When We Accelerate
Medical Discovery
We are a trusted and responsive Contract Research Organisation (CRO), specialising in data management services, clinical trial project management, monitoring services and collaborations with regional academic partners. We give funders, sponsors and clinical researchers the confidence needed to advance medical discoveries. 
At BioInformatiCo, we work with cutting-edge scientists, researchers, study leads and project sponsors who are asking the big questions needed to further the advancement of science and clinical therapies.
We believe that data integrity and insight creates the confidence needed for clinical trial research teams to think and act strategically. But beyond the data, what really sets us apart is our mastery of the research context.
At BioInformatiCo, we work with cutting-edge scientists, researchers, study leads and project sponsors who are asking the big questions needed to further the advancement of science and clinical therapies.
We believe that data integrity and insight creates the confidence needed for clinical trial research teams to think and act strategically. But beyond the data, what really sets us apart is our mastery of the research context.
We are an organically grown
South African public-private
collaboration.
Our footprint extends
throughout Sub-Saharan
Africa
We are committed to capacity
development in South Africa
and beyond.
We are an organically grown
South African public-private
collaboration.
Our footprint extends
throughout Sub-Saharan
Africa
We are committed to capacity
development in South Africa
and beyond.
We offer a range of data management and other related services tailored to meet the diverse needs of our clients.
We provide operational reporting aimed at enhancing enrolment, retention, visit window compliance and protocol adherence, along...
Value-Added Reporting for Study OptimisationWe provide operational reporting aimed at enhancing enrolment, retention, visit window compliance and protocol adherence, along with comprehensive participant safety reports. Leveraging our validated reporting platform, we deliver automated, up-to-date reports featuring sophisticated statistical visualisations, empowering your study team with actionable insights to improve the quality of the clinical data.
Our expertise extends to seamless integration withyour existing product suite, all while maintaining strict regulatory...
Validated Customised IntegrationsOur expertise extends to seamless integration with your existing product suite, all while maintaining strict regulatory compliance with standards such as 21 CFR Part 11, GxP, ICH E6 (R2), ISO27001 and SOC2.
Our dedicated clinical team stands ready to address any safety concerns or symptoms encountered by trial participants, providing...
Dedicated Safety Reporting DeskOur dedicated clinical team stands ready to address any safety concerns or symptoms encountered by trial participants, providing swift and effective support whenever needed.
We specialise in the implementation and management of safety databases, offering comprehensive safety reporting support thr...
Drug Safety and Pharmacovigilance ServicesWe specialise in the implementation and management of safety databases, offering comprehensive safety reporting support throughout the trial duration. Our capabilities encompass early signal detection, safety reports and proactive management of clinical safety issues.
Our expert team excels in authoring sample size calculations, randomisation plans and statistical analysis plans, ensuring the integ....
Biostatistical ExpertiseLeveraging advanced biostatistical and epidemiological methods, we offer invaluable insights into data generated by ...
Real-World Data InsightsLeveraging advanced biostatistical and epidemiological methods, we offer invaluable insights into data generated by healthcare funders. Our expertise enables us to evaluate real-world effectiveness and conduct post-marketing surveillance, empowering you to make informed decisions throughout the product lifecycle.
We have medical doctors and Clinical Study Report (CSR) specialists who can author appropriate documents, including CSRs.
Medical Writing and Report PublishingWe oversee every stage of your data journey, starting from the initiation of the study to its final submission.
Comprehensive Clinical Data Management SolutionsWe oversee every stage of your data journey, starting from the initiation of the study to its final submission. Our services encompass electronic Case Report Form (eCRF) design, intuitive form display logic, robust database design and setup, efficient query management and insightful report listings. Collaborating closely with clinical teams, we ensure that your trial progresses seamlessly, adhering to set timelines and objectives.
