Risk Identification

Every site is different from the other and hence the risks associated with them are also varied. The risk management strategies identified for one might not be applicable for the other. In this case technology can be of major help in identifying the possible risks associated with each of the sites through an estimated evaluation of their past records. This would enable the Clinical Research Associates (CRA) to put forward a unique risk management strategy for each site.

Action Alerts

Identification of abnormalities with every site visit might be quite time consuming. This slow process might even create a hindrance in the process of taking actions. The AI driven technologies are always active, thereby alerting the drug manufacturers as and when the defined metrics are crossed.

Risk Mitigation

When risk identification is solely being carried out by technology driven tools, the research associates can shift their complete concentration to the alleviation of the previously identified risks. The mitigation of risks in a timely manner will help in the completion of the clinical trial process faster.

Data Verification at Source

There are multiple sources that the data is drawn from; verifying the data after a considerable amount of time increases the workload. With the verification of the data at source through the utilization of technology would not only save time but even make the procedure smooth.

The utilization of technology might be new in the field of clinical trial monitoring but the benefits that they bring forth are immense. The use of such AI driven GRC tool like TULA will enable the organizations to save their hard earned time and work towards the reduction of the soaring costs. The complexity is increasing in the medical world and its only technology that can prevent it from taking a toll on the entire industry.

of risks are addressed by teams in clinical projects.

30%

of the risks or either siloed or trapped in functions.

50%

A vast majority (50%) are unreported and lost.

If you know your risks, I’m sure you or your teams manage them well (with KRIs or thresholds or logs or trackers). Question is what are you doing about the remaining 80% of risks. Most companies leave this key part to either untrained teams or vendors (and some of vendors doesn’t know risk management except to update a risk log before audits). Some of these are contributing factors for TUFTS projecting the increasing costs for drug development year-on-year.

Without addressing this effectively, no matter how well you optimize your processes or outsource or offshore or other methods you adapt, you may not get full efficiencies ion Time gains or Cost savings.

TULA (Governance, Project/Program Performance, Vendor Oversight, Risk and Compliance solution) ensures this. Instead of focusing on just analytics or just telling the teams “what” happened, it focuses on “Why that happened” and more importantly “What to expect in near future” so that the teams can focus ONLY on the parts that they NEED to act on and not the drudge of several charts/graphs and overload of just fancy reports.

Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple apps, managing data & content across systems, limited collaboration, ease of use, Compliance with standards and the list goes on. To overcome these challenges, you need a single source of truth for your entire Clinical process, underpinning every decision made. TULA helps clinical teams to manage complex processes, identify risks, capture data from applications across the business, automate workflows, and create instant KPI dashboards.

From a quality perspective, TULA provides visibility into performance across study/project portfolio will enable companies to have a single source of truth to utilize for systematic monitoring of portfolio, project and studies performance, risk and compliance policies across. With growing reliance on CROs for development projects having a standardized tool that ensures metrics measurement confidence is paramount to the overall success.

Some example features you may want from TULA solution:

• Get real-time insights into performance across your business. You can track sites / Projects / Programs and share what is working well.
• Systematically keep on track of document and policy life cycles – get the software to do this for you! No more searching through thousands of duplicated documents.
• Drive actions (with timely Alerts & Predictions)
• Bring all your data together, instantly. No more chasing departments for data.
• Give employees the opportunity to speak up about risks they see and identify issues before they occur.
• No siloed systems (RBM, ICH E6 R2 compliance, Central Monitoring & others are all built-in)
• Improves overall efficiency and productivity of organization

TULA makes teams truly Proactive (most teams in most companies are either Reactive or keep them in auto pilot). TULA applies this to all projects, programs, vendors, CROs, and sites all at a time in one platform and liberates this crucial info form trapped siloed teams/functions/systems. No tool in market has TULA’s pre-built ready-to-go functionality. This helps companies use this complex functionality with less than 3 months implementation, all delivered in cloud