Clinical Trial Management

The start-up phase defines the scientific and operational trajectory of every clinical trial. It demands precise coordination of systems, processes, vendors, and regulatory deliverables, balancing speed, quality, and compliance to create a foundation for reliable study outcomes.

At this stage, the success of a trial is determined by the efficiency of site selection, the accuracy of feasibility assessments, and the readiness of investigators to conduct GCP-compliant research.

How Xcene Research delivers:

Our site intelligence and activation specialists perform comprehensive feasibility and due-diligence reviews of potential investigators and institutions. We apply data-driven site intelligence to identify and activate high-performing research centers across Sub-Saharan Africa.

We combine site mapping, geographic analysis, and disease-prevalence data to match the right investigators and patient populations with each study’s objectives.

Our specialists assess infrastructure, regulatory readiness, and cultural factors to ensure sites are compliant, accessible, and ready for first-patient-in.

With rigorous quality control and transparent documentation, we deliver fast, compliant, and strategically positioned site activation that sets every trial up for success.

Achieving a high-quality clinical trial begins with a well-planned and efficiently managed start-up phase. At Xcene Research, we understand that this stage is critical to ensuring sites are fully prepared, compliant, and operationally ready before enrollment begins.

How Xcene Research delivers:

Our dedicated start-up team, composed of globally experienced professionals with deep regional expertise, manages every aspect of the process across Sub-Saharan Africa.

We coordinate all pre-initiation activities from regulatory and ethics submissions, contract and budget finalization, and essential document review, to verifying site infrastructure, SOP compliance, and staff readiness ahead of the Site Initiation Visit (SIV).

Through proactive communication, risk mitigation, and rigorous quality oversight, we ensure that every site passes its “gate check” meeting the highest standards of Good Clinical Practice (GCP) and operational excellence before enrolling its first participant.

“Accelerate your commercialization goals with confidence through Xcene Research’s regulatory expertise, strategic foresight, and flawless execution.”

At Xcene Research, our Regulatory Affairs team brings deep scientific understanding and extensive regional experience to guide sponsors through the complex and evolving regulatory landscape across Sub-Saharan Africa. We provide end-to-end regulatory strategy and operational support from initial planning and feasibility through submission, agency engagement, and post-approval oversight.

Our experts develop customized strategies aligned with each sponsor’s program goals, ensuring that every regulatory requirement is anticipated, efficiently managed, and fully compliant.

How Xcene Research delivers:

• Conducting strategic regulatory analyses to identify the optimal pathway, documentation, and timelines for each investigational product and indication.
• Managing Clinical Trial Authorization (CTA) submissions, ethics approvals, import licensing, and safety reporting in full compliance with ICH-GCP and national regulations.
• Maintaining continuous dialogue with regulatory authorities to expedite reviews and resolve queries transparently.
• Leveraging regulatory-intelligence platforms to monitor, forecast, and adapt to policy updates and emerging trends.
• Providing ongoing advisory support throughout the product development lifecycle to ensure sustained compliance and accelerated time-to-market.

With a strong presence in Nigeria, Kenya, Ghana, Uganda, Tanzania and Zambia, Xcene Research has built trusted relationships with competent authorities and ethics committees through years of collaboration and transparent communication. This foundation enables us to navigate complex approval environments effectively and deliver predictable, compliant outcomes for global sponsors.

This strategic expansion is driven by these regions' growing pharmaceutical infrastructure, supportive government policies, and availability of skilled investigators, cementing Xcene Research as your definitive partner for clinical research growth across a rapidly developing continent.

At Xcene Research, effective project management is recognized as the cornerstone of every successful clinical trial. Industry experts note that poor project management can result in study delays, rising costs or even failure to launch, while strong project management ensures trials proceed smoothly, efficiently and in compliance with strict regulations. Our experienced Project Management team combines scientific insight, regulatory understanding and operational expertise to oversee the full lifecycle of a study from early feasibility and protocol design through execution, closeout and final deliverables.

Project managers act as gatekeepers of safety and compliance, proactively identifying, evaluating and mitigating risks throughout the trial rather than treating risk management as a oneoff exercise. This riskbased mindset, aligned with Good Clinical Practice (GCP), helps to prioritize activities, reduce protocol deviations and safeguard patients. We work transparently and collaboratively with sponsors to ensure study objectives are achieved on time and within budget while maintaining uncompromising quality and participant wellbeing.

