trials operations and facility for the development of novel therapeutics. This full-service facility would support a full range of services from protocol development through submission of a final clinical study report.

The term therapeutics will include investigational agents developed by the National Institutes of Health (NIH) and its grantees and/or partners (henceforth known as the “Contributor(s)”) and provided to the NINDS for collaborative development as well as investigational agents supported by and through the NINDS. This includes the NIH Blueprint Neurotherapeutics Network https://neuroscienceblueprint.nih.gov/, the NINDS Ultra-rare Gene-based Therapy (URGenT) Network https://www.ninds.nih.gov/Current- Research/Research-Funded-NINDS/Translational-Research/urgent-network, the NIH Helping to End Addiction Long-term (HEAL) initiative https://heal.nih.gov/ or other programs as needed. The Phase I clinical trial investigational agents to be assessed may include small molecules and large biologic molecules (i.e., peptides, oligonucleotides, proteins, or other biologics). The results of these Phase I clinical trials will be the basis to advance candidate compounds for further clinical development (i.e., additional Phase I, Phase II/III clinical trials), and submitted ultimately to the FDA in support of a New Drug Application (NDA) or Biologics License Agreement (BLA) submission.

The scope of activities to be performed by the Contractor include the provision of a Phase I clinical research unit, the conduct of Phase I clinical trials of therapeutics, and the provision of a full range of services to support the clinical trials for investigational small molecules and biologics, including but not limited to peptides, oligonucleotides, proteins or other biologics, and reporting of the results to regulatory agencies.

These trials shall be designed to develop or assess tolerated dose range, the dosing regimen, safety profile and PK parameters. At the request of the Government, the trials may include PD measures, and evaluation of biological effects and early signs of efficacy. All clinical trials shall be carried out in a timely fashion and in compliance with all FDA regulations and International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidelines.

http://www.sam.gov/ https://neuroscienceblueprint.nih.gov/ https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/urgent-network https://heal.nih.gov/

The Contractor shall initiate work only when authorized by issuance of an approved task order. At contract initiation, the Contractor will be responsible for participating in a kickoff meeting and providing a contract-level project management plan (PMP). The Contractor shall only provide additional services if they are subsequently issued one or more task orders for individual clinical projects of investigational agents. It is anticipated that these task orders will be awarded through a competitive, Task Order Requests for Proposals (TORFP) process, will be cost- reimbursement/completion, fixed price, OR a combination of both, and will have variable periods of performance. NINDS anticipates issuing up to 2- 10 TORFPs during each year of the contract. The actual number of TORFPs issued will depend upon programmatic needs and funding availability and may vary from year to year.

The Contractor shall perform all activities associated with the conduct of Phase I clinical trials. Task Orders issued for “Clinical Projects” will consist of a base requirement for “Protocol Development and Trial Preparation” and include a quality-type option for “Clinical Trial Implementation”. Required activities are defined below and are to be considered general Technical Requirements that will be executed following issuance of individual Task Order awards. Each individual Task Order award will also define specific and additional technical requirements as appropriate for that Task Order Statement of Work.

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed, to perform the actions outlined below:

Contract Initiation

The Contractor shall:

i. Conduct a kick-off meeting to review the contract requirements, timelines, milestones, and deliverables; discuss the Contractor’s technical approach and project management plan;

and identify any anticipated difficulties in completing the contract requirements

ii. Provide a contract-level Project Management Plan (PMP) describing general procedures and processes of the vendor. (This isn’t trial-specific information; that is required below as part of the clinical project.) The contract PMP must be a single, well-organized document or folder that clearly connects document elements with the sections below. The PMP shall address and include, at a minimum, the following:

a. General standard operating procedures (SOPs) for the conduct of Phase I clinical trials and for all other integrated and collaborating services (such as pharmacy, database management, bioanalytic, etc.)

b. Personnel listing including their roles and responsibilities

c. General policies on human subject considerations (e.g., federal wide assurance

(FWA), procedures for managing medical emergencies on-site, reporting of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events, hospitalizations and procedures for prompt reporting of SAEs in compliance with FDA regulations and NIH policies)

d. General data management procedures and systems planning

e. General pharmacy management procedures for receiving, storing and dispensing investigational agents

f. Clinical and laboratory quality monitoring procedures

g. General procedures for preventing, identifying, handling, reporting and resolving protocol deviations

h. Quality control plans and procedures

i. Demonstration for independence of oversight including quality assurance procedures

j. Protocols for protection of Contributors’ intellectual property and data procedures

k. Archival plans for securing completed trial data according to regulatory requirements

l. Contingency planning

m. Training: For human subject protection (HSP) or current Good Clinical Practices

(cGCP), plan for training of technical staff, clinicians and/or scientists designated by the Contractor on techniques, methods, and best practices relevant to the conduct of clinical trials carried out under the IDIQ contract. Must also include any other relevant or mandatory trainings for the contract.

