Course Introduction
Clinical research is fundamental to advancing medical knowledge, evaluating new treatments, improving patient outcomes, and strengthening evidence-based healthcare. However, clinical research projects operate within complex scientific, ethical, regulatory, operational, and financial environments that require rigorous planning and disciplined management. Challenges such as delayed regulatory approvals, slow participant recruitment, protocol deviations, insufficient site capacity, budget overruns, data quality issues, and inconsistent stakeholder coordination can compromise study timelines, research integrity, and the reliability of findings. This course provides a comprehensive framework for planning, managing, monitoring, and closing clinical research projects while maintaining scientific quality, participant safety, regulatory compliance, and operational efficiency.
The programme examines the complete clinical research project lifecycle, from research concept development and feasibility assessment through protocol planning, regulatory submissions, site activation, participant recruitment, study implementation, data management, analysis, reporting, and closeout. Participants will learn how to translate clinical research objectives into structured work plans, realistic timelines, resource estimates, staffing requirements, operational procedures, and measurable milestones. The course addresses the practical differences between clinical trials, observational studies, diagnostic research, investigator-initiated studies, and other clinical research designs, emphasizing the importance of matching project management methods to study complexity, risk, population characteristics, and regulatory requirements.
A major focus is placed on clinical trial governance, Good Clinical Practice (GCP), research ethics, and participant protection. Participants will examine the responsibilities of sponsors, principal investigators, clinical research coordinators, contract research organizations, ethics committees, regulatory authorities, and institutional research offices. The programme explores informed consent, participant eligibility, safety reporting, protocol compliance, investigational product accountability where applicable, essential documentation, and oversight of clinical research sites. It also addresses risk-based quality management, monitoring strategies, inspection readiness, deviations, corrective and preventive actions, and the documentation standards required to demonstrate that research is conducted ethically, consistently, and in accordance with applicable requirements.
Effective clinical research management also requires strong financial planning, resource coordination, vendor oversight, and operational control. The course explores clinical research budgeting, site payments, laboratory services, diagnostic procedures, investigational products, equipment, insurance, participant reimbursement, data management, monitoring, and regulatory costs. Participants will learn to develop realistic study budgets, cash-flow forecasts, procurement plans, staffing models, and resource allocation strategies. Particular attention is given to managing multicentre studies, cross-border research, contract research organizations, specialist laboratories, technology vendors, and collaborating institutions while maintaining transparent financial controls, clear contractual responsibilities, and reliable communication across distributed research teams.
The programme integrates advanced project monitoring, clinical data management, risk assessment, and performance assurance. Participants will learn to track recruitment and retention, site activation, protocol compliance, data completeness, query resolution, safety reporting, milestone achievement, expenditure, and study completion forecasts. The course examines critical path scheduling, risk registers, recruitment forecasting, performance dashboards, deviation management, and corrective action planning. It also addresses common delivery challenges, including competing clinical workloads, participant withdrawal, supply interruptions, unexpected safety signals, data inconsistencies, staffing turnover, and amendments to study protocols. Through structured oversight and evidence-based decision-making, participants will learn to identify emerging problems early and implement proportionate responses without compromising participant welfare or scientific validity.
The course incorporates evolving clinical research technologies and modern data governance practices, including electronic data capture, electronic trial master files, clinical trial management systems, remote and decentralized study approaches, wearable devices, digital consent, and AI-assisted research operations. Participants will examine the appropriate use of automation, advanced analytics, and artificial intelligence in feasibility assessment, recruitment planning, data quality monitoring, risk prediction, and reporting. The programme also addresses cybersecurity, privacy, data integrity, software validation, responsible AI, and human oversight. Through practical case studies, study planning exercises, budget simulations, risk assessments, and clinical research management scenarios, participants will develop the capabilities to coordinate complex clinical studies, improve operational performance, strengthen regulatory readiness, and deliver reliable research outcomes while protecting the rights, safety, and well-being of participants.
Duration
10 days
Who Should Attend
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Clinical research project managers responsible for planning, coordinating, implementing, and closing clinical studies.
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Principal investigators and co-investigators overseeing clinical trials, investigator-initiated studies, and other clinical research projects.