How Xcene Research delivers:

Our Project Managers leverage integrated digital platforms that offer realtime oversight and enable proactive management across all phases of a study:

• Clinical Trial Management System (CTMS): A centralised platform that manages study planning, site selection, patient recruitment, budgeting and trial progress. CTMS modules consolidate timelines, site performance metrics and protocol deviations, providing sponsors with instant visibility into study status.
• Electronic Trial Master File (eTMF): A secure digital repository that stores essential trial documents to ensure compliance and audit readiness. Integrated eTMF functions capture version history and timestamps, simplifying audits and regulatory inspections.
• Electronic Data Capture (EDC) and realtime dashboards: Modern EDC platforms flag anomalies and missing data as they occur, while dashboards with colourcoded severity indicators and heat maps allow our team to prioritise issues quickly.
• Risk Assessment and Mitigation tools: Structured risk plans and tools such as the Risk Assessment Categorisation Tool (RACT) help score and rank risks by likelihood and impact. Integrated monitoring systems alert project managers to emerging risks, enabling timely mitigation and escalation.
• Project Governance Framework: A structured communication process that fosters accountability and ensures all stakeholders from site staff to sponsors are aligned on objectives, timelines and risk mitigation strategies.

By integrating these systems and frameworks, we reduce data silos, automate compliance tasks and give sponsors unified, realtime visibility into their studies. This approach delivers predictable outcomes, maintains regulatory compliance and minimises operational risk, upholding Xcene’s commitment to firsttime quality.

Our project management philosophy centres on clarity, control and confidence. By combining robust digital infrastructure with scientific and regulatory expertise, we ensure each study advances efficiently, transparently and with the utmost respect for participants delivering value to sponsors and better outcomes for patients.

The laboratory is the scientific backbone of every clinical trial providing the data needed to evaluate safety, efficacy, and patient outcomes. At Xcene Research, our Laboratory Management team combines deep expertise in laboratory medicine, clinical research, and bioanalytical sciences to ensure the generation of quality, accurate, reproducible, reliable and regulatory-compliant data across all Phases I–IV studies.

How Xcene Research delivers:

We coordinate all laboratory-related and logistical aspects of a clinical trial, working closely with investigator sites and analytical labs to integrate laboratory operations seamlessly into the wider clinical workflow. Our approach emphasizes robust sample management, strict quality standards and advanced digital tracking:

Sample Lifecycle Management: We oversee study sample collection, labelling, processing, storage and shipment, maintaining a full chain of custody and cold-chain integrity.

• Compliance & Quality Systems: We identify and partner with central laboratories that operate under Good Clinical Laboratory Practice (GCLP) and maintain accreditation with recognized international standards such as CAP, CLIA and ISO 15189. These frameworks ensure the accuracy, reliability, and traceability of all laboratory results, providing confidence that data generated meets global regulatory expectations and supports the highest standards of scientific integrity and patient safety.
• Bioanalytical Sample Coordination: We coordinate closely with investigator sites to ensure that blood & urine biomarker and pharmacokinetic/pharmacodynamic (PK/PD) samples are collected according to protocol requirements and shipped within defined stability timeframes. Our team collaborates seamlessly with site personnel, sponsor laboratories, and third-party vendors to maintain sample integrity, regulatory compliance, and data reliability throughout the process.
• Laboratory Oversight: We leverage Integrated Laboratory Information Management Systems (LIMS) and real-time performance dashboards to monitor sample status, turnaround times, and data reporting across all study sites. Our laboratory management team works closely with site staff to ensure timely resolution of laboratory queries, maintaining consistent communication between investigators, sponsor laboratories, and third-party vendors. By addressing discrepancies promptly and tracking data in real time, we ensure that final laboratory results are delivered accurately, compliantly, and within sponsor-defined timelines.

Training & SOP Harmonisation: We implement harmonised standard operating procedures and provide continuous training to site and laboratory personnel, ensuring consistent practices and regulatory adherence. By combining scientific rigour with operational excellence, Xcene Research transforms laboratory operations into scientific certainty ensuring that every data point reflects the integrity and quality sponsors expect. Through proactive communication, strict compliance and continuous process optimization, our Laboratory Management team plays a pivotal role in advancing each study from sample collection to validated results

Our Clinical Monitoring team ensures that every study site upholds the highest standards of Good Clinical Practice (GCP), regulatory compliance, and patient safety while enabling data integrity and transparency throughout the clinical trial lifecycle. Guided by international regulatory frameworks, we apply a risk-based monitoring approach that focuses on critical study parameters and combines on-site visits, remote data review, and centralized analytics to oversee trials efficiently.

