Clinical Research Services for a Multi-Country Phase III Contraceptive Trial

Location:	District of Columbia
Posted:	Feb 9, 2026
Due:	Feb 17, 2026
Agency:	FHI 360
Type of Government:	State & Local
Category:	A - Research and development
Solicitation No:	103481.02_RFP_02
Publication URL:	To access bid details, please log in.

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REQUEST FOR PROPOSAL (RFP)

Solicitation title:

Term of Contract:

This Procurement supports:

Submit Proposal to:

Date of Issue of RFP:

Date Questions Due:

Date Proposal Due:

Approximate Date Contract Issued:

Format of Submission:

Clinical Research Services for a Multi-Country Phase III Contraceptive Trial

~5 years

Phase III Contraceptive Clinical Trial

Christina Vernon, cvernon@fhi360.org

January 28, 2026

February 6, 2026

February 17, 2026

August 2026

Respond via e-mail with attached document in MS Word/Excel/pdf

format. The Offeror agrees to hold the prices in its proposal firm for 120

days from the date specified for the receipt of proposals, unless another

time is specified in the addendum of the RFP.

BACKGROUND:

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by

advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition,

environment, economic development, civil society, gender, youth, research, technology,

communication, and social marketing—creating a unique mix of capabilities to address today’s

interrelated development challenges. FHI 360 serves more than 70 countries and all U.S. states and

territories.

FHI 360’s Contraceptive Research, Development, and Introduction (CRDI) department strives to

accelerate wide access to quality, affordable and acceptable contraceptive products for those most in

need. In support of this goal, we are planning to conduct an open-label multi-country phase III

contraceptive clinical trial with a total enrollment target of 1,700 participants. We anticipate that

screening will begin in February 2028 and participants will be on study for 12 months. We are seeking a

contract research organization (CRO) to support us in three main ways (1) evaluate and identify sites to

participate in the Phase 3 study, (2) provide full CRO support services for the Phase 3 study, and (3)

perform various inspection readiness and regulatory submission activities.

Please respond to some or all activities within the Statement of Work. Additionally provide a budget file

with the estimate broken down by 12-month periods starting in August 2026 (e.g., total cost estimate by

year). Year 1 would cover the first 12 months (~August 2026 through July 2027) and include evaluating

and identifying sites to participate in the Phase 3 clinical trial and a portion of Phase 3 clinical trial

preparation activities.

If applicable, prior to sharing any confidential documents including the Phase 3 study protocol synopsis,

FHI 360 will ensure a confidentiality agreement is fully executed, using FHI 360’s template, with

potential CROs.

II. SCOPE OF WORK

It is anticipated that the selected Offeror will perform the following:

Site Identification and Feasibility

• Utilize databases or other intelligence tools to conduct site identification

• Develop study-specific site questionnaires

• Coordinate study-specific site discussions, highlighting risk areas identified during feasibility

assessments

• Interview potential sites to assess infrastructure, patient population dynamics, therapeutic areas of

expertise, investigator qualifications bandwidth and interests, recruitment history, strategies and

capacity, and ability to comply with FHI 360, regulatory authority, Good Clinical Practice, and

institutional requirements

• Provide written recommendations to FHI 360 of best sites and number of sites including rationale

and detailed findings of site assessments, forecast of recruitment potential based on study design

and eligibility criteria, and including foreseeable limitations/challenges of the proposed sites

• NOTE: This activity may include in person site visits

Regulatory

• Obtain and maintain competent authority (CA) and ethic committee(s) (EC) approvals in select

countries:

▪ Preparation, assembly, publishing, and electronic submission of each component of the

Clinical Trial Application (CTA) submission

▪ Development/updates of the Investigator’s Brochure (IB) as part of CTA submission

▪ Preparation and submission to ECs and/or assistance to investigators

▪ Assist with review and response to any CA/EC information requests

▪ Annual renewal, maintenance, and update of CA/EC approvals (e.g., annual progress

reporting; writing and publishing of Development Safety Update Reports (DSURs))