Base Requirement: “Protocol Development and Trial Preparation” This requirement includes activities up to trial initiation. Continuation of trial activities is covered by the “Clinical Trial Implementation” quantity option.

i. Conduct Teleconferences and Meetings. Set up meetings with all applicable participants. Prepare and share agendas and slides 24-48 hours prior to the meetings. Prepare minutes of all site visits and teleconferences/webinars for submission to the COR for review and approval within 5 business days after the meeting.

a. Task Order kick-off meeting to review the contract requirements, timelines, milestones, and deliverables; discuss plans and approaches and identify any anticipated difficulties in completing the contract requirements.

b. Ad hoc Site Visits: Host a one-day meeting as requested by COR and/or CO.

It is anticipated that this will occur no more than once or twice per trial.

c. Ad hoc teleconference as requested by the COR and/or CO

ii. Finalize a protocol and submit to NINDS and the Sponsor/Contributor for review and approval in compliance with the timelines specified within the task order. Provide all necessary documentation for the proposed clinical trial to the contributor required to secure the IND approval (e.g., Form FDA 1571, Form FDA 1572) and work with Contributors to submit documents for all requisite regulatory approvals (e.g., IRB and FDA submissions). Prepare the informed consent form (ICF), which contains appropriate reference to data collection for awarded task orders and all other protocol specific supporting documents (e.g., subject recruitment advertisements), and submit the final protocol, any protocol amendments, ICF and other documents to the institutional review board (IRB) for review and approval.

iii. Prepare protocol amendments and modifications as required:

a. Upon COR approval, the Contractor shall submit the amended protocol and

ICF to the lRB for review and approval

b. The Contractor shall provide the amended protocol to the COR and the

Contributor/Sponsor

c. Upon IRB approval, the amended protocol and revised ICF shall be archived in the master regulatory file

d. The PMP, case reports forms and other supporting documents will be modified to reflect the protocol amendments; and

e. If necessary, the PI or designee shall conduct a training session describing the protocol amendment and its impact on clinical trial procedures and assessments

iv. Throughout the process essential regulatory documents as specified in ICH guideline should be generated and stored in files/folders and be available for monitors and for use in the subsequent quantity option when executed. Essential regulatory documents may include but are not limited to signed IRB approved protocol, informed consent form and advertisement for subject recruitment; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae;

licenses for PI and sub-investigators; investigator’s brochure, normal laboratory ranges, laboratory certification, financial disclosure documents, conflict of interest declaration, indemnification/insurance documents, Form FDA 1571, Form FDA 1572.

These and all relevant data/documents must be maintained with compliance with all Information Technology preparedness, security, and compliance with contract requirements e.g., 508 of the Rehabilitation Act of 1973, as amended by the Workforce Investment Act of 1998.

v. Prepare and deliver a trial-specific Project Management Plan (PMP) within 60 calendar days after task order award and before dosing of the first subject. The PMP must be a single, well-organized document or folder that clearly connects document elements with the sections below. The PMP shall address and include, at a minimum, the following:

a. Clinical Quality Management Plan (CQMP): consisting of, at a minimum, the following: acceptance criteria for each deliverable, procedures and process controls for each deliverable, roles and responsibilities of personnel involved, and assurance that the established procedures and processes are followed.

