Delivering world-class, standardized science for African trials.
At Xcene Research, we understand that dependable, high-quality laboratory data underpins the foundation of every successful clinical trial. Our Xcene Laboratory Services provide a central laboratory platform built to global scientific and operational standards yet uniquely tailored to the realities and opportunities of Africa’s research ecosystem.
By integrating diagnostics, molecular and genomic research, bioanalytical testing, and sample-logistics excellence, we deliver a single, harmonized solution that supports early-phase (Phase I–II) and late-phase (Phase III–IV) studies across the continent.
Our model mirrors the operational rigor of leading global central laboratories offering standardized testing procedures, validated analytical platforms, and unified data workflows while embedding the regional accessibility, regulatory alignment, and cultural understanding essential for conducting complex studies in Africa.
Integrated capabilities, purpose-built for Africa
At the heart of our platform lies Xcene Laboratories & Diagnostics (XLD), a state-of-the-art facility that is GCLP, CAP, and ISO 15189 compliant, ensuring every assay and dataset meets international regulatory requirements.
Through XLD, we provide the scientific depth, logistical agility, and data integrity that global sponsors expect delivered locally, with the precision and efficiency required for today’s accelerated development timelines. Whether supporting clinical trial testing, BA/BE studies, PK/PD modeling, or molecular and genomic biomarker discovery, our central laboratory infrastructure ensures that sponsors receive standardized, reproducible, and regulatory-grade data, empowering confident decision-making from study start-up through submission.
Built on state-of-the-art technology, harmonized processes, and unified data architecture, Xcene’s central laboratory eliminates integration challenges and ensures methodological consistency across every test and site. Global best practices emphasize the importance of unified laboratory platforms and specimen-logistics networks for reliable, reproducible results anywhere in the world principles that XLD has embedded into its operating model.
All XLD laboratories operate with harmonized SOPs, and instrumentation, ensuring consistency across every assay. Data from all analytical platforms flow seamlessly into a centralized Laboratory Information Management System (LIMS), enabling real-time visibility, traceability, and quality oversight across the entire sample lifecycle.
How We Deliver – Diagnostics, Genomics & Bioanalytics
At Xcene Laboratories & Diagnostics (XLD), we integrate advanced diagnostic testing and molecular & genomic research under one roof, delivering scientifically rigorous, standardized, and regulatory-compliant laboratory services for sponsors conducting trials across Africa.
Our centralized facility provides the full spectrum of clinical laboratory testing, from routine safety analysis to complex molecular & genomic and biomarker-driven assays, ensuring every result supports informed, data-driven decision making.
Our Diagnostic Services include:
- Safety Testing: Comprehensive hematology, clinical chemistry, immunology, and microbiology panels for routine participant monitoring.
- Specialized Disease Panels: Infectious disease, oncology, and metabolic disorder panels designed to support therapeutic-area–specific protocols.
- Rapid Turnaround: Automated workflows, integrated data systems, and continuous lab operation ensure timely sample processing and reliable reporting.
Our Molecular & Genomics Research Services include:
- Next-Generation Sequencing (NGS) for targeted gene sequencing, whole genome sequencing, exome sequencing, transcriptomics, metabolomics, e.t.c
- PCR-based molecular Assays for target identification, genotyping, and precision-medicine trials
- Pharmacogenetics and Gene-Expression Profiling to stratify participants, identify responders, and optimize dosing strategies.
- Bioinformatics and Biostatistics Integration to interpret complex genomic data, linking molecular findings to clinical endpoints and real-world outcomes.
Our molecular & genomic scientists collaborate directly with sponsors to design biomarker strategies that incorporate molecular and genomic endpoints, ensuring that all assays are validated in accordance with ICH, FDA, and EMA standards. This enables the generation of robust, regulatory-ready data that support precision-medicine, targeted-therapy, and pharmacogenomic studies in diverse African populations.
Comprehensive Sample Analysis and Bioanalytical Excellence
Harmonized methodologies, standardized instrumentation, and robust logistics are at the core of our bioanalytical operations. Through Xcene Laboratory Services, we offer an extensive portfolio of assays and analytical services to support both early-phase (Phases I–II) and late-phase (Phases III–IV) trials.
Our Bioanalytical and Clinica
Trial Testing Capabilities include:
- Clinical Trial Sample Analysis: Comprehensive panels for hematology, chemistry, serology, microbiology, and using validated instruments under GCLP conditions.