▪ Safety report submissions

▪ End-of-study notifications

• Provide regulatory project management support through life of project

• Manage trial registration (e.g., required national registries, clinicaltrials.gov and/or ISRCTN)

Safety Management, Medical Monitoring, and Data and Safety Monitoring Board (DSMB)

• Provide input on the protocol’s design and create the medical monitoring plan

• Monitor the progress of the trial and clinical and safety data ensuring that the trial is conducted

according to the protocol and identifying any patterns of medical or safety issues

• Review concomitant medication and adverse event coding

• Review safety data for final analysis for accuracy

• Manage, facilitate, and coordinate DSMB

• Develop and maintain safety database (e.g., Argus)

• Perform pharmacovigilance case management of Serious Adverse Events (SAEs)

• Triage and review SAEs

• Develop SAE narratives

• Perform medical coding of SAEs using MedDRA

• Coordinate SAE query resolution and follow-up

• Conduct medical review of SAEs

• Develop a Safety/SAE Management Plan (SMP)

• Generate SAE line listings from safety database for routine reconciliations

• Coordinate and submit Suspected Unexpected Serious Adverse Reactions (SUSAR) and other

reportable safety event reports to applicable regulatory authority

Investigational Medicinal Product (IMP) and Clinical Trial Materials (CTM) coordination

• Manage IMP shipment logistics from origination through clinical site distribution

• Provide guidance on import/export country requirements for IMP

• Obtain all required import/export licenses

• Provide guidance and coordinate customs clearance procedures with clinical sites, as required by

local law

• Guide IMP labeling requirements and provide translation assistance, if needed

• Obtain qualified person (QP) certification, if required

Clinical Monitoring

• Develop and maintain clinical monitoring plan

• Conduct or participate in site qualification/evaluation, site initiation training, interim monitoring

and closeout visits

• Conduct all clinical monitoring activities as described in the clinical monitoring plan

• Complete visit reports and submit as required by timeline in the clinical monitoring plan

• Conduct ongoing training of clinical site staff for the duration of the clinical trial as directed by FHI

360

• Maintain active communication with clinical sites between visits to address action items and

issues

• Complete study-specific, Electronic Data Capture (EDC), Standard Operating Procedures (SOPs),

Good Clinical Practice (GCP), and research ethics training

Data Management, Programming, Biostatistics

• Develop and design the study-specific Data Management Plan, Clinical Data Interchange Standards

Consortium (CDISC)/Clinical Data Acquisition Standards Harmonization (CDASH)-compliant

electronic case report forms (eCRFs) eCRFs and eCRF completion guidelines

• Set up and maintain the EDC

• Validate project-specific components of the EDC

• Provide database training and access to medical monitors, Clinical Research Associates (CRAs),

clinical site, and project managers

• Review clinical data for errors and patterns and generate electronic queries

• Set up and maintain EDC

• Manage interim and final analysis timelines and processes for data coding, cleaning, query

resolution, source data verification (SDV) confirmation

• Provide Study Data Tabulation Model (SDTM) specifications and clean, analyzable SDTM data to

FHI 360 for review prior to planned interim and final analyses following CDISC standards

• Perform routine reconciliations between clinical and safety databases

• Provide routine site-level and study-level data metric reports to FHI 360

• Deliver comprehensive data reports and data exports capabilities to enable real-time decision

making

• Establish auto-alerts for select data entry items (e.g., SAEs, deviations, pregnancies)

• Identify patterns of delayed data entry, data entry errors, and queries and notify sites and FHI 360

to any issues identified

• Attend monthly routine meetings with FHI 360 and CRAs to discuss data-related issues

• Develop visit scheduling tool/software program for site to use for scheduling and tracking

participant visits and train site on tool

• Perform database lock and post-lock data transfer and archival

• Provide final completed CRFs to each site at end of study

• Perform external data import and reconciliations (e.g., safety database, central lab data)

• Manage data-related issues at sites and maintain frequent and ongoing communication with the

sites

• Provide medical coding using standardized dictionary (e.g., MedDRA)

