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What would you expect from a platform which offers to manage your clinical trials? Would you expect timely access to as authoritative, standardized and aggregated clinical trial operations data as well as patient data from site, study to portfolio level? Would you need efficient trial oversight via remote monitoring, statistically assessed controls, data quality management, clinical reviews, and statistical computing? Would you expect it to learn the patterns in the data and identify any discrepancies soon as they occur, in real-time?
If you don’t, it’s time you did. Yes, you heard that right. Demand more. Never settle.
Ensuring the Timely access to authoritative Data
After all, clinical trials are known to face issues with time and cost overruns. They could also fail to enroll on time, quality compliance, or low performance. Many even fail to clear the hurdles set by regulatory requirements. All this happens because the data was not accessible timely and required insight was not delivered to enable in-time decision making and issues were not identified or flagged in real-time and addressed appropriately.
Authoritative data is the sine-qua-non for any successful clinical trial. Only then would a trial stay within budget, meet its timelines and adhere to compliance requirements. There’s no disputing the fact that clinical data managers work very hard to ensure that their data is clean, but their task becomes superhuman as the data gets generated at tremendous rates and keeps on piling up. There’s always a risk of finding some gaps as some data usually goes missing. All these aspects make the task of a clinical data manager almost impossible to be done manually without the help of a tool.
How can technology help?
The market may be full of tools, but it’s important to ask if a tool has the required capabilities. It could help to improve the time taken to complete the task, beyond all recognition. It could aggregate all the clinical data in real time, across the data silos created by the disparate EDCs, CTMSs in use by the CROs and partners. It could offer a process powered by artificial intelligence and machine learning. It could go up the learning curve to quickly identify the trends in the data to flag any outliers and mitigate possible risks and manage the KPIs. It could offer actionable insights which support proactive action.
With the right technology, the data speaks to the mangers in various ways, like the following:
Who wouldn’t want to have a single tool which offers you all these capabilities, across your entire clinical trials portfolio?
Wake up call to Data Managers
Data managers need to refuse to be martyrs to their profession and be stuck with managing everything without the help of the right tool. Diversified host of eClinical systems only add to the issue, by creating siloed data and cannot offer an integrated view of all the trial data in real time. Technologically advanced tools like MaxisIT’s CTOS have been here for the last 17 years – with industry leading capabilities which make it possible for data managers to gain total oversight over their clinical trial portfolio data and enable them to take proactive action in real time. Data managers literally get into the driving seat when they adopt MaxisIT’s CTOS.
At MaxisIT, we clearly understand strategic priorities within clinical R&D, as they resonate well with our own experience of implementing solutions for improving Clinical Development Portfolio via an integrated platform. An ideal platform delivers timely access to study-specific as well as standardized and aggregated clinical trial operations as well as patient data, and allows efficient trial oversight via remote monitoring, statistically assessed controls, data quality management, clinical reviews, and statistical computing. Moreover, it provides capabilities for planned vs. actual trending, optimization, as well as for fraud detection and risk-based monitoring.
MaxisIT’s Clinical Trials Oversight System (CTOS) enables “data-driven digital transformation” by its complete AI enabled analytics platform. From data ingestion, processing, analysis to in-time clinical intelligence by establishing value of data. The CTOS empowers clinical stakeholders to mitigate risks and seize the opportunity in the most efficient manner at a reduced cost.
7 Nov 2019