For quite some time CROs have delivered services to sponsors by hosting their clinical trial data, making it unnecessary for a sponsor to build their own clinical database. Such an arrangement relieves a sponsor from the cost as well as regulatory risk of establishing their own new clinical database. But, it can also markedly compromise the sponsors’ ability to respond to evolving events (e.g. safety signals) which stretch timelines and affect compliance requirements. CROs are increasingly making it easier for sponsors to access and analyze their data while the CRO continues to host the database.

The challenge for the sponsor’s clinical data management is that the company rarely works with one CRO, and often relies on one EDC system as one size doesn’t fit all. Whereby in the quest for streamlined operations, efficiency and faster decision-making, the sponsors’ clinical review and data management users may end up doing multiple hops to desired data with a huge lag and have to rely on multiple systems to access the required data.

Data Integration is the only recourse to connect the numerous data silos that are created in the process. Clinical research is a complex world; while the data management process remains hybrid, depending on the type of study, the size of the organization, and the distributed nature & type of the data capture, the complexity of data integration increases. The result is a very long cycle from Data Capture to Analysis and eSubmission.

• How can a life sciences organization with a primary focus on research and a goal of accelerating drug development to market maintain focus on core areas without getting distracted by the overhead of managing multiple CROs and multiple clinical software systems?
• How does a sponsor organization maintain, control, perform faster reviews and gain real-time transparency of the process in an outsourced clinical data during trial and post-lock?
• How does a sponsor organization gain operational efficiency and cost control by leveraging standardized clinical trial metadata across their clinical trial portfolio and further retain control of study design & setup by using reusable configurations?

About MaxisIT:

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.