This integrated model enhances human-subject protection, regulatory compliance, and data quality by concentrating resources on the most meaningful risks ensuring every study is executed with transparency, precision, and scientific rigor.

How Xcene Research delivers

Our Clinical Research Associates (CRAs) are trained in modern, risk-based methodologies that combine on-site, remote, and centralized monitoring to deliver comprehensive oversight tailored to each study’s complexity and geographic spread.

We deploy multiple monitoring modalities:

• On-Site Monitoring: Direct source data verification (SDV), safety checks, drug accountability, and protocol adherence verification through scheduled site visits.
• Remote Monitoring: Secure access to electronic source data (eSource) and electronic data capture (EDC) platforms, allowing continuous review of documentation and data entry without interrupting site operations.
• Centralized Monitoring: Use of data analytics and statistical algorithms to detect outliers, deviations, and data trends across multiple sites in real time.
• AI-Enhanced Oversight: Integration of machine learning and predictive analytics to identify emerging risks, optimize CRA focus, and improve operational efficiency.
• Decentralized Clinical Trial (DCT) Monitoring: Implementation of remote patient engagement tools, ePRO/eCOA systems, and telemedicine-based safety follow-ups to support hybrid and fully decentralized study models.

Our monitoring framework aligns with local regulations, NAFDAC, ICH E6(R3) and FDA/EMA risk-based monitoring guidance, ensuring that monitoring intensity is proportional to site performance and data risk.

Scientific and regional advantage:

Xcene’s multilingual CRAs and in-country monitors possess deep knowledge of Africa’s regulatory frameworks, site environments, and cultural nuances, enabling effective collaboration and participant-centered engagement. We maintain real-time communication with site teams, resolve data queries quickly, and deliver actionable insights through integrated Clinical Trial Management Systems (CTMS) and monitoring dashboards.

Through this scientifically informed, technology-driven, and regionally grounded approach, Xcene Research ensures:

• Continuous protection of participant rights, safety, and well-being.
• High-quality, verified, and inspection-ready clinical data.
• Efficient oversight that accelerates decision-making and reduces trial timelines.

At Xcene Research, quality is not an afterthought, it is the framework that defines everything we do. Our Quality Management System (QMS) is designed to ensure that every trial adheres to Good Clinical Practice (GCP), regulatory guidance and international quality standards. Clinical research quality assurance is a methodical process that guarantees studies are conducted in compliance with study protocols and regulatory requirements and under the ethical principles of GCP. It provides oversight to ensure that study planning, execution, data management, and reporting processes comply with applicable regulations and GCP requirements, thereby maintaining participant safety and ensuring data integrity. Key best practices include maintaining standard operating procedures (SOPs), conducting regular audits and inspections, providing ongoing training, and using reliable electronic data capture systems to reduce errors.

We maintain a robust Quality Management System (QMS) designed to ensure that all trial activities meet the standards set by ICH-GCP E6(R3), and local regulatory authorities as it applies to the region, such as NAFDAC, Ghana FDA, Kenya PPB, whilst meeting and exceeding our client expectations and requirements. Our system promotes continuous improvement, traceability, and audit readiness across every function and study phase.

How Xcene Research delivers

Quality Oversight & Governance: We implement a risk-based QMS that ensures independent oversight of clinical, laboratory, and operational processes. Our approach focuses on evaluating the effectiveness of quality controls and governance structures in place, ensuring that risk-based strategies are appropriately applied throughout the study lifecycle. Through proactive oversight and continuous quality evaluation, we help ensure that every project meets sponsor specifications, regulatory expectations, and ethical standards, reinforcing a culture of compliance and excellence across all functions.

