ABOUT US
BioInformatiCo is a Proudly South African Company
We emerged as a result of a strategic public-private collaboration forged with the South African Medical Research Council (SAMRC) amidst the challenging backdrop of the COVID-19 pandemic.
BioInformatiCo is the appointed data management service provider for CoVPN3008 and CoVPN3008 TB sub study.
We are delighted to support the NIH-funded HIV Vaccine Trials Network (HVTN), which was established to address the pressing need for HIV vaccines.
Our expertise encompasses the development of robust data quality processes for electronic Case Report Form (eCRF), data capture, clinical coding as well as the implementation of efficient data management and reconciliation processes, expediting real-time data quality improvement.
We create mobile friendly app-based data visualisation, bulk reporting and customised strategic leadership reports to ensure that data is always insight-ready and actionable.
We partner with study teams from protocol creation to understand the scientific questions being asked and implications for the data being collected. To assist in managing the data, we deliver customised electronic database design and set-up for ease of use, intelligent feedback and event alerts.
Why choose
BioInformatiCo
Why choose BioInformatiCo
Why choose BioInformatiCo
Large phase 3 Safety and Efficacy study
We completed the mid-study data transfer of a large phase 3 Safety and Efficacy study conducted in 42 sites in Africa with more than 14 000 participants.
Established Success
Executed large phase 3 safety and efficacy study, launched 6,000-person study for NIH-funded HVTN, data management for Phase vaccine trial. Exceptional Delivery
Rescued data management services mid-study at 30% of monthly ongoing cost for multi-country vaccine trial with 47 sites. 18 years healthcare analysis experienceWe are founder-led by a healthcare actuary with 18 years healthcare analysis experience. Shirley Collie has collaborated in academic studies with leading researchers and has published in high impact journals such as The Lancet, NEJM and BMJ. Her deep understanding of administrative healthcare data and epidemiological analytic concepts benefits BioInformatiCo’s reporting to add value to study-teams.Research clinicians with investigator experienceOur data management team includes research clinicians with investigator experience in clinical trial conduct because we know our sponsors and partners appreciate the clinical context. Members of the CDISC
We are members of Clinical Data Interchange Standards Consortium (CDISC) and our database programmers stay abreast of industry guidelines.
BRILLIANT Consortium Partner
Provided data management for Phase 1 first-in-Africa HIV vaccine trial. Recognised as top place to work in South Africa
Ranked in the Sunday Times Top 15 Best Places to Work in South Africa (2024). Trusted Relationships
Built trusted relationships with industry leaders, sponsors, drug discoverers and academics. Clean Audits
Zero critical findings in vendor audits. Capacity Development Programme
We hire new university graduates as interns, train them to fulfill permanent functions in the company, equip them with important skills and in doing so, building the capacity of young South Africans in clinical data management.The BRILLIANT Consortium (BRinging Innovation to cLinical and Laboratory research to end HIV In Africa through New vaccine Technology), led predominantly by African women scientists, comprises a multi-disciplinary collaboration from Nigeria, Uganda, Kenya, Tanzania, Zimbabwe, Zambia, Mozambique, and South Africa. The consortium represents the current brain’s trust and future capacity of HIV vaccine research and development in sub-Saharan Africa, with the overall objective of developing and evaluating HIV vaccine candidates emanating from our continent. Our Values
Our Values
Our Values
Innovation
We embrace the future of clinical data management by seamlessly integrating AI, genomics and other ground-breaking approaches to revolutionise the field.
Passion
We are driven by a relentless passion for advancing clinical research through impeccable data management.
Integrity
Trust is the foundation of our work, ensuring ethical practices and utmost data integrity every step of the way.
Excellence
Delivering unparalleled excellence, we empower you to make informed decisions based on the highest quality clinical data.
Learning and Development
We foster a culture of continuous learning and development, empowering our employees to unlock their full potential and drive skills growth within BioInformatiCo and the South African workforce.
Our
Services
Our Services
Our Services
We offer a range of data management and other related services tailored to meet the diverse needs of our clients - Comprehensive Clinical Data Management Solutions
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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.
- Value-Added Reporting for Study Optimisation
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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.
- Validated Customised Integrations
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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.
- Dedicated Safety Reporting Desk
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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.
- Drug Safety and Pharmacovigilance Services
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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.
- Biostatistical Expertise
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Our 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.
Biostatistical Expertise - REAL-WORLD DATA INSIGHTS
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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.
- Medical Writing and Report Publishing
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We have medical doctors and Clinical Study Report (CSR) specialists who can author appropriate documents, including CSRs.
Medical Writing and Report Publishing - Clinical Trial Project Management
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BioInformatiCo 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.Clinical Trial Project Management - Medical Monitoring
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Our 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.Medical Monitoring
Learn More
Comprehensive Clinical Data Management Solutions
We 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.
Value-Added Reporting for Study Optimisation
We 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.
Validated Customised Integrations
Our 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.
Dedicated Safety Reporting Desk
Our dedicated clinical team stands ready to address any safety concerns or symptoms encountered by trial participants, providing swift and effective support whenever needed.
Drug Safety and Pharmacovigilance Services
We 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.
Biostatistical Expertise
Our 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.
Real-World Data Insights
Leveraging 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.
Medical Writing and Report Publishing
We have medical doctors and Clinical Study Report (CSR) specialists who can author appropriate documents, including CSRs.
Clinical Trial Project Management
BioInformatiCo 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.