Welcome to Medinel
Founded in 1996, Medinel Closed Corporation is a contract research organisation (CRO) dedicated to advancing product development through specialized services rooted in principles of ethics, safety and quality.
Services are tailored to meet the needs of each client’s needs, covering the spectrum of clinical research – from Phase I to Phase IV to compiling the Common Technical Document (CTD) and designing and implementing post-approval studies.
Dr. Annalene Nel, the founder, has been a leader in clinical research, ethics and GCP training since 1986. With extensive experience in establishing clinical trial units (CTU), leading CRO operations, and advancing a drug-device compound through Phase I-III to a positive EMA Article 58 opinion. Dr. Nel’s has guided various teams through successful FDA and EMA inspections at CTUs, CRO, and sponsor levels.
The Medinel team continues to strengthen clinical research capacity across sub-Saharan Africa. We provide cost-effective, high-quality services that align with international and local standards, managing and monitoring complex projects from Phase I-IV while emphasizing ethical standards, participant safety, quality data, and capacity-building.
Our Services
We are a specialised Contract Research Organisation, offering the following services:
Start-up
- Clinical Project Management
- Protocol and Essential Document Development
- Management Plans: Monitoring, Safety, Laboratory, and Investigational Product
- Site selection, pre-assessment, readiness and activation for Phase I – IV
- Monitoring
- Trial Master File (TMF) set-up and management
- Regulatory Authority (RA) and Institutional Review Board (IRB)/Ethics Committee (EC) process management
Conduct
- Site initiation and activation
- Investigational product (IP) management
- Monitoring incl. Investigator Site File
- Safety Monitoring
- Progress reports incl. RA and IRB/EC
- Quality Control incl. KPI, Corrective and Preventative action implementation (CAPA)
- Capacity strengthening
- Issue and Risk Management
- Addressing other trial-specific needs
Close-Out
- Site and Trial Close-out Activities
- IP reconciliation and destruction management
- Coordination of Archiving
- Medical Writing incl. Clinical Study Report
- RA and REC notification
- Unblinding and Result Dissemination Management
Safety Monitoring
- Clinical safety oversight
- Protocol deviation review and management
- Medical consultation
- AE listing review
Pharmacovigilance
- Serious Adverse Event (SAE) and other defined AE Reporting
- Signal Detection
- Risk Management
- Regulatory compliance
Safety Management Committee Management
- Data Safety Monitoring Board or equivalent set-up and management
GCP Audits on behalf of
- Pharmaceutical Sponsor
- Research Ethics Committee
- Contract Research Organisation
Systematic GCP Assessments
- Clinical Research Institution or Site Assessment
- Quality Management System Assessment
Audit or Inspection Readiness Assessment
- Clinical Research Sites
- Research Ethics Committee
Medinel’s ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
A key focus area is capacity building and strengthening of rural and urban clinical research site teams; therefore some training courses can be tailored accordingly. The aim is to empower research staff to successfully execute clinical research and trials to the highest global standards while taking care of the wellness and safety of trial participants.
GCP and Ethics in Health Research
- Basic introductory Ethics and GCP
- Advanced Ethics and GCP
- Refresher Ethics and GCP
- Ethics and GCP for the Sponsor
Quality Management
- Organisational Quality Management
- Clinical Quality Management
- Internal Quality Control
Other
- Principal Investigator Role and Responsibilities
- Good Participatory Practice including Community Engagement and set-up of Community Advisory Groups (CAGs)
- GCP inspection readiness
- Therapeutic
- Operational
Services are rendered in compliance with global and local regulatory authority and ethical guidelines and adhere to Good Clinical Practice (GCP) standards. Services can range from planning, developing, and coordinating the protocol and/or clinical trial process from pre-start up until close-out with the clinical study report.
Sponsors and clients can benefit from the Medinel team’s expertise, as their extensive experience and proven track record allow them to anticipate and mitigate potential challenges and risks, ensuring projects are delivered on time and within budget.
Additional Services
- Strategic and Operational Consulting
- Project Management
- Medical Writing
- External Service Provider Management
- Quality Management System Assessment
Special Projects
The Medinel team was tasked by a not-for-profit institution to develop a rural clinical trial unit (CTU) in KwaZulu-Natal. In 2020, we conducted a feasibility and community acceptance evaluation. Our team supported the architectural layout, infrastructure development, and operational platform implementation, alongside the creation of standard operating procedures (SOPs) in collaboration with the CTU research team. Initially, we provided introductory GCP training to 100 field workers and administrative staff, and advanced GCP training to 50 CTU clinical research staff.
The CTU focuses on studying major public health concerns in the area, including HIV, TB, COVID-19, and non-communicable diseases. Selected for their first clinical trials in late 2021, the CTU began enrolling participants in early 2022 and is now globally recognized for its commitment to ethics, safety, and quality in clinical research.
The institution’s management remains dedicated to upholding ethics, participant safety and quality. In 2024, the Medinel team provided GCP refresher training to approximately 150 CTU staff members and advanced GCP training to around 75 research staff.
Special Projects
The Medinel team was tasked by a not-for-profit institution to develop a rural clinical trial unit (CTU) in KwaZulu-Natal. In 2020, we conducted a feasibility and community acceptance evaluation. Our team supported the architectural layout, infrastructure development, and operational platform implementation, alongside the creation of standard operating procedures (SOPs) in collaboration with the CTU research team. Initially, we provided introductory GCP training to 100 field workers and administrative staff, and advanced GCP training to 50 CTU clinical research staff.
The CTU focuses on studying major public health concerns in the area, including HIV, TB, COVID-19, and non-communicable diseases. Selected for their first clinical trials in late 2021, the CTU began enrolling participants in early 2022 and is now globally recognized for its commitment to ethics, safety, and quality in clinical research.
The institution’s management remains dedicated to upholding ethics, participant safety and quality. In 2024, the Medinel team provided GCP refresher training to approximately 150 CTU staff members and advanced GCP training to around 75 research staff.
Our Passion
At Medinel we are committed to advancing clinical product development with dedication to ethics, safety, and quality.
Our Vision
To be a trusted partner in clinical research, advancing innovation and improving healthcare outcomes.
Our Mission
Advancing health through ethical clinical research, ensuring quality, participant safety and cost efficiency.
Our Values
Upholding ethics, respect, excellence, accountability, teamwork, and client satisfaction.
Our Passion
At Medinel we are committed to advancing clinical product development with dedication to ethics, safety, and quality.
Our Vision
To be a trusted partner in clinical research, advancing innovation and improving healthcare outcomes.
Our Mission
Advancing health through ethical clinical research, ensuring quality, participant safety and cost efficiency.
Our Values
Upholding ethics, respect, excellence, accountability, teamwork, and client satisfaction.