• Audit & Inspection Management: Our QA auditors conduct internal, vendor, and investigator site audits to assess compliance with GCP requirements, applicable regulatory standards, and data integrity principles. We also provide oversight and support to sponsors and sites during regulatory inspections, ensuring that all documentation and systems remain inspection-ready at all times.
• Regulatory Alignment: QA ensures all processes and documentation comply with applicable global and local regulations. We monitor evolving regulatory requirements, integrate them into our QMS, and maintain inspection readiness to ensure continuous compliance and operational integrity.
• Standard Operating Procedures (SOPs): Our continuously updated SOP library integrates applicable regulatory requirements and global standards, ensuring consistent, validated execution of all operational tasks. Following SOPs is a recognized best practice for ensuring consistency in trial processes.
• Training & Competency Development: We deliver mandatory GCP, GDP and qualitysystem training for staff, investigators and partners. Ongoing education is a core component of quality assurance and reinforces a culture of compliance.
• CAPA & Continuous Improvement: Audit/inspection findings and quality reviews feed into our Corrective and Preventive Action (CAPA) process, monitored via digital tracking tools to ensure timely resolution and process optimisation. Continuous improvement is essential to maintain quality in an evolving research landscape.

Our Commitment

We understand that the African research landscape demands both local regulatory fluency and global quality precision. Xcene is committed to upholding the highest standards of quality, compliance, and integrity across all clinical research activities. We ensure that every process, system, and partnership reflects regulatory expectations, sponsor requirements, and ethical obligations. Through proactive oversight, continuous improvement, and a risk-based approach, we safeguard participant safety, data reliability, and the credibility of the research entrusted to us.

The protection of participants and ensuring scientific validity are at the heart of every clinical trial. At Xcene Research, our Medical Monitoring and Pharmacovigilance (PV) services provide continuous oversight of participant safety, protocol adherence, and data integrity across all study phases. Our medical monitors and safety physicians integrate Good Clinical Practice (GCP) principles, ICH E2A–E2F guidelines, and local regulatory requirements from NAFDAC, NHREC, and WHO to maintain the highest standards of ethical and clinical conduct.

How Xcene Research delivers:

• Comprehensive Medical Oversight: Our qualified physicians and medical monitors provide 24/7 safety oversight verifying subject eligibility, assessing adverse events (AEs) and serious adverse events (SAEs), and ensuring prompt reporting to regulatory authorities.
• Safety Data Review: We perform real-time medical review of safety data, including laboratory results, vital signs, and clinical outcomes, to identify trends or emerging risks. Our team collaborates with sponsors and investigators to ensure accurate interpretation of events and appropriate medical management.
• Pharmacovigilance Operations: Xcene Research maintains a robust PV system compliant with ICH E2A, Good Pharmacovigilance Practice (GVP), and NAFDAC post-marketing safety surveillance requirements. We manage safety databases, prepare aggregate safety reports, and ensure that case processing and follow-up are timely and complete.
• Risk Management & Signal Detection: We apply structured risk management plans (RMPs) and employ signal-detection algorithms to identify safety trends across sites or regions. Our experts ensure that risk minimization measures are documented, implemented, and evaluated for effectiveness.
• Regulatory & Sponsor Communication: Our safety team liaises with sponsors, investigators, and competent authorities to ensure clear, two-way communication. This collaboration ensures SAE reporting timelines are met, facilitates safety updates, and ensures audit readiness.
• Training & Compliance: All site and study staff receive continuous safety training, ensuring accurate AE capturing, reporting and documentation aligned with GCP and local pharmacovigilance requirements.

Scientific and regional strength:

With operations across Nigeria, Ghana, Kenya, Uganda, Tanzania and Zambia, Xcene Research has developed strong partnerships with regional ethics committees and regulatory authorities. This local insight, combined with global safety expertise, allows us to manage safety data efficiently while navigating Africa’s evolving pharmacovigilance landscape with precision and compliance.

Efficient supply-chain management is critical to the integrity and continuity of every clinical trial. We provide end-to-end clinical supply management solutions that ensure investigational products (IP) and ancillary materials are planned, sourced, packaged, labeled, distributed, and reconciled in full compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and local regulatory requirements such as those defined by NAFDAC and local regulations.

How Xcene Research delivers:

• Strategic Planning & Forecasting: We partner with sponsors to forecast IP and consumable needs based on protocol design, enrollment rates, and site activation timelines, minimizing the risk of shortages or overstocking.
• Sourcing & Vendor Coordination: Our logistics experts coordinate with qualified suppliers and depots, ensuring that all materials meet GMP standards and that vendor performance is tracked through approved quality agreements.
• Packaging & Labeling: We manage IP packaging and labeling processes in compliance with country-specific language and labeling regulations, ensuring alignment with Annex 13, ICH Q9, NAFDAC guidelines and local regulations.
• Storage & Distribution: Leveraging temperature-controlled depots and validated cold-chain logistics, we maintain product integrity from receipt to administration. Real-time tracking systems monitor temperature excursions, delivery status, and inventory levels across sites.
• Accountability & Reconciliation: We maintain full chain-of-custody records, document dispensing logs, and reconcile unused or returned supplies in accordance with GDP and ICH Q10 quality-system principles.