Timelines must be included in the plan. Develop, maintain, update, and submit the CQMP to the COR for approval. Update the CQMP annually, or as specified by the COR. CQMP shall be contractor-specific as well as site-specific. Upon request of the COR/NINDS, provide summary statements about the contractor QC/QA findings that demonstrate utilization of the CQMP

b. Project-specific standard operating procedures (SOPs) for the conduct of Phase

I clinical trials and for all other integrated and collaborating services

c. Personnel listing including their roles and responsibilities to include an organizational chart

d. Human subject considerations (e.g., federal wide assurance (FWA), initial and continuing human subject training/education for personnel, data and safety monitoring plan, consenting procedures, procedures for managing medical emergencies on-site, reporting of adverse events (AEs), serious adverse events (SAEs), unexpected adverse events, hospitalizations, and procedures for prompt reporting of SAEs in compliance with FDA regulations and NIH policies)

e. Data Safety and Monitoring (DSM) plan including an Independent Safety Monitor in accordance with NIH guidelines and policies for DSM for review and approval by the IRB https://www.ninds.nih.gov/funding/apply-funding/application-support-library/clinical-research-guidelines/ninds-guidelines-monitoring-clinical-trials

f. Training program for clinicians, clinical site staff, data management staff and other support staff in the protocol procedures with every task order protocol in order to ensure reliability of evaluation, treatment, and assessment procedures

g. Recruitment and retention plan (e.g., enrollment of a diverse subject pool, including women and minorities, rate of subject accrual, subject retention, plans for deficient enrollment). Enrollment data shall be collected and reported according to current federal laws and policies.

h. Data management procedures and systems planning that is in compliance as specified with the contract terms and conditions including but not limited to development of database and case report forms (CRFs) using NINDS common data element where applicable https://www.commondataelements.ninds.nih.gov/#

i. Data collection, data monitoring, data safety review

j. Plan and timeline for development of the statistical analysis plan (SAP)

k. Pharmacy management procedures for receiving, storing and dispensing investigational agents; also, to be included a procedure for randomization and if appropriate stratification of eligible subjects

l. Bioanalytical method development plan https://www.ninds.nih.gov/funding/apply-funding/application-support-library/clinical-research-guidelines/ninds-guidelines-monitoring-clinical-trials https://www.ninds.nih.gov/funding/apply-funding/application-support-library/clinical-research-guidelines/ninds-guidelines-monitoring-clinical-trials https://www.ninds.nih.gov/funding/apply-funding/application-support-library/clinical-research-guidelines/ninds-guidelines-monitoring-clinical-trials https://www.commondataelements.ninds.nih.gov/

m. Blinding plan, including during pharmacy, clinical and data management activities, as appropriate

n. Clinical and laboratory quality monitoring procedures

o. Procedures for preventing, identifying, handling, reporting, and resolving protocol deviations

p. Quality control plans and procedures

q. Establishment and demonstration for independence of oversight including quality assurance procedures

r. Protection of Contributors’ intellectual property and data procedures

s. Archival plans for securing completed trial data according to regulatory requirements

t. Contingency planning

u. Plan for quality control and quality assurance, e.g., monitoring plans, data quality plans and audits; and

v. Training: For human subject protection (HSP) or current Good Clinical Practices (cGCP), develop, implement, and provide training to technical staff, clinicians and/or scientists designated by the Contractor on techniques, methods, and best practices relevant to the conduct of clinical trials carried out under the IDIQ contract. Maintain a log of the date and recipients for HSP and GCP training.

Prior to the training program’s execution, ensure the training program is consistent with HHS policy.

w. Close-out plan

vi. Regulatory preparations and compliance:

a. Register the clinical trial in the National Library of Medicine’s Clinical Trials registry (http://www.clinicaltrials.gov); Data will be shared according to federal laws and policies.

b. Ensure all requisite regulatory approvals are in place (e.g., IRB and FDA submissions) including that the investigational agent has appropriate FDA clearance (i.e., IND) confirming the agent’s suitability for testing in humans prior to initiating recruitment http://www.clinicaltrials.gov/

c. Obtain any necessary Material Transfer Agreement (MTA) from Contributor/Sponsor

d. Throughout the studies essential regulatory documents should be generated and stored in files/folders and be available for monitors and at the end of the studies all essential regulatory documents at the clinical research unit should be placed in the master regulatory file for archiving. Regulatory documents may include but are not limited to: IRB approved protocol, ICF and advertising; IRB approval letter; IRB membership list; PI and sub-investigators curriculum vitae; licenses for PI and sub-investigators; investigator’s brochure, normal laboratory ranges, laboratory certification, financial disclosure documents, indemnification/insurance documents, Form FDA 1572, investigational agent shipment receipts, etc. During the conduct of the clinical trial, all new relevant information/data must be appended to the essential documents as it becomes available

e. Ensure that the conduct of the clinical trials is performed in compliance with all FDA and ICH GCP regulations and guidelines

f. Prepare a complete clinical study report in submission ready format for FDA unless otherwise specified. Additionally, the IND report for annual filing requirements to the IND application, as needed

vii. Bioanalytical Development

Perform assay development, qualification, and validation concurrent with protocol development for bioanalytical evaluation of clinical samples to have bioanalytical assays ready prior to clinical protocol implementation.