- Bioavailability / Bioequivalence (BA/BE) & PK/PD Analysis: Quantitative measurement of drug concentration, metabolism, and exposure using validated LC-MS/MS and HPLC platforms. Our on-site pharmacy and PK/PD team ensure rapid sample turnaround, enabling real-time decision-making.
- Biomarker Discovery & Validation: Multiplex immunoassays, flow cytometry, immunophenotyping, ELISA, and bead-based assays to evaluate pharmacodynamics, immune response, and treatment efficacy.
- Safety & Specialty Testing: Coagulation studies, endocrine and metabolic panels, therapeutic drug monitoring, and toxicology testing to support ongoing patient safety.
All assays follow Good Clinical Laboratory Practice (GCLP) and are validated according to ICH, FDA, and WHO guidelines. Our Quality Management System (QMS) ensures that every data point and result is traceable from collection through analysis, in alignment with Good Distribution Practice (GDP) requirements for documentation and sample traceability.
Using harmonized SOPs, and a centralized Laboratory Information Management System (LIMS), we deliver standardized, high-quality data that support global submission requirements while maintaining operational efficiency in Africa’s dynamic research environment.
Flexible kit production and logistics
Industry best practices underscore the importance of standardized kits and responsive logistics to reduce site burden and ensure timely processing. XLD provides customized specimen collection kits for each protocol, including pre-barcoded tubes and materials for safety tests, genomics, PK/PD, and BA/BE sampling. Our logistics team coordinates courier pick-ups, monitors cold chain integrity, and manages customs clearance and permits in collaboration with NAFDAC and other authorities.
We maintain a regional network of partner laboratories and collection points across Nigeria, Ghana, Kenya, Uganda and Zambia, reducing transit time and preserving sample integrity. For remote or resource-limited sites, we offer dry blood spot and micro-sampling solutions to limit sample volume and shipping requirements.
Data management and real-time visibility
Effective central laboratories rely on integrated data management systems and real-time dashboards for sample tracking and decision support. Building on this, XLD provides a secure web portal for sponsors and investigators to view sample status, laboratory results, and quality control metrics in real time. Our system interfaces with Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) to streamline data reconciliation.
For BA/BE and PK/PD studies, our bioanalytical team can generate pharmacokinetic parameters rapidly and share validated datasets through secure portals, accelerating data review and regulatory submission.
All data transmissions are encrypted and managed under 21 CFR Part 11 and ICH E6 (R3) requirements, ensuring full traceability and compliance.
Commitment to quality and compliance
Our central laboratory operates under a validated quality management system incorporating GCLP and ISO 15189 requirements.
All laboratory operations follow rigorous quality controls, method validations, and continuous monitoring to ensure data accuracy, reproducibility, and regulatory compliance. Our scientists and technologists undergo ongoing training, competency assessments, and proficiency testing, maintaining readiness for inspections and audits by both sponsors and regulatory authorities.
We operate seven days a week to ensure timely processing of samples and rapid results. Our Quality Assurance team applies Six Sigma methodologies and continuous improvement principles to monitor performance, reduce variability, and drive operational excellence across all analytical and logistical processes.
Why partner with Xcene for central lab services?
Choosing the right central laboratory partner is critical to the success of every clinical trial.
At Xcene Research, we combine global quality systems with deep regional expertise to deliver a seamless, quality-driven, and compliant laboratory experience for sponsors conducting trials across Africa.
Why Sponsors Choose Xcene:
- Single Point of Accountability: One integrated contract covering all laboratory needs — from safety testing and genomics to PK/PD, BA/BE, and specialized assays.
- Regional Agility: Our Africa-based infrastructure delivers global-standard laboratory performance while minimizing logistics complexity, timelines, and costs.
- Integrated Sample Lifecycle: We manage the entire process from kit production and logistics to biorepository storage, analysis, and data integration ensuring full traceability and operational efficiency.
- Regulatory Alignment: Our Quality Management System (QMS) aligns with NAFDAC, FDA, EMA, and WHO requirements, ensuring regulatory-ready data for global submissions.
- Sponsor & Patient Centricity: Real-time data access, rapid turnaround, and personalized scientific support deliver first-time quality results and strengthen decision-making confidence.
By incorporating proven global best practices and tailoring them to Africa’s research landscape, Xcene Laboratory Services offers an unparalleled central lab solution. Whether you need diagnostics, genomic and molecular research, clinical trial sample analysis or BA/BE and PK/PD support, XLD delivers dependable results to accelerate your drug development journey.
“At Xcene Research, our diagnostic, genomic, and bioanalytical services form the scientific core of every trial transforming complex data into meaningful insights that advance clinical innovation across Africa.”
