Patient Recruitment
At Tiervlei Trial Centre, we pride ourselves on being a trusted partner for both sponsors and participants.
TTC recognizes the importance of patient recruitment in the ultimate success of a clinical trial. We have a multi-faceted approach to recruitment with a view to obtaining a representative population from different geographical areas, cultural and genetic backgrounds, socio-economic levels, and disease profiles.
Established Recruitment and Community Engagement Department: TTC has a dedicated team with proven expertise in recruitment and retention, underpinned by a robust, multi-purpose strategy that integrates community engagement, social media advertising and participant-focused initiatives.
Successful Community Outreach Initiatives: TTC has launched numerous outreach projects aimed at supporting underprivileged communities, fostering trust, and building lasting relationships.
Strong partnerships with key institutions: TTC has developed solid working relationships with the Department of Health and the Department of Education, founded on mutual trust and respect. These partnerships enable us to access a wide range of healthcare and educational facilities. We collaborate with local and private hospitals, GP Practices, Specialists, Clinics, and other facilities throughout the Western Cape.
Community and educational engagement: Our Community Engagement Department hosts and contributes to community outreach events to raise awareness about clinical trials and to promote health and well-being amongst health volunteers and disease state groups. We also provide training opportunities for healthcare and educational professionals aimed at improving patient safety and patient outcomes.
Study feasibility process
TTC understands the importance of accurate, complete, and timeous completion of clinical trial feasibility assessments. This includes research opportunities presented to us by Sponsors, CROs, universities and other parties involved in the development of new medicines. We have a dedicated department for the completion of clinical trial study feasibilities with a dedicated e-mail address feasibilities@ttctrials.co.za.
TTC procedure for feasibility assessment:
- The site will evaluate the protocol by considering: potential benefits/risks to patients, personnel, resources, impact on standard of care, procedural requirements, patient availability, and ease of implementation of the Clinical Trial.
- Should no protocol or IB be available, the site will assist the sponsor in generation of the essential clinical trial documents, including qualification of Investigational Product, study design, population selection criteria, sample size and data management.
- TTC has a historic base of more than 500 completed studies with study metrics like screen failure rate and retention rate for respective therapeutic areas, investigational products, and sponsors, which contributes to more accurate feasibility estimates.
Study Start-up Process
TTC focuses on participant safety and welfare through the conduct of quality participant clinical trials.
TTC modernises clinical trial practices in response to evolving technologies and methodologies to strengthen confidence in the integrity, reliability, and credibility of clinical research results.
TTC Quality Management is integrated into the clinical trial process from the outset.
Conduct of a Clinical Trial
TTC focuses on participant safety and welfare through the conduct of quality participant clinical trials.
TTC modernises clinical trial practices in response to evolving technologies and methodologies to strengthen confidence in the integrity, reliability, and credibility of clinical research results.
TTC Quality Management is integrated into the clinical trial process from the outset.
Remote Data Capturing
The collection of accurate data and prompt resolution of queries decreases the number of monitoring visits required, which in turn translates into substantial cost savings for the sponsor. Systems used are: Medidata RAVE, Oracle, PhaseFoward, InForm, Perceptive DataLabs, Medidata RAVE, IBM.
Electronic Participant Reported Outcomes
TTC is aware of the importance of participant-reported outcome data using electronic devices as these may be used to capture key study endpoints. Care is taken in training the participants, avoiding entry of personal information in the device and for the participant to use a password not known to staff members. Systems are in place to monitor participant completion compliance and the follow-up of alerts.