We provide operational reporting aimed at enhancing enrolment, retention, visit window compliance and protocol adherence, along…
Value-Added Reporting for Study OptimisationWe provide operational reporting aimed at enhancing enrolment, retention, visit window compliance and protocol adherence, along with comprehensive participant safety reports. Leveraging our validated reporting platform, we deliver automated, up-to-date reports featuring sophisticated statistical visualisations, empowering your study team with actionable insights to improve the quality of the clinical data.
Our expertise extends to seamless integration withyour existing product suite, all while maintaining strict regulatory…
Validated Customised IntegrationsOur expertise extends to seamless integration with your existing product suite, all while maintaining strict regulatory compliance with standards such as 21 CFR Part 11, GxP, ICH E6 (R2), ISO27001 and SOC2.
Our dedicated clinical team stands ready to address any safety concerns or symptoms encountered by trial participants, providing…
Dedicated Safety Reporting DeskOur dedicated clinical team stands ready to address any safety concerns or symptoms encountered by trial participants, providing swift and effective support whenever needed.
We specialise in the implementation and management of safety databases, offering comprehensive safety reporting support thr…
Drug Safety and Pharmacovigilance ServicesWe specialise in the implementation and management of safety databases, offering comprehensive safety reporting support throughout the trial duration. Our capabilities encompass early signal detection, safety reports and proactive management of clinical safety issues.
Our expert team excels in authoring sample size calculations, randomisation plans and statistical analysis plans, ensuring the integ….
Biostatistical ExpertiseOur expert team excels in authoring sample size calculations, randomisation plans and statistical analysis plans, ensuring the integrity and rigor of your study design and analysis.
Leveraging advanced biostatistical and epidemiological methods, we offer invaluable insights into data generated by …
Real-World Data InsightsLeveraging advanced biostatistical and epidemiological methods, we offer invaluable insights into data generated by healthcare funders. Our expertise enables us to evaluate real-world effectiveness and conduct post-marketing surveillance, empowering you to make informed decisions throughout the product lifecycle.
We have medical doctors and Clinical Study Report (CSR) specialists who can author appropriate documents, including CSRs.
Medical Writing and Report PublishingWe have medical doctors and Clinical Study Report (CSR) specialists who can author appropriate documents, including CSRs.
BioInformatiCo offers comprehensive Clinical Trial Project Management services to ensure the seamless execution…
Clinical Trial Project ManagementBioInformatiCo offers comprehensive Clinical Trial Project Management services to ensure the seamless execution of clinical studies. Our experienced project managers oversee the entire trial lifecycle, from initiation to closeout, ensuring adherence to regulatory requirements, timelines, and budgets. We coordinate with sponsors, sites, and stakeholders to manage study timelines, milestones, risk mitigation, resource allocation, and compliance with Good Clinical Practice (GCP). Our structured approach enhances efficiency, minimises risks, and ensures high-quality data collection to support regulatory submissions.
Our Medical Monitoring service provides real-time oversight of clinical trial data to safeguard participant safety and…
Medical MonitoringOur Medical Monitoring service provides real-time oversight of clinical trial data to safeguard participant safety and ensure data integrity. Led by experienced medical professionals, we conduct medical review of adverse events, protocol deviations, and safety signals, working proactively to mitigate risks. We collaborate closely with investigators and regulatory bodies to ensure protocol adherence, ethical compliance, and high-quality clinical outcomes. BioInformatiCo’s medical monitoring services help sponsors maintain study integrity while prioritising patient safety.
We believe that data integrity and insight creates the confidence needed for clinical trial research teams to think and act strategically.
At the core of our team are skilled and passionate industry professionals. This includes clinicians who understand the clinical context and developers who set up your database correctly right from the start. Our multidisciplinary expertise provides a smooth and efficient overall experience.
We understand that partnering and collaborating with active sponsors and Clinical Research Organisations (CROs) is fundamental to our mutual success. This collaborative spirit and dedication to excellence is how we define real partnership, and it’s what we bring to every project that we are involved in.
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