TCD provides flexible Project Management models in accordance with the size and complexity of the study and in line with sponsor needs. To date, we have provided project management support to roughly 164 projects.
TCD has supported 160 trials with regulatory activities to date. Roughly 50 of these applications were for vaccine studies across different indications. In addition, we have also supported Ethics Committee activities on almost 120 of the trials we have been involved with to date.
TCD’s auditors are internationally qualified and have conducted more than a hundred audits across Sub-Saharan Africa, Asia, South-America and Europe to date. Our internal audit competence has proved valuable in assessing both active and prospective research sites in Africa, in tandem with capacity-building initiatives.
To date, TCD personnel have been involved in providing monitoring activities to almost 200 projects involving a multitude of countries including 14 Sub Saharan African countries. TCD boasts an experienced team of monitors.
TCD has provided local medical monitoring services for several studies, including FIH (first in human), neonatal vaccine and HIV vaccine studies. The medical monitoring team is responsible for supporting the project with safety data review as well as review of clinical data associated with SAEs per sponsor specifications provided.
TCD has experience managing Pharmacovigilance activities for several large vaccine and therapeutic trials. SafetyBase which is a dedicated safety database developed by our eClinical Solutions division, is accessible to both CRO and sponsor personnel to ensure immediate access to current safety data at all times.
All Data Management practices and standards employed are compliant with relevant ICH Guidelines as well as the applicable EMA and FDA guidelines. Though TCD’s Data Management team has experience in supporting a wide variety of platforms, TCD’s in-house proprietary EDC, Nukleus®, remains our preferred solution.
Services provided include the review of and input into statistical section of clinical trial protocol, development and finalisation of Statistical Analysis Plan as well as developing the Clinical Study Report (CSR) in collaboration with other functions.
Our medical writing services include developing the protocol, Investigator’s Brochure, Informed Consent Forms, Patient Reported Outcomes, CSRs and manuscripts, as required.