By combining regulatory precision with operational agility, Xcene Research guarantees timely, compliant, and transparent IP delivery that supports patient safety, site readiness, and audit readiness.

Accurate, compliant, and well-curated data are the foundation of credible clinical research. At Xcene Research, our Data Management team ensures that every dataset we produce meets international standards for integrity, traceability, and regulatory readiness.

We combine advanced digital infrastructure with deep clinical expertise to ensure that data collected across diverse sites and populations is reliable, validated, and ready for regulatory submission empowering faster, evidence-based decision-making for sponsors and regulators alike.

How Xcene Research Delivers

We provide end-to-end data management solutions spanning the full clinical data lifecycle from database design and electronic data capture (EDC) to data cleaning, validation, reconciliation, and statistical-analysis preparation.

Our systems and processes are built in accordance with 21 CFR Part 11, ICH E6 (R3), and Good Clinical Data Management Practices (GCDMP), ensuring secure, auditable, and fully compliant data workflows.

Our Core Capabilities

• Database Design & Build: Custom case report forms (CRFs) and edit checks are developed using validated EDC platforms (e.g., Medidata Rave, OpenClinica, REDCap) tailored to each study’s protocol, endpoints, and data flow.
• Data Capture & Cleaning: Automated edit checks, discrepancy management tools, and real-time validation rules detect and correct errors early, reducing query turnaround time and improving data accuracy.
• Reconciliation & Lock: Integration with safety, laboratory, and pharmacovigilance databases ensures that adverse-event and laboratory data are fully reconciled before database lock, guaranteeing a clean, analysis-ready dataset.
• Compliance & Security: Robust data protection standards including encryption, role-based access controls, and GDPR/HIPAA-compliant servers safeguard participant confidentiality and data integrity throughout the research process.
• Reporting & Insights: Interactive dashboards provide sponsors with real-time visibility into data completeness, query metrics, and key performance indicators, supporting proactive decision-making and operational transparency.
• System Integration: Seamless system integration with IxRS, eCOA/ePRO to enable real-time data capture and automated reconciliation, minimizing manual effort and reducing discrepancies. Connecting these systems enhances data traceability and streamlines workflow.

By combining advanced technology with experienced data managers, biostatisticians, and clinical programmers, Xcene Research transforms complex trial data into regulatory-grade evidence ready for submission to NAFDAC, FDA, EMA, and other global authorities.

Cardiac safety is a critical component of clinical development, particularly in assessing the electrophysiological effects and cardiotoxic potential of investigational products. We offer a comprehensive portfolio of electrocardiogram (ECG) services designed to support cardiac safety evaluation across all phases of clinical research.

How Xcene Research delivers:

Through our collaboration with Xcene Laboratories & Diagnostics, a state-of-the-art bioanalytical and central-lab facility, we provide sponsors with access to advanced centralized ECG analysis, expert medical interpretation, and integrated cardiac-safety assessments that meet global regulatory expectations.

Our ECG capabilities include:

• Centralized ECG Management: Standardized acquisition, transfer, and storage of ECG data using validated digital platforms compliant with ICH E14, FDA, and EMA cardiac-safety guidelines.
• Quantitative & Qualitative Analysis: Measurement of QT/QTc intervals, PR, QRS, and T-wave morphology changes performed by experienced cardiologists and certified ECG technicians.
• Continuous Monitoring & Data Integration: Real-time ECG data collection and review via electronic data capture (EDC) systems to identify early cardiac-safety signals and facilitate rapid decision-making.
• AI-Assisted Interpretation: Use of algorithm-driven tools for beat-to-beat variability analysis, arrhythmia detection, and automated signal-quality validation, followed by expert over-read.
• Data Integrity & Compliance: ECG data are processed within GCP-compliant environments and integrated into the clinical database under full audit-trail transparency for regulatory submissions.

By combining precision technology with expert cardiology oversight, Xcene Research ensures that every cardiac data point collected is accurate, interpretable, and regulatory-ready providing sponsors with robust evidence for the safety and efficacy of their investigational therapies.

