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

Location:	District of Columbia
Posted:	Feb 12, 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 Proposals

Modification 2

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

Solicitation No. 103481.02_RFP_02

Date of Modification: February 12, 2026

This solicitation is modified as follows:

1) Q&A for inquiries received (to date) in relation to the RFP are included in the page(s) below.

All other terms of the RFP remain unchanged and in full force and effect.

[End of Modification 2]

1. Are any preferred geographies or anticipated site ranges we should factor in? We expect this

trial to be conducted across geographic regions (e.g., Africa, Asia, Europe and Latin America);

however, final sites will be selected based on the site identification and feasibility component of

the project. Due to anticipated enrollment difficulties, we are not looking at sites in the United

States. Countries of particular interest due to past work include South Africa, Ghana, Uganda,

Kenya, Brazil, and Thailand. However, we will consider the most feasible sites and will plan to

utilize at least one European site. Please note that we need 25% participants to be enrolled in

the EU, and our funder is also interested in an Indian site participating in this trial. We’d like

geographic diversity but are open to multiple sites in the same country to ease regulatory

burdens.

2. Who will be involved in the CRO selection process? FHI 360 Project Manager, Clinical Trial

Manager, Director of Clinical Operations, and Director of Regulatory Affairs.

3. Is the project currently funded, and if so, are you able to share the planned funding source? The

particular work in the SOW is not yet funded. We are not disclosing the funder at this time, but

it is not USG funded.

4. Can you confirm any previous / historic vendor preference and if FHI has specific CTMS, Lab or

other preferences. For Clinical Trial Management System, we don’t have a preference since we

don’t have one ourselves, and we prefer Medidata Rave or something similar for an electronic

data capture system.

5. For regulatory, is the CRO expected to provide global regulatory support or EU regulatory

support only? We expect that the CRO will provide global regulatory support (please see

Regulatory section in the scope of work located in the RFP).

6. Approximately how many sites does FHI anticipate will be utilized? We’d like to complete

enrollment within one year, and we’d like the CRO’s guidance on number of sites based on the

feasibility and site ID analysis.

7. Does FHI have an approximate patient recruitment rate that they anticipate for this study? We

do not; however, we would like to complete enrollment within one year after first patient in.

8. Would FHI like the CRO to identify/contract with the central lab/PK lab or will this be done by

FHI? Central lab selection will be done by FHI 360. To note, we assume no PK assessments will

be done during the Ph 3 trial at this time.

9. Timeline: Are there any set timelines/milestones that the sponsor wants the CRO to meet?

o Target CRO Start Date ~August 2026

o FPI - ~March 2028

o Interim Analysis - ? Occur after ~6,750 primary evaluable cycles have been obtained

o LPI - One year after FPI (~March 2029)

o DB Lock - ? ~July 2030

10. The protocol synopsis mentions an adjudication committee in addition to the DSMB. Will the

CRO be responsible for managing both? Yes. The CRO will manage the DSMB and the pregnancy

adjudication committee.

11. Is there a limit on patients per country? E.g. No country would recruit more than 500 patients?

We do not have particular limits per country; however, 25% of participants will need to be

enrolled in the EU.

12. Patient Diary would be needed for the study – We will plan eDiary for the same. Hope that

would be fine. We prefer and eDiary but understand that some sites may need to use paper

diaries.

13. In case of Pregnancy – Please let us know if you plan to cover the cost till full term follow-up. It

may be needed by Regulators/ECs. We believe this may depend on regulatory/EC requirements.

14. Within Gynaecology Examination we assume transvaginal ultrasound (TVUS) would be needed

and the cost for same needs to be factored in. A TVUS will not be needed for the gynaecology

exam; however, a TVUS will be used in the trial, if needed, for a pregnancy diagnosis.

15. Among the services needed – we will mention the service we may not be equipped to perform –

e.g. Inspection Readiness Activities. Or is It mandatory that CRO perform all the activities?

Please let us know. It is not mandatory that the CRO perform all the activities. If this is the case,

please let us know which services you will not cover stated in the scope of work.

16. The RFP states a Word proposal is needed for submission. Are CROs able to provide a

PowerPoint proposal instead of Word, and RFP response? PowerPoint is fine.

17. Please clarify expected screening goal of Feb2028? With CRO start in Aug2026, screening could

begin earlier. Is there a reason for delaying screening until 2028 (i.e. drug availability)? We are

currently implementing a Phase 1 trial, and the last participant out is expected for April 2027.

After that, we will need to do final analysis and then we plan for an EMA Advice Meeting and

CTA submission. We believe that screening for the Phase 3 trial starting in February 2028 is the

soonest timepoint we can begin screening given what needs to occur prior to screening.