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Clinical research coordinators managing participant recruitment, study visits, site operations, documentation, and protocol compliance.
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Clinical trial managers responsible for study timelines, operational delivery, cross-functional coordination, and performance monitoring.
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Clinical research associates and monitors conducting site monitoring, source data verification where applicable, and compliance oversight.
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Clinical research administrators managing study approvals, contracts, documentation, budgets, and institutional research processes.
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Sponsor representatives and clinical operations professionals overseeing clinical development programmes and trial delivery.
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Contract research organization professionals coordinating outsourced clinical research activities and vendor performance.
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Research nurses, study nurses, and healthcare professionals supporting participant screening, consent, study procedures, and follow-up.
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Data managers and biostatistics professionals supporting clinical data quality, database management, statistical planning, and analysis.
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Pharmacovigilance and clinical safety professionals managing adverse event reporting, safety oversight, and risk escalation.
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Regulatory affairs specialists responsible for clinical trial applications, amendments, regulatory correspondence, and compliance requirements.
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Ethics committee and institutional review board professionals involved in ethical review, participant protection, and continuing oversight.
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Clinical laboratory and investigational product professionals managing sample processing, laboratory quality, product accountability, and supply coordination.
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Quality assurance and compliance professionals conducting clinical research audits, quality reviews, and corrective action follow-up.
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Clinical research finance and grants officers responsible for study budgets, site payments, expenditure monitoring, and financial reporting.
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Digital health and clinical research technology professionals supporting electronic systems, remote studies, and data governance.
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Public health researchers and academic investigators managing clinical or health-related research projects.
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Research programme directors and institutional leaders overseeing clinical research portfolios and operational performance.
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Professionals seeking to strengthen their practical capabilities in clinical study planning, trial management, quality assurance, and regulatory compliance.
Course Objectives
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Develop advanced knowledge of clinical research project management, including study planning, regulatory coordination, operational delivery, quality oversight, and closeout.
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Translate clinical research questions and protocols into realistic work breakdown structures, schedules, resource plans, milestones, and delivery responsibilities.
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Assess clinical study feasibility by evaluating participant availability, site capacity, recruitment assumptions, operational complexity, infrastructure, and regulatory requirements.
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Develop comprehensive clinical research budgets, cash-flow forecasts, staffing plans, procurement schedules, and financial control arrangements.
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Apply Good Clinical Practice principles, ethical requirements, informed consent procedures, and participant protection measures throughout the research lifecycle.
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Establish effective study governance, sponsor-investigator responsibilities, site oversight, vendor management, communication arrangements, and escalation procedures.
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Implement risk-based quality management, monitoring strategies, protocol deviation controls, essential documentation practices, and inspection readiness procedures.
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Manage participant recruitment, retention, study visits, site activation, clinical supplies, laboratory activities, and cross-functional operational dependencies.
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Apply clinical data management, data quality assurance, safety reporting, performance monitoring, and evidence-based corrective action techniques.
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Strengthen compliance with applicable regulatory requirements, research ethics approvals, privacy obligations, data integrity standards, and institutional policies.
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Use clinical trial management systems, electronic data capture, analytics, automation, and AI-assisted tools responsibly to improve operational efficiency and oversight.
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Develop effective study closeout, final reporting, data archiving, lessons-learned, and continuous improvement strategies that strengthen future clinical research performance.
Comprehensive Course Outline
Module 1: Foundations of Clinical Research Project Management
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Principles of clinical research management, scientific integrity, participant protection, operational coordination, and reliable evidence generation.
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Overview of clinical trials, observational studies, diagnostic studies, investigator-initiated research, and other clinical research designs.
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Roles and responsibilities of sponsors, principal investigators, research coordinators, monitors, ethics committees, regulators, and service providers.
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Clinical research lifecycle management covering concept development, feasibility, approvals, site activation, implementation, analysis, and closeout.
Module 2: Clinical Study Design, Feasibility and Protocol Planning
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Assessment of research questions, study objectives, endpoints, participant populations, methodological requirements, and operational feasibility.
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Translation of approved protocol requirements into activities, work packages, milestones, responsibilities, and implementation schedules.
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Evaluation of site capabilities, participant access, equipment, laboratory services, staffing, infrastructure, and recruitment assumptions.
