Clindata International, a South Africa-based CRO specializing in Animal Health clinical trials, has used Medrio EDC since 2013. By joining the Medrio Partner program, which offers business and training benefits to qualifying CRO customers, Clindata was able to offer electronic data capture (EDC) to sponsors who had not originally budgeted for EDC, as an added benefit. Medrio EDC has allowed Clindata to build an extensive animal health form library that sponsors can utilize when moved onto this model. Through a partnership with Medrio, Clindata was able to move 21 animal health studies from paper to EDC, resulting in cleaner data and faster database lock.
Clindata subscribes to a concurrent license model of Medrio EDC allowing 20 independent trials to run concurrently through Clindata. Since implementing this model, Clindata has successfully eliminated paper processes from 21 Animal Health studies. Given this initial success, the Clindata team hopes to move as many paper studies as possible to EDC.
Clindata recommends EDC to all of their sponsors. As part of their Medrio partnership, Clindata is able to offer EDC to sponsors who have not calculated an EDC system into their budget. This added benefit gives Clindata an advantage when sponsors are choosing a CRO partner.
I do not sleep at night with multiple studies running on paper because you cannot monitor the quality of paper studies in real-time. I rest easy knowing that the data collected via Medrio EDC will be clean, accurate, and complete.”
– Jaco Kasselman, Director of Animal Health Research, Clindata
“To start a study on paper is easy, the ramp-up time is low and studies can start almost immediately. Things get complicated, strenuous, and labor-intensive when moving from start-up to conduct with an animal health trial on paper. Paper studies require manual tracking, double data entry, data comparisons, quality checks, and more, and even still data will inevitably go missing. All of that can be eliminated with Medrio’s electronic data capture (EDC),” explained Jaco Kasselman, Director of Animal Health at Clindata.
While it does take time to build and validate the EDC database, it provides for more efficient conduct and closure of animal health clinical trials. Time spent on manual review of paper is eliminated. Clindata and their sponsors can now monitor trials in real-time and rest assured that data is accurate and complete. No more missing entries, manual query, or edit checks; it’s all done automatically in real-time once the EDC is validated and data entry begins.
Since 2013, Clindata has used Medrio EDC as a highly effective solution to the specific challenges and data management needs of the Animal Health sector. Joining the Partner Alliance Program has increased Clindata’s use of Medrio’s EDC, thus resulting in additional efficiencies and a more robust Animal Health form library. “Animal Health studies are heavily scrutinized by regulators, which is why ensuring data integrity through ALCOA is paramount to success. Medrio offers an audit trail that reduces manual edit checks and source data verification. When coupled with the form library that we’ve built, we’re able to close out studies with peace of mind that our data is accurate and complete for regulators,” said Kasselman.
Medrio’s multiple-subject data entry tool has also been a major source of efficiency for their Animal Health studies. “Multiple-subject data entry has been a major deciding factor in us using, and staying, with Medrio,” says Kasselman, “We haven’t seen other software tools that enable us to enter data like in a lab environment, just going from subject to subject and capturing the data we need. That makes life a lot easier for our team.”
Kasselman also expanded on how the ability to copy databases from previous studies and the simplicity of removing forms and making revisions as needed has empowered Clindata to cut their build timelines in half when starting new studies. As a result, the data management team has been able to get their databases from the final protocol to the first data entry in just five days. “Everything is as the sponsor needs. Getting everything standardized and validated up front really helps us reduce study setup times,” detailed Kasselman.
With 19 studies in progress, Clindata is looking forward to moving more studies away from paper and to electronic data collection. “I think the sector is seeing the benefit of EDC, when data is more accurate and complete, everybody wins,” said Kasselman.
“Multiple-subject data entry has been a major deciding factor in us using Medrio and staying with Medrio…,” says Kasselman, “We haven’t seen other software tools that enable us to enter data like in a lab environment, just going from subject to subject and capturing the data we need.”
– Jaco Kasselman, Director of Animal Health, Clindata
Founded in 2012, Clindata is a Contract Research Organization (CRO) based in South Africa. The Clindata core team of experienced, dedicated staff has worked for CRO’s in the animal health industry for many years. We bring a wealth of Data Management, Biostatistics, and SAS experience and pride ourselves in our streamlined and compliant set of SOP’s. Our mission is to support the implementation of One Health by recognizing that the health of our animals is connected to the health of humans and the environment.
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