Investigators have access through study-specific porta to review off-site data acquired by participants. Systems used are: Viasys (Jaeger), AM 2+, AM 3+, Biomedical Systems and Trialmax portal.
e-CTMS, e-Source, CRIO
This platform encompasses the creation and storage of clinical trial data in electronic format through implementation of electronic Source (e-Source) and electronic Investigator Site File (e-Regulatory) functions. Integration of these functions with the following foundational Clinical Trial Management and Oversight functions is key to successful delivery of excellent quality clinical trials:
• Participant visit scheduling and resource planning
• Patient database hosting and recruitment management
• Integrated finance management
• Recruitment, operational and financial reporting
Choosing the appropriate e-Clinical software solution was a meticulous process for TTC. We undertook a comprehensive landscape analysis, carefully evaluating available options based on criteria such as feature sets, technical specifications, and security features to ensure compliance with required regulations, including ICH GCP E6 R2, 21 CFR Part 11, Annex 11, HIPAA, GDPR, and POPIA. Our analysis also assessed the likelihood of successful implementation and the long-term financial sustainability of candidate solutions.
CRIO’s Security and Compliance Features
Ensuring the integrity and confidentiality of our clinical data is a top priority, and CRIO met and exceeded our expectations in this regard with features such as:
• ISO 27001 and SOC 2 compliant Google Cloud Platform data centres located around the globe ensuring Personal Health Information is kept in line with local requirements.
• Continuous data back-up with point-in-time recovery and zero Recovery Point Objective
• Data encryption in transit and at rest
• 99.9% uptime recorded since the company was founded in 2015
• Seamless deployment with no scheduled downtime
• Regularly scheduled third-party penetration testing
• Multi-Factor Authentication (MFA)
• Access to required validation and controlled documents in CRIO’s document centre
• 100% FDA audit record of accomplishment.
• Externally validated regulatory compliance audits.
TTC Participant Database
Housed within the world class CRIO eCTMS, TTC boasts a database of [+2000] potential participants. Participants have traits acquired during recruitment and trail procedures which then carry over to subsequent studies when they are recruited/enrolled. These traits enable TTC to select and recruit patients for several therapeutic areas with a multitude of selection/enrolment criteria. The integrated systems in CRIO allow seamless tracking of participants within studies and during recruitment, with automatic logging of interactions and intuitive tracking of status throughout their journey with us at TTC. All this ensures quality care is given to quality participants with good clinical practice (GCP) at the forefront of recruitment operations.
Enhanced Data Governance
With the increasing reliance on digital technologies in clinical trials, ICH E6 R3 places a stronger emphasis on data integrity and security. This includes stricter protocols for data handling, ensuring accuracy and traceability, and adopting advanced data management practices to protect confidentiality.
With the increasing reliance on digital technologies in clinical trials, ICH E6 R3 places a stronger emphasis on data integrity and security. This includes stricter protocols for data handling, ensuring accuracy and traceability, and adopting advanced data management practices to protect confidentiality.
Integration of Technology
As part of our compliance with the latest ICH GCP regulations and guidelines, we integrate modern technologies into our clinical trials, including electronic health records (EHR) and electronic Clinical Trial Management Systems (e-CTMS). We adopt a media-neutral approach that ensures flexibility in data collection and management, allowing us to tailor processes to meet participant needs and the specific requirements of each trial.
Interactive Voice Response Systems
The following systems are used for registering study visits and allocation of treatments to participants: ClinPhone, Almac, RAMOS, i-Perspective, ICON, and IMPALA.
Regulatory Submissions
Tiervlei Trial Centre has a dedicated team specialising in clinical trial submissions to regulatory authorities. Our experienced professionals ensure that all submissions are meticulously prepared, meeting specific requirements of regulatory bodies while adhering to strict timelines.
Key highlights of our regulatory submission process:
- Accuracy and compliance: Every submission is crafted with precision to comply fully with regulatory standards and guidelines.
- Timely delivery: Our team is committed to meeting deadlines to avoid any delays in trial initiation and progression.
- Comprehensive knowledge: With a deep understanding of regulatory processes and expectations, we provide seamless and efficient management of all submission-related tasks.
Contract and Budget Review
Special Investigations
Lung function tests, allergen skin prick tests and bronchial provocation tests are performed by qualified clinical technologists. Measurements of blood pressure, pulse, blood glucose, lipid profile, HbA1C, and oxygen saturation are done by professional nurses. ECG, echocardiography, carotid ultrasound cardiac rhythm monitoring, radiology and CT scan are done on site by specialists. Bone density scans can be arranged off-site.