a. Provide the bioanalytical assay validation plan to the COR and the

Sponsor/Contributor prior to initiating the clinical protocol.

b. Complete validation and provide to the COR and the Sponsor/Contributor the bioanalytical validation report. The report may be submitted in the bioanalytical laboratory’s standard format, as long as every item listed in the FDA Bioanalytical Method Validation guidance documents has been addressed, all described results are included with the report, all described statistical analyses have been conducted, and a summary table listing the pass or failure of each of the validation criteria is included.

c. For clinical trials, the validation report must be submitted, reviewed, and approved by NINDS prior to initiation of any clinical enrollment.

viii. Database Build

a. As required for the conduct of the trial specified in the Task Order, the Contractor shall develop and validate a database for the clinical trial

b. The Contractor shall provide any required licenses, software or dictionaries for the database

Quantity Option “Trial Implementation”

i. Conduct Teleconferences and Meetings for the following. Prepare minutes of all site visits and teleconferences/webinars and submit to the COR for review and approval within 5 business days of the meeting.

a. Clinical Trial Initiation meeting to review the trial protocol, timelines, milestones, and deliverables.

b. Ad hoc Site Visits: Host a one-day meeting as requested by COR and/or CO. It is anticipated that this will occur no more than once or twice per trial.

c. Ad hoc teleconference as requested by the COR and/or CO

A) Protocol Implementation: Compliance and Oversight The PMP developed in “Protocol Development and Trial Preparation” shall be followed and documents updated as needed. Regulatory compliances shall also be maintained and updated as needed following the preparations made in the “Protocol Development and Trial Preparation” period.

i. Clinical Trial Initiation The Contractor’s clinical trial team and support staff shall participate in a clinical trial initiation meeting at the Contractor’s clinical research facility. The Contractor shall provide an invitation to NINDS and the Contributor/Sponsor to participate in person or via video conferencing. Prepare and deliver a summary report of the initiation meeting to include but not be limited to the agenda and the list of participants

ii. Protocol Amendments as required:

a. Prepare all protocol amendments and modifications. Prepare all modifications to the PMP or other documents as a result of the amendments.

b. Upon COR approval, the Contractor shall submit the amended protocol and

ICF to the lRB for review and approval

c. The Contractor shall provide the amended protocol to the COR and the

Contributor/Sponsor

d. Upon IRB approval, the amended protocol and revised ICF shall be archived in the master regulatory file

e. The PMP, case reports forms and other supporting documents will be modified to reflect the protocol amendments; and

f. If necessary, the PI or designee shall conduct a training session describing the protocol amendment and its impact on clinical trial procedures and assessments

iii. Protocol and trial-site Oversight:

a. Oversee and ensure adherence to the protocol all clinical activities conducted at the clinical research facility and all collaborating sites including research pharmacy, clinical laboratory, data management center, imaging center and subcontracting sites; and

b. Ensure that each participant: meets protocol entry criteria; has given informed consent and has undergone all the screening and baseline assessments as specified in the protocol

c. Develop and implement remedial/corrective actions to address site performance problems and issues identified through the clinical-site monitoring process.

iv. For each Task Order protocol:

a. Track subject enrollment and adherence to defined recruitment goals

b. Review and assess participant data as specified within the data management plan, protocol requirements and/or quality assurance requirements. For example:

i. Promptly provide all data reports for monitor review prior to start of dose escalation decisions

ii. Monitor continuously for the validity and integrity of the accumulating data

iii. Monitor continuously protocol adherence and compliance with current ICH GCP guidelines, DHHS Protection of Human Subjects regulations (45 CFR Part 46) and FDA regulations and report all protocol deviations

iv. Report of any serious adverse events and/or unexpected adverse events to FDA, IRB, and COR

v. Report all performance-related issues and proposed resolutions or corrective actions taken; and

vi. Database summary tables for monitoring and tracking purposes throughout the course of the clinical trial including subject enrollment updates

c. Update clinicaltrials.gov as required by NIH policy and Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801)

v. Data Management and Quality Control:

a. Maintain and update the clinical database throughout the trial

b. Modify the database to support any protocol amendments that are implemented during the conduct of the clinical trial, as required; and

c. Provide quality control to ensure initial data entry within 24 hours and to correct or issue a data query within 48 hours and inform promptly the clinical research staff of any missing, incomplete, and erroneous data

vi. Audit Compliance The NINDS at their discretion may undertake an audit of the Contractor’s facility including all collaborating sites. The Contractor shall make available all facilities, records and files related to any activity under the contract. The Contractor shall submit a report describing the implementation of the corrective actions.

