BioInformatiCo is a clinical data management contract research organisation (CRO) that offers a range of clinical data management solutions tailored to the needs of each clinical trial and sponsor. Our services include comprehensive clinical data management, value-added reporting for study optimisation, validated customised integrations, dedicated safety reporting desk, drug safety and pharmacovigilance services, biostatistical expertise, real-world data insights, and medical writing.
We have a diverse and multidisciplinary team consisting of medical doctors, engineers and skilled professionals with the experience and capability to execute and deliver the required services.
BioInformatiCo oversees all data management activities involved in clinical trials, including drafting data management plans, electronic case report form (eCRF) design, programming data validation requirements, database setup, site training, query management and resolution, safety and medication coding, operational study reporting, laboratory data management system meta-data reconciliation, data transfers, supporting electronic trial master file (eTMF) documentation and medical writing services.
Our biostatisticians assist with study design and planning; preparing the statistical analysis plan (SAP); developing the randomisation schedule or assigning the randomisation parameters; designing, producing and validating tables, listings and figures (TLF) shell specifications for interim analysis, data safety and monitoring board (DSMB) and institutional review board (IRB) meetings, as well as for the clinical study report (CSR).
Industry standards and validated computer systems
All relevant BioInformatiCo staff are equipped with knowledge and training on ALCOA++ principles, 21 CFR Part 11, good clinical practice (GCP), GAMP 5 categories 4 and 5, and the NIAID Division of AIDS (DAIDS) policies and procedures. We are members of the Clinical Data Interchange Standards Consortium (CDISC) and our team stays current with evolving industry standards.
BioInformatiCo uses computerised systems to improve the efficiency of clinical trial research and operations. Our validation strategy ensures third-party software validation, configuration of validated software prior to study/protocol go-live, validation of BioInformatiCo-developed software, and software configuration validation.
From our inception, we have demonstrated agility in meeting sponsor needs without compromising our commitment to excellence. Because no two clinical trials are the same, we evaluate the needs of each clinical trial and sponsor and select a system that can deliver on those study and regulatory requirements.
Producing high-quality data for clinical trials
At BioInformatiCo, we understand that data can offer valuable operational and strategic insights to the study team, aiding in protocol adherence and overall study project management. Our clinician-led data management team develops automated reports and listings to make data readily accessible for the study team and proactively analyses these reports to allow the study team to collaboratively address any concerns promptly.
All procedures are governed by our quality management system to ensure the creation of high-quality datasets, and we adhere to Clinical Data Acquisition Standards Harmonisation (CDASH) in the setup of the clinical data management system. We ensure that the clinical data management system contains a range of data quality rules programmed to reconcile data entered at participant level and monitor protocol adherence. Periodic quality assurance data review procedures are performed during the study. We develop a set of comprehensive reports (smart listings) that summarise key data metrics to facilitate data cleaning, activity monitoring and the identification of data anomalies.
Our biostatisticians play a critical role in ensuring the quality of data collected in clinical trials. They contribute to protocol design, data management, statistical analysis and reporting, ensuring that the data is collected accurately, analysed appropriately and presented effectively. By actively participating in all stages of the clinical trial process, our biostatisticians ensure our sponsors receive high-quality data that can be used to make informed decisions about the investigational product’s safety and efficacy.
Your premium data management partner in Africa
BioInformatiCo was established amid the challenging backdrop of the Covid-19 pandemic in response to the need to develop local capacity in clinical data management in Africa. We have already done so in 47 clinical research sites across seven African countries. Our footprint extends throughout sub-Saharan Africa and we are committed to developing our capacity in South Africa and beyond.
We recognise the importance of diversity in clinical trials and research. For those aiming to recruit diverse populations, our geographical location and experience in sub-Saharan Africa make us an ideal partner. We pride ourselves on data managers who understand research site operations and the associated clinical context.
Current sponsors supported by our data management team
BioInformatiCo supports the NIH-funded HIV Vaccine Trials Network (HVTN) and Covid Vaccines and Prevention Network (CoVPN) as the appointed clinical data management service provider for the Ubuntu CoVPN3008 clinical trial. We completed the mid-study data transfer of this large Phase III safety and efficacy study, which was conducted in 47 sites across Africa with more than 14,000 participants.
Since then, we have overseen all of the study’s clinical data management activities. We also support the HVTN with clinical data management for the Ubuntu CoVPN3008 TB Sub-study, initiating the go-live of this Phase IV TB study with 6,000 participants.
In addition, BioInformatiCo is the appointed clinical data management partner for the USAID-funded BRILLIANT Consortium (BRinging Innovation to cLinical and Laboratory research to end HIV In Africa through New vaccine Technology), a $48m cooperative agreement led by Professor Glenda Gray from the South African Medical Research Council (SAMRC).
We are passionate about providing our sponsors with high-quality data so that we can expedite medical discovery. Get in touch with us to discuss your next project.
