Bringing Clinical Trials to the People using EDC
Electronic Data Capture (EDC) is a system of capturing and managing clinical trial data on a digital platform to replace traditional paper-based data capture. Using such a system not only lets you capture data securely but also expedites the research process, ensures data reusability and is one of the biggest ways that more diversity can be brought into the process of completing clinical trails. Most EDC systems nowadays are cloud-based, ensuring secure access from anywhere.
What kind of data is collected in EDC systems?
EDC systems collect different types of data depending on the therapeutic area of the clinical trial.
For instance, in oncology studies, the following data forms are typically used: demographics, medical history, vital signs, ECOG performance status, electrocardiogram data, biochemistry, hematology, coagulation tests, urinalysis, pregnancy tests, adverse events, concomitant medications, tumor assessments, treatment data, survival follow-up, and death information, among others.
OnTracka has patients using the platform in anonymised form, this means no personal details that can identify the individual are grouped together to better understand the impact of the medicine. This is where the value comes from. The patients have to give their explicit consent for the data about their medicines to be collated, and OnTracka make sure this is very clear to them.
Ontracka Research - What is means for you?
Customised patient-centered research and development tool designed to collect and submit credible data for drug development and regulatory decision-making.
Decentralized research tool delivering Patient-reported outcomes (PRO), Observer-reported outcomes (ObsRO) measures and Performance outcomes (PerfO) measures.
Time-stamped recording of prescribed medications along with proprietary features to accurately measure onset/titration times and the optimal dosing for each patient’s individual needs.
Innovative plug-in solution that provides a collaborative and efficient way to manage the data monitoring and site query process for data managers, site monitors and medical reviewers.
All the studies are protected by industry best practice security, industry regulations and data privacy technologies that include but are not limited to ISO 27001 Compliant, CDISC Compliant, GDPRA Compliant & FISMA Compliant.
OnTracka has several on-going studies and will soon be recruiting for a project which is looking at treating chemo-induced nausea and vomiting for cancer patients.
OnTracka is also working on a clinical trial in Spain, which is examining the use of Ayahuasca for the treatment of depression. The OnTracka app is helping collect long-term follow-up reports on the impact of the treatment on the 150 patients involved in this trial. Contact us if you want to enroll yourself in clinical trials through OnTracka app. Available for both iOS and Android, download the app now