B) Investigational Agents and Clinical Specimens

i. Investigational Agent:

a. Maintain inventory records of investigational agent in accordance with the pharmacy SOPs

b. Maintain documentation that the investigational agent will be stored and quarantined under appropriate conditions in the research pharmacy according to the sponsor and regulatory requirements; and

c. Mechanism for the return and/or destruction of investigational material

ii. Clinical Specimens

a. Ensure collection, processing, labeling, temporary storage under appropriate conditions and management of all collected biological specimens

b. Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current Good Laboratory Practice (cGLP), cGCP and domestic laws and regulations.

Maintain clear chain of custody; ensure reporting of deviations and sample labeling issues.

c. Conduct protocol-required testing (including but not limited to screening, safety, and human anti-human (HAHA) laboratory testing); and

d. Maintain current Clinical Laboratory Improvement Amendment certification (http://www.cms.gov/clia/ and The Joint Commission approval (http://www.jointcommission.org/)) or local equivalent, as appropriate

C) Clinical Trial Analysis, Close-out, and Final Clinical Trial Reporting

i. Close-out and Analysis

Following the last subject’s completion of clinical trial procedures including any outpatient follow- up visits, the Contractor shall:

a. Continue to monitor any residual safety concerns (i.e., AEs & SAEs) until complete resolution

b. Complete data editing/cleanup

c. Finalize and lock the database

d. Conduct the statistical analysis as described in the PMP http://www.cms.gov/clia/ http://www.jointcommission.org/

e. Deliver the locked deidentified database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR;

f. Provide to the COR with the final enrollment report according to current federal laws and policies

g. Provide annual IND reports to the FDA and the COR within 60 days of the anniversary date the IND went into effect for as long as the IND remains open, or as recommended by current FDA guidance; and

h. Register trial results in clinicaltrials.gov within 3 months of the trial completion date unless otherwise directed by the COR

ii. Completion:

a. Prepare for archiving the final dataset and all associated clinical trial records.

Clinical trial records are considered case report forms and detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary);

b. Prepare and deliver draft and final clinical study report; the study report must be in a format suitable for submission to the FDA; and

c. Archive the final locked dataset with de-identified data for each clinical trial conducted under each task order in an agreed upon format (e.g., R, SAS, SPSS, ASCII) that is readily usable by NINDS, Contributor/Sponsor or NINDS designee.

D) Facilities, Equipment and Other Resources The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of a clinical trial which may include but is not limited to the following.

i. Provide Inpatient Clinical Research Facility:

a. Accreditation with a national or state accreditation board for the conduct of clinical trials

b. Areas to allow for waiting, check-in and discharge

c. Examination rooms to allow for protocol-related assessments

d. Standard clinical support services for inpatient care, twenty-four hours/day, seven days/week

e. Capability to recruit healthy volunteers and target populations

f. Adequate and secure computing resources for communication and data management (e.g., entry editing, quality control)

g. Adequate and secure electronic access to the data management center

h. Emergency care and a definitive plan for management of life-threatening adverse events including on-site resuscitation equipment and hospitalization procedures in the event a participant requires these services

i. Adequate equipment, staff, and services for performing routine safety evaluations (e.g., vital signs, ECG), precisely timed phlebotomy, collection of cerebrospinal fluid (CSF), urine and other bodily fluids for PK/PD trials and processing of PK and PD samples

j. Capabilities for the collection of cerebrospinal fluid (CSF) via lumbar puncture or with a temporary in-dwelling catheter if required by the TOFRP

k. Ability to provide experienced research staff to perform cognitive testing, using paper or computer-based systems

l. Staff with expertise in the conduct of Phase I clinical trials including but not limited to physicians, pharmacologists, clinical specialists, registered research nurses, study coordinators, clinical research associates, research assistants, Independent Safety Monitor(s) (ISM) and research pharmacists

