Study feasibility process. TTC has a department for completion of study feasibility assessments within a reasonable time frame. We have detailed information on each completed study since 2000 including: name of principal investigator, therapeutic area, screen failure rates, randomization and retention rates, for respective sponsors and CROs.
Clinical Trials. TTC aims to address the needs of the sponsor in completing clinical trials timeously and meeting the target number of participants required for each study protocol. TTC has participated in studies in a wide range of therapeutic areas and in all phases of development. The majority of studies are late phase (75%) and in adults. Since 2015 we have extended our service to conduct pediatric clinical trials, as there is a requirement for data in children prior to registration of new medicines through the Pediatric Investigational Plan (PIP).
Early Phase. TTC is experienced in the conduct of early phase studies (25% of studies conducted), and have a special facility for the performance of pharmacokinetic and bioequivalence studies.
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: Medidata RAVE, Oracle, PhaseFoward i.e. InForm, Perceptive i.e. DataLabs, Datarak, RACE.
Patient Electronic Diaries. Great care is taken in training of participants to use electronic diaries. Investigators have access through a portal to review off-site data acquired by participants. Systems used: Viasys (Jaeger), AM 2+, AM 3+, Biomedical Systems, Blackberry and Trialmax portal.
Electronic Data Transfer. TTC has the capability to transmit electronic data using a dedicated analog line. We have experience in: Mortara Electrocardiogram Transfers, Medilog Holter transfers, MAC 1200, Viasys Spirometry, ECG and electronic diary data.
Interactive Voice Response Systems. The following systems are used for registering of study visits and allocation of treatments to participants: ClinPhone, Almac, RAMOS, i-Perspective, ICON, IMPALA.
Focus on Good Clinical Practice and Patient Education. Investigators knowledgeable in GCP and the disease under investigation are responsible for education of the participants on their condition as well as for the Informed Consent Process. The trial centre is a friendly environment, where the wellbeing of participants is paramount.
Regulatory Submissions. TTC has a team specializing in Clinical Trial submission to Regulatory Authorities. The submissions are completed accurately according to requirements and within timelines.
Contract and Budget review. TTC has a department for the negotiation of budget and clinical study agreements. The review time is maximum 2 weeks.
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 of obtaining a representative population from different geographical areas, cultural and genetic backgrounds as well as socio-economic standards and diseases profiles. We currently have a well-established database of available patients and healthy volunteers. TTC has access to Karl Bremer Hospital’s in- and out-patients as well as day clinics. We have obtained approval from local governmental bodies for recruitment from peripheral day hospitals. A large proportion of our patients are recruited by “word-of-mouth”. We actively advertise in newspapers and have made use of advertorials. Social media is the latest tool for communicating with potential participants and patients. We have made use of local radio stations with success. Wellness meetings with patient education and shopping centre visits are done. In collaboration with a sponsor and a patients advocacy group, a camp for education of diabetic children has been arranged, where we will educate patients and introduce them to our studies.
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.
The TTC team provides specialist consultation to clinical trial participants. We work in collaboration with specialists in the private sector and local universities. Meet Our Team
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 services of experienced statisticians and specialists that offer expertise in therapeutic areas and pharmacokinetics.
TTC provides a specialised clinical trial services to local Universities ranging from review of data on investigational medicines prior to clinical trial, protocol writing, regulatory service and conduct of clinical trials through to writing of clinical trial reports.
TTC recognizes the challenge facing the South African health system and provides equitable distribution of resources between the public and private health care sectors. We support the Karl Bremer Hospital by providing special medical services free of charge, supply medication to patients for extended periods, motivate hospital staff through contributing to staff “Awards of Excellence” and support the system where needed.