Medical Writing
TTC provides a professional medical writing service. Our team has extensive experience in Protocol and Statistical Report Writing, Patient informed Consent Forms, Diary Cards, and Case Report Forms. TTC contracts the services of experienced statisticians and specialists that offer expertise in therapeutic areas and pharmacokinetics.
Specialist Consultation
TTC plays a pivotal role in providing specialised consultation services to trial participants, ensuring their well-being, informed consent, and optimal engagement throughout the trial process. These services extend beyond the basic requirements of the trial protocol, focusing on addressing participants’ individual concerns, optimising their understanding of the trial, and monitoring their health closely.
Firstly, TTC offers expert consultations to educate participants about the trial’s purpose, potential risks and benefits, and the procedures involved. This fosters a transparent and informed consent process, empowering participants to make educated decisions about their involvement.
Throughout the trial, specialised consultations are essential for monitoring participants’ health, managing any side effects, and promptly addressing questions or concerns. This personalised care enhances participant retention, compliance, and overall satisfaction with the trial experience.
Also, TTC provides ongoing support for participants involving educational materials and access to a multidisciplinary team of healthcare professionals.
The specialist consultation services offered by TTC prioritise the holistic well-being of trial participants, ensuring that their experience is not only scientifically rigorous but also ethically sound and supportive of individual health needs.
Collaboration with Universities
The collaboration between TTC and educational institutions is a symbiotic relationship that significantly advances both medical research and academic pursuits. Educational institutions, such as universities and medical schools, provide a rich source of intellectual capital, bringing together researchers, clinicians, and students who contribute diverse perspectives and skills to clinical trials.
Partnerships with educational institutions enhance the clinical trial centre’s access to innovative research methodologies, scientific expertise, and the latest advancements in medical knowledge. This collaboration often extends beyond the trial phase, fostering a continuous loop of learning, where findings from trials contribute to curriculum development and inform future research endeavours.
The involvement of educational institutions in clinical trials encourages the training of the next generation of healthcare professionals and researchers. It creates a dynamic environment that nurtures innovation, critical thinking, and interdisciplinary collaboration. As a result, this partnership not only accelerates the pace of medical discovery but also contributes to the cultivation of a well-rounded and skilled clinical workforce poised to address the evolving challenges in healthcare and research.
Collaboration with Government Hospitals
The collaboration between Tiervlei Trial Centre and neighbouring public healthcare institutions represents a vital constructive collaboration in advancing medical research and enhancing healthcare outcomes. Clinical trials performed at TTC are essential for evaluating the safety and efficacy of new treatments, drugs, or medical interventions, and state hospitals serve as crucial hubs for patient recruitment and data collection.
State hospitals offer a diverse patient population, ensuring that clinical trials reflect South African real-world scenarios and provide insights into how different demographic groups respond to treatments. Additionally, these hospitals contribute valuable infrastructure and expertise, facilitating the smooth implementation of trials. Collaborating with TTC allows state hospitals to engage in innovative research, staying abreast of the latest medical advancements and improving patient care through evidence-based practices.
This partnership also fosters a two-way exchange of knowledge. State hospitals benefit from the specialised research skills and resources of TTC’s highly qualified clinical team, while the centre gains access to a broader patient pool and the nuanced challenges of public healthcare settings.
This collaboration strengthens the translational impact of research, bringing innovative therapies from the laboratory to the bedside, and improving health outcomes for the broader community.
Training & Development
TTC is actively involved in several educational programs. We present the Clinical Investigator and Site Staff Certification (CLIC) course, in partnership with FUNDISA AFRICAN ACADEMY for MEDICINE DEVELOPMENT and support the Postgraduate Diploma in Medicines Development, presented by the Division of Pharmacology, University of Stellenbosch. TTC is a Health Professional Council of South Africa-approved training site for Clinical Pharmacology registrars from the University of Stellenbosch.
Product Research
Investors