18. Does FHI360 have a corporate goal for last patient enrolled? 1 year of recruitment.

19. Should CRO include remote or in-person Investigator Meeting? If different regions, should we

include an IM per region? Or just one? One in person; depending on the other sites we can

consider remote.

20. Who will be responsible for the preparation of Development Safety Update Report (DSUR)?

CRO.

21. CRO has in-house label application ability. Should we include pricing to label the drug? If so,

please provide an assumption per patient. Yes, please include pricing to label the drug. We

estimate 72 pills per participant.

22. Should we include the development of Master and Country IMP Label? Yes.

23. When will the IMP be available to be shipped to sites? Q4 2027.

24. The study synopsis mentions the pregnancy adjudication committee, however this isn't listed as

in-scope services in the RFP. Please confirm if this needs to be scoped. If yes, please provide

below. Yes.

25. Estimated number of events to be adjudicated. We assume ~50 events.

26. Will CRO be responsible for charter development, member management including selection,

contracting and payments etc..? Yes.

27. What is the final protocol availability date or internal goal date for protocol completion? We’d

like a final draft ~July 2027 in preparation for a regulatory advice meeting prior to he Phase 3

trial.

28. Conducting blinded outreach to potential sites provides additional insight into interest, potential

challenges, and enrollment expectations for a POCP trial. Would FHI 360 permit us to conduct

blinded outreach with this aim? Yes.

29. We note the plan to have a subset of 100 participants 36-45 years of age enrolled at selected

sites. Are we correct in understanding that there will be a cap of patients within this age range

(e.g., no more than 100 patients enrolled)? Yes. This will be capped at 100 participants.

30. We also note that approximately 380 participants (20-25%) will be of Class I+ obesity (BMI ≥ 30

kg/m2). Will enrollment of this subset also be capped or is this intended to be a minimum

required? Yes. This will be capped at 20-25%.

31. A PK lab located in the USA is mentioned in the RFP; however, no PK assessments are noted in

the synopsis. Is the intent to have PK blood collected? If so, does FHI 360 need us to include

budget to support the PK biostatical analysis? Thank you. This was an oversight in the SOW. We

assume no PK assessments at this time for the Ph 3 trial.

32. 9The Trial Procedures and Assessments table notes a diary being utilized. Could you please

provide more detail on the data intended to be captured in this diary (i.e., is it solely

administration of study drug)? We also will collect bleeding and number of times a participant

has sex during the study.

33. Will safety labs be analyzed centrally? If so, should we include costing for central lab services? In

our past clinical trials, we’ve typically had safety labs done locally.

34. Is FHI 360 open to media-assisted recruitment approaches? Yes.

35. Is an IRT system required? Randomization is not required for the Phase 3 trial; however, this

may be helpful to track drug supply logistics. If the CRO recommends using this, include in the

proposal and budget.

36. What are the expectations for clinical supply management (import/export, depot use, QR

codes)? We expect the CRO to receive the study drug from a US based CDMO, label, and ship

product to all sites.

37. Are there cost constraints or resourcing expectations we should factor in? No.

38. Is a bid defense expected? Yes, most likely sometime in May or June 2026.

39. The protocol mentions a pregnancy adjudication committee to review accuracy of pregnancy

diagnosis and verify timing of pregnancy in relation to IMP use. If the CRO should include this

committee to the offer, would you like this committee to be set as an independent external

adjudication committee or would you prefer this committee to be an internal pregnancy review

committee that include study medical monitors? We prefer an internal adjudication committee

to include at least one member from the FHI 360 team.

40. Do you need your selected CRO to provide Legal Representation service in EU? We may need

Legal Representation in various countries depending on the location of the trial, so yes, we will

need the selected CRO to provide Legal Representation.

41. The RFP mentions Investigator Brochure (IB) update and Medical Writing (MW) tasks. Will these

tasks be needed at the start of the study, or later while the study is being conducted?

o If required during lead-in, please clarify the scope of the IB updates. We will get back

with a response early next week.

42. Will FHI 360 draft the EU IMPD themselves? The manufacturer is drafting the IMPD in

collaboration with FHI 360.

43. If not should the CRO plan to draft the IMPD? The CRO does not need to draft the IMPD.

44. Does FHI anticipate any scientific advice interactions in the EU or other regions prior to

study start? Yes. FHI 360 will participate in a pre-EMA Scientific Advice Meeting prior to

starting the Phase 3 trial.

45. What countries does FHI 360 plan to have the product approved in? Is approval in EU

planned? Other regions? The EU and non-US markets, particularly in low and middle-

income countries.

46. For EMA submission - is it planned as an EU-M4all submission or standard EU

centralized procedure? Currently EU centralized procedure, but we may seek eligibility

for EU-M4ALL in the future.

47. Should we indicate which services we will subcontract to a third party? Yes. Please

indicate which services you will subcontract for.

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 - POCP Ph 3 Study Solicitation Q&A Mod

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