End-to-End Site Management

From site identification and regulatory submission to patient recruitment, GCP monitoring and study close-out.

Biopharmaal manages every stage of the clinical trial site lifecycle to ICH E6 R2 standard.

01

Site Identification and Feasibility

Rigorous site selection using our PVAC-aligned national readiness checklist.
We assess ethics committee status, cold chain capability, lab accreditation, PI experience and patient catchment – delivering a sponsor ready feasibility report.

02

Regulatory Navigation

Expert management of NAFDAC clinical trial applications, NHREC ethics submissions, and site-level compliance.
We commit to SIV readiness within 90 days – vs. 6-9 months with global CROs.

03

Site Start-Up & Initiation

-Comprehensive site activation: protocol training, SIV coordination, CRC orientation, IMP receipt and storage verification and investigator agreement execution. Delivered with our quality system.

04

Digital Patient Recruitment

Nigeria’s first SMO – operated digital recruitment engine – WhatsApp broadcast channels, SMS pre-screening APIs, and health app partnerships. Pre-screened volunteer databases segmented by condition, age, and location.

05

Community Trust Programme (CTEP)

Nigerias first formal community ethics education programme for clinical trials. Trilingual consent materials (Yoruba, Hausa, Igbo) community town halls, and trained community liaisons – driving enrolment rates and sponsor ESG compliance simultaneously.

06

GCP Monitoring & Quality Assurance

Routine and triggered monitoring visits, SAE reporting support protocol deviation management, and data integrity assurance. All delivered to ICH E6 R2 standard with full audit trail via REDCap EDC.

07

GCP Training Services

ICH E6 R2 GCP certification training for investigators, CRCs, site pharmacists and ethics committee members. Workshop – based delivery at partner hospitals, aligned with PVAC’s national site capacity building programme.

08

Sickle Cell Disease Programme

Nigeria’s first dedicated SCD trial site management service. Pre-consented patient database haematology site infrastructure.

09

Regulatory Consulting

Standalone consulting for sponsors navigating Nigerian and West African regulatory environments for the first time. Includes NAFDAC application strategy, ethics committee navigation and international regulatory alignment.

Our Approach

Streamlined Processes for Optimal Results

Step

01

Discovery

Understanding client needs to tailor our services effectively.

Step

02

Implementation

Establishing efficient processes for rapid site initiation and compliance.

Step

03

Support

Providing ongoing guidance and assistance throughout the research process.

READY TO START

Let’s Build Your Nigerian Trial Site Together

Whether you are global pharma sponsor, a CRO seeking a West Africa subcontract partner, or an NGO researcher needing GCP-compliant site management – we are ready to talk.