With the rise of electronic data capture (EDC) has come a raft of regulations on data use such as the EU’s GDPR. Clinicians reliant on digital management systems need to ensure they are respecting the relevant laws on data privacy and patient confidentiality wherever they run their trials.
Failure to manage these regulatory complexities can result in spiralling development costs, lengthy delays, and siloed data. All of these can have an enormous impact on trial budgets and schedules. To avoid any complications, clinical trials need to use EDC systems that offer flexibility and transparency in data management.
Why is correct data management important?
Following correct data practice is especially important because any issues with data integrity can undermine a trial’s credibility. Alongside large fines, clinicians who fail to respect the right data regulations could also see their drug submissions rejected by the approval authorities. Losses in the billions of dollars could result from pausing or restarting the trial.
“At the moment, clinical trials already need to do more with less. So, they have to avoid any unnecessary financial strain,” notes Alan Yeomans, regulatory affairs manager at Viedoc.
“Pharmaceuticals are measured by time to market. The sooner you can get your medicine to the marketplace, the more patients you can help. But if your trial has to restart, that’s two or three years down the drain,” he adds. “When it does go to market, the overall profit you make from your medication will be less because you need to recoup all the development costs.”
To help manage the rising volumes of trial data and simplify regulations for trials operating across multiple countries, recent years have seen an increase in guidance on handling computerised systems in clinical studies.
“Pharmaceuticals is an international market, and every country is responsible for their own regulations and laws. But there is a large degree of harmonisation,” says Yeomans. “Frameworks such as Good Clinical Practice (GCP) make life a lot easier so that everyone is cooperating.”
Managing clinical regulations across different regions
Clinical regulations often differ between territories, and these must be complied with. Clinicians using EDC and digital platforms to manage their trials must use adaptable software that meets the varying legal requirements.
Viedoc provides intuitive software that streamlines, automates, and simplifies conventional processes within clinical research. The company’s platform makes every aspect of a clinical study more user-friendly and familiar, while ensuring the technology is reliable, scalable, and cost-effective. With so much at stake for clinical trials that fail to meet data regulations, Viedoc is committed to providing flexible digital infrastructure.
“We want our system to be compliant irrespective of where our customer is and where they’re running their trials,” explains Yeomans. “If they’re running one trial in the US and one in Japan and one in Europe, we want them all to be compliant with the regulations.
“We can’t produce a system that you can only use in the EU. We’re a global company. Everything comes down to patient safety and data integrity.”
Furthermore, it is imperative that regulators are not viewed as an obstacle, but more as a collaborative partner. “One of our strengths is the collaboration we directly have with the regulators,” says Marialuisa Baldi, quality assurance officer at Viedoc. “The customer needs to know how to use the systems in the best way and how to set the right procedures to do that,” she adds.
Improving data transparency
Another issue that has emerged with the digitisation of clinical trials is siloed data. Some trials can use up to ten different computerised systems in a single study, which poses problems when sponsors need to submit one single data set to the authorities for regulatory approval. No data should get left behind at this critical juncture.
Viedoc’s platform can integrate all data sources, including those from wearable health tech, into one comprehensive system. Additionally, the platform has reacted to increasing demands for audit trail reviews to improve data transparency.
“We’ve added tools to help users identify when things are going wrong with their data,” explains Yeomans. “The process is automated quite simply. You don’t need to sit down as a data manager and go through everything in the data. You push a button to generate a report that you can look through quickly to see if anything needs your attention.”
Data integrity remains integral to new drugs securing regulatory approval. Clinicians seeking to remain on schedule and on budget must invest in the right tools that can adapt in line with varying legislation around the world.
“Clinical trials are changing in terms of workflow, and also in terms of technology to reach as many subjects as possible,” adds Baldi. “There is a true interest in technologies and how we should use them in the best way to ensure patient security, which is the main goal here.”
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