Struggling with costly ICH-E6-compliant oversight? Near-real-time portfolio oversight has arrived.

When International Council for Harmonization (ICH) E6 (R2) guidelines came onto the scene, the big takeaway sparking chatter at the watercooler of pharma companies everywhere was the implications for greater adoption of risk-based monitoring. But section 5 of the guidance introduced a pivotal shift in the responsibilities of sponsors that is just as impactful, particularly to small and mid-size pharma. In short, the section mandates that sponsors accept full responsibility for the oversight of their clinical trials, even if (as is the case with many modern trials) conduct responsibilities are outsourced to contract research organizations (CROs) and other vendors. In a nutshell: as the clinical trial sponsor, the buck now stops with you.

If you are a small or mid-size pharma company, implementing a Clinical Trial Management System (CTMS) to take on this responsibility requires overhead and workflow and transactional complexity you don’t necessarily need. But without a simple solution to continuously consolidate multi-source CRO data into standardized views and analytics, you are left in a bind. You need current data from vendors for actionable oversight, but often only get those insights via the vendors’ monthly reporting. The varying data cadence of multiple vendors means you are typically working with some data that is relatively new and others a month old or more —hardly a comprehensive picture of a trial to reassure executives’ oversight concerns. To add insult to injury, the reporting from multiple vendors is — you guessed it — also in multiple formats, making the job of uniting the data streams to glean any meaningful insights a messy and time-consuming process.

All current data for all studies, harmonized in a single hub

In this day and age, comprehensive, current portfolio oversight shouldn’t be this much of a headache, and it definitely shouldn’t require IT involvement that drains your budget. IQVIA’s Clinical Data Analytics Suite (CDAS) can solve this challenge and give customers easy-to-use dashboards and a real-time view of critical KPIs regardless of who is conducting individual trials. CDAS is self-service and vendor-agnostic, meaning even with multiple vendors and formats, setting up this solution to bring your portfolio data into a current, harmonized, and easy-to-report format is quite simple and cost-effective.

Part of what makes me so excited about this solution is the impressive value will bring. We anticipate a 75% time-savings for organizations by minimizing things like data aggregation and standardization tasks and metrics calculations for their portfolio. Perhaps more importantly, they will get all relevant oversight data (including clinical, operational, monitoring, site status, and recruitment) in mere hours versus weeks.

CDAS makes acquiring and standardizing data achievable without the complexities of point-to-point integrations. It starts by connecting and controlling the flow of information from all of your clinical trials, whether it is structured, unstructured, or semi-structured, in near-real time. What’s great about CDAS that it can rapidly ingest data from literally any source — regardless of vendor — with a self-service experience and intuitive setup. Data that sponsors used to wait a month for is now accessible in just minutes, allowing them to action challenges when they happen — not weeks after the fact. With flexible connectors, establishing CDAS in your organization is significantly faster than a full IT integration (not to mention much less costly). Next, CDAS allows you to shift all that ingested data from third-party sources to a standard, harmonized data model. That means your enterprise will have self-service access to all these data streams, allowing for synergies across departments that were previously challenging to achieve.

Once you are positioned with all your current portfolio data harmonized in a single, centralized location, you can start putting your data to work — and this is when the real magic happens. You can use CDAS’s clinical data analytics capabilities to analyze, track, compare, and oversee all your clinical trials at any time, on demand. Your trial reports no longer look different for each study coming from a different vendor. CDAS comes equipped with out-of-the-box standard dashboards to align everything from portfolio status to study and site activities, enrollment metrics, protocol deviations, and more. This solution is completely flexible to the needs of your organization, so you can create your own custom dashboards as you see fit. It is also embedded with IQVIA’s unparalleled domain expertise to enable predictive analytics that can shift your oversight from reactive to proactive. Oversight tasks that were once an administrative headache are gone. Now, your focus is on intelligent strategy and proactive risk mitigation to run better trials.

Looking ahead

While everything we’ve discussed here is exciting on its own, the future looks even brighter. That’s because we are already exploring the use of a secure, ChatGPT-like large language model (LLM) to pair with CDAS Clinical Analytics.

How would that look? Imagine dashboards on demand, produced by a co-pilot you simply prompt to automatically generate a visual dashboard for anything from site performance to milestone data to enrollment figures, and more. Such an AI-driven co-pilot could intake a question like, “help me understand trends in protocol amendments for my trials,” and not only produce the relevant dashboards, but also use IQVIA’s embedded intelligence built into the solution to assess them and suggest next best action or proactively flag risks.

We’re not far off from this reality, and if we’ve learned anything from the recent explosion in AI and technology, it is this: early adoption will be key to keep pace. Are you interested in getting ahead of the curve to start reaping the benefits we discussed here in your own organization? We are actively recruiting for pilot projects. Reach out to IQVIA Technologies today to start the conversation.