Patient recruitment is one of the most decisive and scientifically complex aspects of clinical research. The ability to identify, engage, and retain eligible participants directly determines a study’s feasibility, data quality, and regulatory success.

At Xcene Research, we address this challenge through a data-driven, technology-enabled, and community-anchored recruitment model that merges global clinical-trial standards with local healthcare realities across Sub-Saharan Africa. Our approach recognizes that Africa’s genetic diversity, disease burden, and emerging healthcare infrastructure present both vast potential and unique logistical challenges for patient enrollment.

By combining digital intelligence, real-world data, and regional expertise, we ensure that recruitment is efficient, ethical, and inclusive, enabling sponsors to generate data that truly reflects real-world populations.

How Xcene Research delivers

Our proprietary XP Recruiter™ platform operationalizes this model, translating our patient recruitment strategy into measurable, data-driven outcomes. It combines AI-assisted pre-screening, referral analytics, and geo-mapping of trial sites and participant locations to identify eligible participants rapidly and accurately.

Key features of XP Recruiter™ include:

• AI-assisted pre-screening algorithms that match potential participants against study inclusion and exclusion criteria.
• Supports integration with hospital EMRs and disease registries, enabling pre-identification of eligible patients while preserving data privacy.
• Geo-mapping of trial sites and participant locations to to ensure targeted outreach and optimized logistics.
• Real-time dashboards that monitor enrollment progress, conversion rates, and retention metrics across all sites.

Beyond technology, our recruitment success is driven by trusted partnerships. We collaborate closely with investigator networks, healthcare providers, and patient-advocacy groups to build awareness and engagement within local communities.

Our multilingual outreach specialists and community health educators ensure that all communication is culturally sensitive, ethically compliant, and fully aligned with informed-consent regulations.

Our patient-recruitment services include:

• Digital and community-based pre-screening via XP Recruiter™.
• Collaboration with key opinion leaders and site investigators to refine recruitment strategies.
• Development of culturally relevant recruitment materials and educational campaigns.
• Continuous tracking of recruitment and retention metrics through centralized dashboards.
• On-site and virtual engagement programs to maintain participant motivation and adherence.

By combining AI-driven insights, human connection, and operational precision, Xcene Research consistently achieves enrollment targets faster while maintaining the highest standards of GCP, ethics, and patient care.

The Platform’s AI models are continually refined using confirmed enrollment outcomes, improving the precision of future participant matching.

XP Recruiter also incorporates NDPC-compliant data protection, encrypted storage, and role-based access controls to ensure participant privacy and data integrity.

In today’s rapidly evolving clinical-research environment, strategic foresight and localized expertise are essential to successful trial execution. At Xcene Research, our Consulting Services help sponsors make informed, data-driven decisions across every stage of the drug and device development process from concept to clinical execution.

How Xcene Research delivers:

Our multidisciplinary consultants combine global experience with in-depth understanding of the African regulatory, operational, and healthcare landscape to guide sponsors in designing and optimizing studies that are both scientifically robust and regionally feasible.

Our consulting capabilities include:

Our consulting team’s insights are grounded in real-world operational data, extensive site networks, and decades of experience managing clinical programs across Africa’s most active research markets including Nigeria, Ghana, Kenya, Uganda, Tanzania and Zambia.

By combining scientific acumen with regional intelligence, Xcene Research helps sponsors translate complex challenges into executable strategies that achieve regulatory compliance, operational efficiency, and lasting impact.

Strong clinical research begins with capable, well-trained sites.

At Xcene Research, we believe that consistent education and capacity building are key to achieving quality, compliance, and operational excellence across every study. Our Site Training & Capacity Development programs are designed to strengthen the competence, confidence, and performance of investigators, study coordinators, pharmacists, and laboratory personnel throughout Sub-Saharan Africa.

How Xcene Research delivers:

We offer a robust curriculum that combines scientific depth, regulatory relevance, and practical application, ensuring that site teams are fully equipped to meet international and local standards.