• Provide ongoing centralized statistical monitoring

• Review/provide input to draft Statistical Analysis Plan (SAP) before being finalized by sponsor

• Draft table shells based on SAP provided by sponsor

• Finalize table shells with 2 rounds of review with sponsor

• Draft Figure shells based on SAP provided by sponsor

• Finalize Figure shells with 2 rounds of review with sponsor

• Generate draft results based on Tables and Figures

• Finalize analysis with 2 rounds of sponsor review (allow for up to 5 additional Tables and 3 Figures

based on this stage of review)

• Support writing the Clinical Study Report

Site Management

• Manage contract, budget, and receiving and processing of invoices

• Assist with document translation and submission to IRBs/EC and in country regulatory agencies

Recruitment

• Conduct and adjust recruitment methods based on data-driven forecasting, site-specific

considerations, and ongoing recruitment performance at individual sites and across sites

• Track recruitment and provide recruitment metrics to FHI 360 with recommendations for strategy

shifts

• Identify, manage and train project staff on site-appropriate recruitment and pre-screening tools

that may include social media campaigns, flyers, radio/TV advertisements, pre-screening

questionnaires and community outreach activities

• In close collaboration with sites, develop customized recruitment plans

Medical Writing

• Write essential study documents including Phase 3 clinical trial protocol and amendment(s),

Investigator’s Brochure (IB) updates, and clinical study report, incorporating contributions form

study team members and subject matter experts (SMEs)

• Write informed consent form(s), study manual (if needed), pharmacy/Investigational Medicinal

Product (IMP) manual, risk management plan, medical monitoring plan, and clinical monitoring

plan

• Coordinate, schedule, and facilitate comment resolution meetings and address and incorporate

comments from study team members/SMEs

• Manage the document development process by creating timelines and coordinating reviews,

quality control, quality assurance, and approval of documents

Quality Assurance

• Develop Critical to Quality (CtQ) register; Risk Assessment and QRMP; QTL/acceptable‑range

rationale & thresholds; Corrective and Preventive Action (CAPA) trackers

• Conduct routine and risk-based GCP audits at each clinical study site and of electronic Trial Master

File (eTMF)

• Advise FHI 360 and sites on gaps and study compliance to regulatory authority requirements

Inspection readiness activities

• Develop a detailed inspection readiness plan describing the strategy, timeline and roles and

responsibilities associated with mock inspection activities

• Conduct mock inspections of:

▪ Phase 3 clinical trial sites, including local diagnostic laboratories

▪ Sponsor (located in USA)

▪ Central PK laboratory (located in USA)

▪ Vendors supporting the Phase 3 trial

▪ Clinical supplies logistics vendor

▪ Manufacturer (located in USA)

• Verify adherence to GxP

• Train study sponsor, site and vendor staff to manage stringent regulatory inspections

• Coordinate discussions highlighting GCP compliance risks/areas for improvement identified during

assessments

• Complete mock inspection reports that provide detailed findings of the mock inspections and

corrective action plans; guide staff on adequacy of responses and corrective actions

• Maintain active communication with inspectees to address action items and issues

• Provide onsite Quality Assurance (QA) lead to support actual European Medicines Agency

(EMA)/World Health Organization (WHO) inspections as needed

• Assist in drafting corrective actions for actual EMA/WHO inspection findings

EMA submission activities

• Provide regulatory strategy and management support for EMA submission

• Support pre-submission and submission activities, agency communications and meetings

• Develop risk management plan, pharmacovigilance system master file and prepare for post-

opinion safety monitoring

• Develop the regulatory dossier in a standard 5-module eCTD format:

▪ Draft Modules 1 and 3

▪ Review and input on Modules 2, 4 and 5

• Prepare, assemble, publish, and electronic submission of each component of the EMA submission

III. OFFEROR QUALIFICATIONS

To be considered for this award, the Offeror must have:

• Experience managing large global complex clinical trials

This is the opportunity summary page. It provides an overview of this opportunity and a preview of the attached documentation.

Clinical Research Services for a Multi-Country Phase III Contraceptive Trial

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See also