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Identification of operational constraints, design dependencies, protocol complexity, and implementation risks before study initiation.
Module 3: Clinical Research Scheduling and Resource Management
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Development of integrated study schedules covering approvals, site initiation, recruitment, treatment or observation periods, follow-up, and closeout.
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Application of critical path analysis, milestone tracking, dependency mapping, resource loading, and schedule forecasting for clinical studies.
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Planning of research personnel, clinical facilities, laboratory capacity, specialist services, equipment, and study-related supplies.
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Management of timeline deviations, competing clinical workloads, staff turnover, delayed approvals, and schedule recovery requirements.
Module 4: Clinical Research Budgeting and Financial Management
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Preparation of study budgets covering personnel, site payments, laboratory testing, diagnostics, participant reimbursement, monitoring, and data management.
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Estimation of start-up costs, per-participant costs, fixed expenses, vendor fees, regulatory costs, insurance, and closeout requirements.
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Development of cash-flow forecasts, site payment schedules, expenditure controls, cost allocation procedures, and budget variance reports.
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Management of funding restrictions, contract amendments, unanticipated costs, foreign exchange exposure, and financial reporting obligations.
Module 5: Regulatory Approvals, Ethics and Good Clinical Practice
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Application of Good Clinical Practice principles and relevant national regulatory requirements to clinical research planning and delivery.
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Preparation and coordination of ethics submissions, regulatory applications, informed consent materials, and required institutional approvals.
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Management of continuing review, protocol amendments, safety notifications, approval conditions, and regulatory correspondence.
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Establishment of compliance registers, training records, essential documentation, audit trails, and inspection readiness procedures.
Module 6: Site Selection, Activation and Investigator Oversight
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Development of site selection criteria covering investigator qualifications, patient access, infrastructure, staffing, facilities, and prior performance.
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Coordination of site feasibility assessments, contracts, regulatory documentation, training, initiation visits, and activation requirements.
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Establishment of investigator responsibilities, delegation logs, communication protocols, site performance indicators, and oversight arrangements.
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Management of site underperformance, delayed activation, resource constraints, staff changes, and corrective action requirements.
Module 7: Participant Recruitment, Consent and Retention Management
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Development of recruitment plans using realistic eligibility assumptions, referral pathways, site capacity, and participant engagement strategies.
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Management of screening, eligibility verification, informed consent, enrolment documentation, participant scheduling, and follow-up procedures.
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Implementation of ethical recruitment and retention approaches that respect participant autonomy, confidentiality, and equitable access.
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Monitoring of recruitment rates, screen failures, withdrawals, missed visits, retention trends, and corrective actions to address underperformance.
Module 8: Clinical Operations, Investigational Products and Vendor Management
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Coordination of clinical procedures, study visits, laboratory testing, sample collection, diagnostic services, and other protocol-defined activities.
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Management of investigational product procurement, storage, distribution, accountability, temperature monitoring, and disposal where applicable.
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Oversight of contract research organizations, central laboratories, imaging providers, logistics companies, and specialist technology vendors.
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Application of supplier qualification, service agreements, delivery milestones, quality requirements, and escalation procedures for operational disruptions.
Module 9: Clinical Data Management and Research Information Systems
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Development of data management plans covering case report forms, database specifications, data entry, validation checks, and database lock requirements.
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Application of electronic data capture, clinical trial management systems, electronic trial master files, and secure study documentation platforms.
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Management of data queries, source documentation, missing data, reconciliation, audit trails, access permissions, and data integrity controls.
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Coordination of statistical programming, coding standards where applicable, data transfer specifications, and analysis-ready dataset preparation.
Module 10: Safety Monitoring, Quality Assurance and Protocol Compliance
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Management of adverse events, serious adverse events, safety escalation, reporting timelines, and applicable pharmacovigilance obligations.
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Implementation of risk-based monitoring, quality tolerance limits, critical-to-quality assessments, and targeted oversight activities.
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Identification, documentation, investigation, and resolution of protocol deviations, noncompliance, data inconsistencies, and quality issues.
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Development of corrective and preventive action plans, quality reviews, audit preparation, and inspection response procedures.