Our programs cover:

• Good Clinical Practice (GCP) & ICH Guidelines: foundational training to ensure global compliance and ethical conduct.
• Protocol-Specific Training: detailed review of study design, procedures, and data-collection requirements to ensure consistency and accuracy.
• Safety Reporting & Pharmacovigilance: emphasizing the importance of adverse-event documentation, timely reporting, and risk mitigation.
• Data Management & Source Documentation: training on eSource, EDC, and data integrity principles for accurate and audit-ready records.
• Good Clinical Laboratory Practice (GCLP) and SOP Adherence: ensuring laboratory and clinical teams follow validated procedures aligned with regulatory expectations.

Strategic Partnership with ACRP:

To ensure global consistency and certification-level quality, Xcene Research has partnered with the Association of Clinical Research Professionals (ACRP) as our technical training partner.

Through this partnership, we integrate internationally recognized ACRP curricula and standards into our programs offering =our site staff and regional investigators access to cutting-edge, globally accredited clinical research education.

This collaboration also enables our teams to receive ACRP-endorsed continuing education credits (CEUs), aligning our regional training framework with global competency benchmarks.

Delivery Methods:

Our training programs are delivered through blended formats including instructor-led workshops, simulation-based exercises, and virtual learning platforms to reach diverse site teams efficiently. We also conduct refresher courses and performance evaluations throughout the study lifecycle to sustain operational excellence and minimize protocol deviations.

By investing in people and partnerships, Xcene Research is building a pipeline of qualified African clinical research professionals capable of executing world-class studies.

Our training programs not only strengthen site readiness but also advance Africa’s capacity to lead high-quality, compliant, and ethical research on a global scale.

Protecting participant data is fundamental to ethical, transparent, and compliant clinical research.
At Xcene Research, we uphold the highest standards of data privacy, information security, and regulatory compliance across all the countries in which we operate. Our approach integrates global data-protection frameworks such as GDPR, ISO 27001, and ICH-GCP, with local regulatory mandates, including Nigeria’s Data Protection Regulation (NDPR), Kenya’s Data Protection Act (2019), Ghana’s Data Protection Act (Act 843), South Africa’s POPIA, and Zambia’s ICT regulations.

We view data protection not merely as compliance, but as a reflection of our ethical duty to protect every participant’s dignity, rights, and trust.

How Xcene Research delivers

Our data privacy framework is built on strong governance, secure infrastructure, and continuous accountability, ensuring full compliance with local and international regulations while maintaining operational efficiency.

1. Governance & Oversight:

Xcene Research operates under a formal Data Protection and Information Security Governance Framework led by a registered Data Protection Officer (DPO). The DPO oversees data-protection registration, regulatory engagement, and internal audits, working closely with authorities such as NITDA (Nigeria), NAFDAC, and regional data-protection commissions.

Through Data Protection Impact Assessments (DPIAs) and continuous monitoring, we ensure that all data processing activities are lawful, ethical, and well-documented.

2. Regulatory Compliance:

We comply with national and regional data-protection laws in every country of operation, as well as international standards including GDPR and ISO 27001. Our procedures are designed to align with NDPR Implementation Guidelines, ensuring that data processing, storage, and transfer are governed by lawful bases, with breach notifications and risk assessments submitted within mandated timelines. Where cross-border data transfer occurs, Standard Contractual Clauses (SCCs) and Data Transfer Agreements (DTAs) are applied to ensure transparency and legality.

3. Information Security & Systems Controls:

Our digital infrastructure is secured through validated systems such as Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and electronic Trial Master File (eTMF) all fully 21 CFR Part 11 compliant. We apply AES-256 encryption, multi-factor authentication, and role-based access controls to ensure data confidentiality and integrity.

Periodic vulnerability scans and penetration testing by certified cybersecurity partners further strengthen our information-security posture.

4. Training & Awareness:

All employees, investigators, and third-party vendors undergo mandatory data-protection and cybersecurity training during onboarding and annually thereafter.

Training modules cover NDPR and GDPR principles, incident-response procedures, and sponsor-specific data-handling requirements. By cultivating a compliance-first culture, Xcene Research ensures that every stakeholder is equipped to handle sensitive information responsibly.

5. Participant Rights & Informed Consent:

Participants are fully informed, through ethics-approved consent documents, about how their data will be collected, stored, used, and shared.

We ensure clear communication in culturally relevant language, guaranteeing that participants understand their rights including the right to access, rectify, restrict, or withdraw consent in accordance with NDPR, GDPR, and POPIA.

