How we work, and what we deliver.
Eight services across two tracks, with engagement models and price ranges that reflect the realities of working with both small research sites and global pharmaceutical sponsors. Every engagement starts with a 30-minute exploratory call to confirm fit.
01
TRACK 01 • FOR U.S. RESEARCH SITES
Performing better and being trusted with more.
Independent and academic research sites win and keep sponsor business by being predictable: enrolling on time, passing monitor visits cleanly, and responding fast to regulatory queries. We help sites get there with the workflow, regulatory, and recruitment systems that good performance actually requires.
SERVICE 01
Research site optimization
Fixed-fee project (scoped per site context)
A focused diagnostic and rebuild of the operational systems that determine whether your site enrolls on schedule and passes monitor visits cleanly. We assess current workflows, identify the highest-leverage gaps, and leave you with implementable playbooks.
Deliverables:
Recruitment workflow playbook, AE/SAE tracking system, Monitor readiness checklist, Source documentation review
Best for: Independent and academic sites running 3+ concurrent trials. Typical engagement: 4-8 weeks.
SERVICE 02
Regulatory document support
Hourly or short-term retainer (scoped per submission)
Hands-on support for the regulatory documents that determine activation speed and ongoing compliance. We work as an extension of your team, on the schedule the protocol demands.
What’s included:
IRB-ready submissions, Site qualification packages, Sponsor questionnaire response
Best for: Sites without dedicated regulatory staff, or with surge needs around new study activation.
SERVICE 03
Recruitment strategy
Fixed-fee project (scoped per protocol)
A protocol-specific recruitment plan that combines community engagement, referral pathways, and digital outreach. Includes a deliverable plan with channels, messaging, timelines, and a measurement framework.
Deliverables:
Recruitment plan document, Community engagement playbook, Digital & referral channel design
Best for: Sites with a specific protocol facing enrollment risk, or sites building a repeatable recruitment system across studies.
SERVICE 04
Fractional regulatory specialist
Monthly retainer (8-15 hours/month)
Ongoing regulatory support for sites that need professional regulatory capacity but don't have the trial volume to justify a full-time hire.
What’s included:
Regulatory file maintenance, Submissions & amendments, Sponsor & monitor liaison
Best for: Smaller sites running 1-3 trials concurrently. 6-month minimum engagement.
02
TRACK 02 • FOR WEST AFRICA TRIAL EXPANSION
Bringing trials to Nigeria, done right.
Most sponsors evaluating West African expansion either rely on generic emerging-market frameworks or skip the continent entirely. We work with sponsors and CROs through the specific operational, regulatory, and ethical decisions that determine whether a Nigerian trial succeeds or becomes a cautionary tale.
SERVICE 05
Site feasibility & landscape assessment
Fixed-fee project (scoped per protocol)
A 4-6 week assessment that answers: can this protocol run successfully in Nigeria, where, and what are the realistic timelines and risks? Designed to feed directly into sponsor go/no-go decisions before significant capital is committed.
Deliverables:
Therapeutic-area landscape report, 6- 12 candidate site profiles, Regulatory pathway memo, Protocol-specific risk register
Best for: Sponsors evaluating Nigerian inclusion in a phase 2 or 3 program. Typical engagement: 4-6 weeks.
SERVICE 06
Regulatory submission support
Hourly or monthly retainer (scoped per submission)
End-to-end support for NAFDAC Clinical Trial Applications and parallel ethics submissions. Covers package preparation, query response, and ongoing maintenance through trial activation.
What’s included:
NAFDAC-ready CTA package, NHREC & site IRB submissions, IP import licensing support, and ongoing query response
Best for: Sponsors who have selected Nigerian sites and need regulatory submission expertise. Often follows a feasibility assessment.
SERVICE 07
Site activation & recruitment strategy
Project or retainer (scoped per program)
We work alongside selected Nigerian sites to translate sponsor protocols into locally-executable recruitment plans — accounting for community engagement, ethical consent processes, and the operational realities that determine enrollment success.
Deliverables:
Locally-grounded recruitment plan, Community engagement protocol, Consent process review
Best for: Sponsors moving from feasibility to activation. Coordination throughout the study startup.
SERVICE 08
Strategic advisory
Quarterly retainer (established clients only)
For sponsors making longer-term commitments to African research. Quarterly engagements covering benefit-sharing structures, post-trial access strategy, partnership scouting with academic institutions, and trial design adjustments that improve regulatory acceptance.
Scope of work:
Benefit-sharing structures, Post-trial access strategy, Partnership scouting
Best for: Sponsors building a multi-year African research strategy. Reserved for established client relationships.
How we engage
Every engagement, regardless of track, follows the same four-step process. Pricing and scope are confirmed in writing before either side commits.
STEP 01
Exploratory call
30 minutes. We learn what you're working on; you learn whether we're the right fit. No pressure, no slides.
STEP 02
Scoping memo
Within a week of the call, you receive a 1-2-page memo outlining the proposed scope, deliverables, timeline, and pricing fixed-fee or hourly, as appropriate.
STEP 03
Engagement letter & kickoff
Once aligned, we sign a brief engagement letter and start work typically within 5 business days of agreement
STEP 04
Delivery & next steps
We deliver against the scope, present findings, and discuss whether further engagement makes sense. No retainers without a reason.
Common questions
How is pricing determined?
Every engagement is scoped to the specifics of your protocol, site, or program. After our exploratory call, we send a written scoping memo with fixed-fee pricing for project work or hourly/retainer rates for ongoing support. We do not negotiate over scope; we agree on it before we start, in writing.
What's the smallest engagement you take?
For U.S. site work, hourly engagements can start as small as 10-15 hours when the scope is well-defined. For West Africa work, the smallest meaningful engagement is a feasibility assessment; anything less doesn't produce a deliverable that a sponsor can actually use.
Do you sign confidentiality and conflict-of-interest agreements?
Yes. Mutual NDAs and conflict checks are standard at the scoping stage, before any protocol or asset details are shared. Our engagement letter template includes confidentiality, IP, and conflict provisions calibrated to pharma standards.
Have you actually run trials in Nigeria?
Not yet. Our hands-on trial experience is U.S.-based. The value we bring to West African expansion is the combination of U.S. operational rigor, Nigerian cultural fluency, and a research-ethics-first orientation, not a track record of running trials on the continent. We are honest about this with every prospective client. (See our About page for more.)
Can you work with our existing CRO partner?
Often, yes. We are not a CRO and do not compete with one. We typically work alongside existing CRO partners on Nigeria-specific scopes that they don't have internal expertise for, or directly with sponsors before a CRO has been selected.
How quickly can you start?
From exploratory call to scoping memo: roughly one week. From engagement letter to kickoff: typically 5 business days. We are deliberately small and only work on a limited number of engagements at a time, so capacity availability is honest and confirmed at the scoping stage, not promised then walked back.
Talk through what you're working on.
Every engagement starts with a 30-minute exploratory call. No slides, no pitch, just a conversation about whether this is the right fit.
or email info@horizonclinicalnexus.com