m. Access to clinical specialists in the therapeutic areas covered by NINDS, the NIH Blueprint Neurotherapeutics Network and NIH HEAL Initiatives for additional safety assessments that may be required in select clinical trials, such as ophthalmology exam or detailed neurologic examination; and

n. Pharmacovigilance capabilities for composition of serious adverse event reports and narratives

ii. Provide cGLP Clinical Laboratory Facility:

a. Adequate space for the processing and temporary storage of biological specimens

b. Adequate facilities and equipment for conducting protocol-required tests and assays such as PK and specialty PD assays on blood, plasma, CSF or other body fluids and tissues

c. On-site sample storage facilities at room temperature, 4, -20 and -80 degrees Celsius

d. Clinical laboratory support services with provisions of 24 hours/day testing if required by the protocol

e. Adequate and secure electronic access to the data management center; and

f. Have current certification and licensure for the performance of biological specimen assays and analyses

iii. Provide Research Laboratory Facility:

a. Adequate space and equipment for the processing, temporary storage, and shipment of biological specimens

b. Adequate facilities and equipment for conducting protocol-required tests and assays such as PK and specialty PD assays on blood, plasma, CSF or other body fluids and tissues

c. Capabilities to design and validate PK,PD and biomarker assays

d. On-site sample storage facilities at room temperature, 4, -20 and -80 degrees

Celsius

e. Adequate and secure electronic access to the data management center; and

f. Have current certification and licensure for the performance of biological specimen assays and analyses

iv. Provide Clinical Imaging Facility:

a. Adequate and secure electronic access to the data management center

b. Adequate facilities and equipment for conducting protocol-required imaging procedures for diagnosis or special safety evaluations, including echocardiogram, computerized tomography (CT), magnetic resonance imaging (MRI), proton emission tomography (PET), electromyography (EMG), and electroencephalography (EEG)

c. Electroretinography (ERG); and

d. Have current certifications and licensures for the performance of imaging procedures

v. Provide Research Pharmacy Facility:

a. Research pharmacist with expertise in the preparation, distribution, and storage of investigational agents for Phase I clinical trials

b. Limited cGMP capability for compounding and manipulations such as over encapsulation

c. Adequate space for processing, storing, and dispensing investigational agents under appropriate conditions

d. Adequate and secure electronic access to the data management center; and

e. Have current accreditation and certification for the performance of pharmacy services

vi. Provide Data Management Center:

a. Adequate computing resources to support data collection activities

b. Personnel knowledgeable about data management activities and operations but not limited to data management planning and reporting, performance reporting, quality assurance and administrative support

c. Clinical data warehousing capabilities/facilities in order to provide a centralized, integrated system for data storage, analysis, reporting and ad hoc query of clinical data

d. Data management capabilities necessary to support the conduct of Phase I clinical trials, such as case report form (CRF) design, data dictionary development, database programming, data base design and development in compliance with Good Clinical Practice (GCP) guidelines and Clinical Data Interchange Standards Consortium (CDISC)

e. Provide other facilities and equipment, as may be specified by the task order protocols (e.g., biosafety laboratory facilities in compliance with Federal and state regulations); and

f. Personnel knowledgeable about data security

The NINDS anticipates awarding multiple Indefinite Delivery Indefinite Quantity (IDIQ) type contracts under this program with a ten-year ordering period to allow for the issuance of fixed-price or completion type cost-reimbursement task orders. It is also anticipated that the IDIQ awards will be made in the second quarter of Fiscal Year 2025.

Offerors are required to be registered and active in the System for Award Management (SAM) when submitting a proposal and shall continue to be registered until time of award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from a solicitation.

Processing time should be taken into consideration when registering. Offerors who are not registered in SAM should consider applying for registration immediately upon receipt of this pre-solicitation. See FAR 52.204-7 System for Award Management (Oct 2018) and https://www.sam.gov for information on registration.

This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No.

75N95024R00086 will be available electronically and may be accessed through the SAM (URL: https://www.sam.gov) 30 or more calendar days after the issuance of this synopsis.

THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE

RESPONSIBLE FOR ROUTINELY CHECKING THE SAM WEBSITE FOR ANY POSSIBLE

SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF

ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.

https://www.sam.gov/ https://www.sam.gov/