6. Auditing, Documentation & Continuous Improvement:

Our Quality Assurance (QA) and DPO teams conduct regular internal audits and privacy assessments to verify compliance. Findings are tracked through Corrective and Preventive Action (CAPA) systems, ensuring continuous improvement and readiness for sponsor, regulatory, and ethics inspections.

Our Commitment

At Xcene Research, we believe that data protection is synonymous with participant protection. Through governance excellence, regulatory alignment, and secure technologies, we ensure that every dataset entrusted to us is handled with precision, confidentiality, and accountability.

By combining local regulatory fluency with global data-management standards, we provide sponsors with full confidence that their studies are compliant, ethical, and audit-ready across Africa.

Efficient drug product management is vital to the safety, integrity, and continuity of every clinical trial. At Xcene Research, our Drug Depot and Clinical Supply Storage services provide sponsors with fully compliant solutions for the receipt, storage, handling, distribution and reconciliation of investigational medicinal products (IMPs), comparators, and ancillary supplies across Sub-Saharan Africa. Crucially, we operate on a Delivered Duty Paid (DDP) incoterm basis, meaning Xcene Research assumes all risks, costs, and regulatory burdens associated with importation, customs clearance, and duty payment until the product reaches the research site, offering sponsors a truly seamless, hands-off solution

We recognize that improper storage or transport conditions can compromise the potency, stability, and safety of investigational products. To prevent this, Xcene Research ensures full adherence to Good Distribution Practice (GDP) guidelines, maintaining strict control of temperature, humidity, traceability, and security at every stage of the clinical supply chain.

How Xcene Research delivers:

GMP/GDPCompliant Infrastructure

Our depots operate under Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards, as well as WHO and NAFDAC guidance. GDP stipulates that drugs must be stored, handled and transported under conditions that prevent contamination, damage or deterioration.

Facilities include temperaturecontrolled zones (ambient, 2–8 °C, –20 °C and below), 24/7 temperature and humidity monitoring, backup power and validated coldchain equipment. NAFDAC’s GSDP guidelines emphasise that distributors must establish a quality management system with defined responsibilities, processes and risk management principles to ensure products remain within the legal supply chain.

Regulatory & Import Coordination

Our regulatory team manages import permits, customs documentation and incountry distribution licences on behalf of sponsors, liaising directly with NAFDAC and other authorities to ensure timely product clearance and full documentation traceability.

Controlled Receipt, Storage & Distribution

Each shipment undergoes documented visual inspection, verification and quarantine before release to active inventory. We employ validated couriers and temperaturecontrolled transport compliant with IATA Dangerous Goods Regulations, safeguarding product stability during transit.

Distribution activities follow written procedures and are systematically reviewed; critical steps are validated and any significant changes justified.

Inventory Management & Traceability

Our Inventory Management System (IMS) integrates with sponsors’ Clinical Trial Management Systems (CTMS) to maintain realtime visibility of stock levels, batch details and expiry dates. GDP guidelines stress the need for traceability from manufacturer to end user to prevent counterfeits and ensure quality.

Every product movement is logged, creating a full chainofcustody record that supports audit readiness and regulatory inspection.

Quality & Pharmacovigilance Alignment

Our Quality Assurance team oversees depot operations through a validated Quality Management System. NAFDAC’s guidelines require distributors to establish and maintain a QMS that defines responsibilities, processes and resources, and to ensure products and documentation satisfy quality requirements.

We handle product complaints, temperature excursions and recalls using documented SOPs, and we generate CAPA reports aligned with sponsor requirements and NAFDAC expectations.

Reconciliation, Returns & Destruction

At study closeout, we manage the reconciliation, return or certified destruction of unused IMPs in line with GDP and environmental regulations. Temperature excursions, product damage or deviations are investigated and documented as required.

Regional Reach & Strategic Advantage

With depots and distribution partners, Xcene Research offers reliable regional coverage supported by local regulatory insight. Our proximity to investigator sites reduces shipment lead times and ensures continuity even in remote or resourcelimited settings. GDP guidelines note that secure access controls and trained personnel are essential to prevent theft or tampering; our teams are trained accordingly and our facilities meet stringent security requirements.

Our Commitment

Xcene Research’s Drug Depot services combine operational precision, regulatory compliance and quality oversight to maintain product integrity from manufacturer to patient. We understand that drug distribution is not simply a logistical function, it is a commitment to patient safety and sponsor confidence. By adhering to global standards and local regulations, we ensure that every shipment maintains its quality, remains traceable and arrives on schedule.