More manpower = less development time? Not necessarily.

By Suvarnala Mathangi | Date: February 29, 2020 | Blog | 0 Comment(s)

Hiring more manpower is not the answer to getting your clinical trials’ timelines back on track. If anything can help, that would be the adoption of technology and more specifically, AI. The new way to cut the timelines of clinical trials short is to leverage artificial intelligence to drive the processes.

Manage Data to Manage your Trial

Let’s look at how AI can be of help to manage clinical trials which need to adhere to regulatory compliance requirements as well as regulator-approved data standards & reporting. Not to forget the challenges with patient recruitment, data sources and data collection and aggregation. During a clinical trial, a large amount of data gets collected across the variety of eClinical systems, wearable and external sources, requiring the ability to manage, ingest and standardize it without delays.

Clinical trials stay compliant only when the system can check all the input data, verify its source, standardize it and ensure its quality and accuracy as per protocol parameters. AI not only helps to standardize the data but also learns to detect any deviations as it processes the data from the various sources to create a single source of truth which is compliant with regulatory standards.

Most clinical studies also face challenges with time and cost overruns, while study quality itself refuses to be maintained at an optimum level. All these challenges can be resolved and the success of a study can be ensured when we have access to and oversight of ready and relevant information. Apart from ensuring the success of the study, such a capability would make it possible for trial managers to not be overwhelmed by copious amounts of data and to quickly respond to any crucial red flags and prevent costly delays by resolving their root causes.

Development Time manages itself

When data gets captured and integrated with all the other data in the data repository, clinical data management processes turn seamless and on time. Quick access to reliable data helps all the study stakeholders to focus on clinical tasks of higher value and regularly monitor their KPIs to coordinate all stages of the trial. AI helps here too by matching the real time data to historic data as a benchmark and flag any issues in real-time, making immediate corrective action possible. As AI helps the study to stay on track and meet its milestones, it can also help with the site and patient outcomes by finding the most relevant populations.

With AI, we can also enjoy end-to-end automation and faster clinical trials along with its automated analytics which offer actionable insights which power further improvements in the clinical trails’ processes. All these would help to keep the development on schedule and the clinical trial on track.

About MaxisIT

At MaxisIT, we clearly understand strategic priorities within clinical R&D, and we can resonate that well with our similar experiences of implementing solutions for improving Clinical Development Portfolio via an integrated platform-based approach; which delivers timely access to study specific as well as standardized and aggregated clinical trial operations as well as patient data, 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 Integrated Technology Platform is a purpose-built solution, which helps Pharmaceutical & Life sciences industry by “Empowering Business Stakeholders with Integrated Computing, and Self-service Dashboards in the strategically externalized enterprise environment with major focus on the core clinical operations data as well as clinical information assets; which allows improved control over externalized, CROs and partners driven, clinical ecosystem; and enable in-time decision support, continuous monitoring over regulatory compliance, and greater operational efficiency at a measurable rate”.

Let the Data do the Talking

By Suvarnala Mathangi | Date: February 29, 2020 | Blog | 0 Comment(s)

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:

1. No need for manual reconciliations, and their entire clinical data portfolio gets integrated to present a data repository, which acts as a single-source-of-truth.
2. The data from disparate EDCs and siloed CTMSs gets aggregated and integrated, in real-time, across the various CROs who are managing the trials.
3. Risk is mitigated as issues are flagged in real-time and brought to the attention of the clinical data managers, for immediate corrective action, if not resolution.
4. Role-based dashboards offer actionable insights for proactive action, in real-time.

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.

About MaxisIT

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.