Module 11: Clinical Research Risk Management and Change Control
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Identification of scientific, operational, recruitment, regulatory, financial, data security, supplier, and participant safety risks.
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Development of risk registers, probability and impact assessments, mitigation measures, risk ownership, and escalation thresholds.
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Management of protocol amendments, changes in study assumptions, delayed milestones, budget pressure, supply interruptions, and staffing disruptions.
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Application of contingency planning, impact assessment, change approval, reforecasting, and recovery strategies to protect study quality and timelines.
Module 12: Multicentre and International Clinical Study Management
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Establishment of governance arrangements, coordination structures, reporting standards, and communication routines for multicentre studies.
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Management of investigator sites, regional research teams, contract partners, central laboratories, and shared operational dependencies.
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Coordination of cross-border regulatory requirements, ethics approvals, contracts, data transfers, specimen movements, and local operating procedures.
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Oversight of site consistency, performance variation, protocol compliance, documentation standards, and consolidated study reporting.
Module 13: Digital, Decentralized and AI-Enabled Clinical Research
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Application of electronic consent, telehealth visits, remote monitoring, wearable devices, digital endpoints, and decentralized study approaches.
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Use of AI-assisted feasibility assessment, recruitment forecasting, data quality surveillance, document review, and operational risk identification.
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Integration of automation, digital workflows, dashboards, and predictive analytics into clinical research coordination and oversight.
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Management of cybersecurity, software validation, privacy, digital exclusion, responsible AI, human oversight, and system auditability.
Module 14: Clinical Research Data Protection, Ethics and Research Integrity
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Application of privacy and confidentiality requirements to participant records, clinical datasets, biological samples, and research documentation.
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Management of access controls, secure data storage, data sharing agreements, retention schedules, and appropriate secondary data use.
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Prevention and management of research misconduct, conflicts of interest, unauthorized disclosure, inappropriate authorship, and data manipulation.
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Establishment of incident reporting, research integrity investigations, ethics escalation, and documented corrective action procedures.
Module 15: Clinical Study Performance Monitoring, Reporting and Analysis
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Development of study dashboards and indicators covering recruitment, site activation, retention, data completeness, safety reporting, and milestones.
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Application of budget variance analysis, expenditure forecasting, timeline tracking, resource utilization, and completion date projections.
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Preparation of progress reports, sponsor updates, funder reports, safety summaries, and documented management decisions.
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Assessment of operational performance, study quality, data readiness, delivery risks, and opportunities for continuous improvement.
Module 16: Clinical Research Closeout, Dissemination and Strategic Improvement
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Planning of site closeout, outstanding data resolution, investigational product reconciliation, final documentation, and contractual closure.
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Coordination of database lock, statistical analysis readiness, final study reports, results disclosure, and applicable registry updates.
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Management of essential record archiving, retention requirements, publication planning, data access, and institutional handover responsibilities.
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Development of lessons-learned reviews, study performance evaluations, process improvement plans, and recommendations for future clinical research programmes.
Training Approach
This course will be delivered by our skilled trainers who have vast knowledge and experience as expert professionals in the fields. The course is taught in English and through a mix of theory, practical activities, group discussion and case studies. Course manuals and additional training materials will be provided to the participants upon completion of the training.
Tailor-Made Course
This course can also be tailor-made to meet organization requirement. For further inquiries, please contact us on: Email: training@upskilldevelopment.com Tel: +254 721 331 808
Training Venue
The training will be held at our Upskill Training Centre. We also offer training for a group (at a discount of 10% to 50%) at requested location all over the world. The Onsite course fee covers the course tuition, training materials, two break refreshments, buffet lunch, airport transfers, Upskill gift package, and guided tour.
Visa application, travel expenses, dinners, accommodation, insurance, and other personal expenses are catered by the participant
Certification
Participants will be issued with Upskill certificate upon completion of this course.
Airport Pickup and Accommodation
Airport pickup and accommodation is arranged upon request. For booking contact our Training Coordinator through Email: training@upskilldevelopment.com, +254 721 331 808
Terms of Payment:
Unless otherwise agreed between the two parties’ payment of the course fee should be done 3 working days before commencement of the training so as to enable us to prepare better.
