The demand for wearables and sensors in clinical trials is on the rise. Pharma companies are increasingly challenged with both rising costs and the need to find novel ways to differentiate the drugs they are developing. One such way is by accessing the clinical data collected using remote medical devices.
By leveraging remote medical devices, there is an opportunity to collect novel endpoints and supplemental data that may improve the regulatory case, make the case for reimbursement more compelling, open up participation to a wider population and/or reduce site visits for patients who may not live close to an investigative site.
However, large volumes of continuous flowing data will increasingly require scalable cloud support along-with a proactive approach to data standardization. Data standardization assumes vital importance because there are large chunks of unstructured data that can overwhelm traditional functions and processes.
A good data standardization platform will enable better clinical data quality management, clinical data review and reduce cycle time by creating submission standard deliverables. An ideal platform should enable –
- Self-learning mapping, metadata driven automation with built-in security and regulatory compliance
- Ability to scale up and scale-out on demand for faster time value realization
- An integrated self-service approach to automated data standardization.
MaxisIT has shown tremendous success in delivering value based on standardizing over 800 clinical studies. Be it the self-service platform or functional outsourcing, MaxisIT has delivered consistent quality, compliance and cost reduction. If you want to know more, please do ask for a demo.
At MaxisIT, we believe that complex data analysis can produce simple yet powerful insights.
MaxisIT’s Clinical Trial Oversight System (CTOS) is a purpose-built command center designed to manage biopharma and life sciences clinical trials as mission-critical business processes. With its complete AI-enabled analytics platform, the CTOS enables “data-driven digital transformation” from data ingestion, processing, and analysis to in-time clinical intelligence. Its real-time data ingestion, analytics, and visualization empower researchers to identify and address errors as they occur.
The CTOS elevates the value of data, improves efficiency, and empowers clinical stakeholders to seize new opportunities. The platform brings clinical operations and patient data together in a single, central data hub as a single-source-of-truth to help clinical operations, clinical data management, biostatistics, and clinical R&D portfolio management.
A complete self-service, AI-enabled analytics platform, the CTOS unifies trial data from disparate eClinical systems to support study planning, clinical data quality, clinical review, patient safety, clinical operations, CRO performance, risk-assessment, portfolio management, compliance, and submission.
From study setup to data ingestion, clinical trial stakeholders can manage clinical development processes with insight into the study conduct and take proactive actions to reduce costs, mitigate risks, and ensure compliance.
MaxisIT’s CTOS helps you maintain an ongoing health-check on your portfolio of clinical trials, using real-time data, analytics, and visualization to drive rigorous analysis of the entire dataset, allowing for proactive trial risk management.