Clinical Development

Planning a clinical study in Africa?

MedNova provides integrated clinical development services — from feasibility and regulatory planning through study close-out — to help sponsors execute with confidence across Nigeria and West Africa.

STUDY LIFECYCLE
1
Feasibility & ReadinessIs the site, region, and protocol a fit?
2
Regulatory & Start-UpRegulatory approval, ethics, site activation
3
Clinical OperationsMonitoring, recruitment, data
4
Close-OutDatabase lock, inspection-ready
● One team, every stage
Our Approach

Discovery through close-out, one workflow

Every engagement moves through the same sequence — visible to the sponsor at every stage.

1FeasibilityBefore day one
2Trial ReadinessBefore day one
3Regulatory ApprovalRegulatory & ethics
4Site ActivationStudy start-up
5Clinical OperationsDuring the trial
6MonitoringDuring the trial
7Close-OutDatabase lock

We know how Nigeria's health systems actually work — not just how they look on paper.

Participant dignity and safety are the starting point of a study design, not a compliance afterthought.

Built to flex from a single-site pilot to a multi-country program without re-inventing the approach.

Local footing means faster site activation and fewer surprises at the approval stage.

What we do

The way sponsors manage programs

Not a list of departments — the actual phases a clinical development program moves through, from first feasibility question to database lock.

Technology enabled — we use proprietary digital tools to support feasibility assessment and trial execution, with every output reviewed by our clinical team.

Phase 1

Before the Trial

Feasibility

Assessing whether a protocol can realistically run at a given site or in a given region — patient population, competing studies, and investigator capacity — before a sponsor commits resources to it.

Site Selection

Evaluating candidate sites against the protocol's actual requirements — staffing, equipment, patient volume, and track record — not just what's on a capability questionnaire.

Regulatory Strategy

Mapping the approval pathway through relevant regulatory authorities and ethics committees early, so submission timing is built into the study plan rather than discovered midway through it.

Phase 2

Study Start-Up

Site Activation

Moving a qualified site from selection to first-patient-in — contracting, training, and readiness checks completed against an activation timeline built around the actual site.

Contracts

Site and vendor agreements negotiated and executed in step with activation timelines, so contracting doesn't become the bottleneck holding up a ready site.

Vendor Management

Coordinating laboratory, logistics, and other third-party vendors so their timelines stay aligned with the site's own start-up schedule.

Laboratory Planning

Central and local laboratory testing coordinated alongside sourcing, storage, and cold-chain logistics — including import handling for studies bringing product into Nigeria.

Phase 3

During the Trial

Clinical Operations

Day-to-day management of site performance, timelines, and budget against a single project plan — one team holding both the site-level and study-level view.

Monitoring

Routine and close-out monitoring, source data verification, and CAPA follow-through, tracked consistently across every site in the study.

Recruitment

Recruitment and retention built around the actual population and geography in front of us — informed consent logistics and retention approaches that account for travel distance and community trust-building.

Data Management

EDC setup, data cleaning, and query resolution built into how data moves from site to database — quality checked at the source, not after the fact.

Phase 4

Study Close-Out

Database Lock

Final data cleaning, query resolution, and sign-off coordinated across sites to bring the database to lock on schedule.

Close-Out Visits

Site close-out conducted with the same rigor as activation — reconciling records, resolving outstanding queries, and confirming regulatory documentation is complete.

Inspection Readiness

Site files and trial documentation maintained in a state ready for sponsor audit or regulatory inspection at any point — not assembled after a close-out notice arrives.

Clinical Study Support

Ongoing support through reporting and publication-stage requests, including data queries that arise after a site has formally closed.

Why MedNova Clinical Development

What sponsors are actually choosing

01

Local operational expertise

Direct familiarity with Nigeria's site landscape and health systems — not a template applied from elsewhere.

02

Faster study start-up

Site activation timelines built around the actual site and its regulatory pathway, not a generic template.

03

Integrated regulatory support

Regulatory strategy runs alongside operations at every phase — not handled separately, and not just at submission.

04

Quality-first execution

GCP compliance and audit readiness built into how the work happens, rather than checked after the fact.

Industries We Support

Built for sponsors across the development landscape

Pharmaceutical Companies Biotechnology Companies Medical Device Companies Vaccine Developers CROs NGOs Government Agencies Academic Research
Insights

Perspective from the field

Writing on African clinical development, regulatory strategy, and trial readiness — drawn from the work itself, not general commentary.

African Clinical Development

What sponsors get wrong about running trials in West Africa

On the gap between template planning and what site-level execution actually requires.

Coming soon
Regulatory Strategy

Navigating regional regulatory and ethics review

A practical look at sequencing regulatory and ethics submissions against a real study timeline.

Coming soon
Trial Readiness

What "site-ready" actually means

Why feasibility on paper and feasibility on the ground are two different assessments.

Coming soon
About the team

Built for sponsors expanding into Africa

MedNova Clinical Development is led by a team with hands-on clinical operations and regulatory experience, applied directly to running programs in Nigeria and West Africa — local expertise, regulatory knowledge, and operational execution, held together by one accountable team.

Lagos-based, region-focusedOperating from Nigeria, built for regional trial execution
Locally groundedDirect familiarity with Nigeria's regulatory and site landscape
Free Self-Assessment

Trial Site Feasibility Readiness Checker

Answer six questions to get an instant readiness score for your planned study in Nigeria or West Africa — a real assessment tool, not a demo.

Readiness Score

    Let's talk about your trial

    Whether you're scoping site feasibility or ready to activate — we'd like to hear what you're working on.