Accelerate data ingestion to submission with Pinnacle 21

It can be a challenge just getting external vendor data supplied in a reasonable timeframe! And even when you have it, typically a lot of work is needed to ensure data integrity and regulatory compliance. The data must be validated, reconciled and transformed into the correct structure and format for analysis. Since non-CRF data accounts for over 70% of trial data – coming from multiple sources – this quantity and complexity puts you at real risk of end-of-study delays and quality issues.

The Pinnacle 21 (P21) platform has everything you need to ease the process of external vendor data reconciliation! Spec management, data delivery, validation, and issue management tools are combined to reduce data delivery timelines, streamline resources, and speed time to analysis.

One top pharma client averaged 50-75% time savings on data transfer spec review!

Easily create data transfer specs

The P21 platform lets you collaboratively create, manage and validate specifications in real-time. Relevant teams can easily review and edit specs in one central location – rather than wading through multiple spreadsheets and email chains!

Standardize & reuse specs

Establish a central library of reusable standards for non-CRF data collection. The hard work is done once, then specs can be standardized and reused in subsequent studies. As a result, significant time savings can be made on the vendor specification process.

Ensure quality & compliance

As vendor data is sent by secure file transfer, deliverables are validated against your specs, including checks against structure, code lists, and values. This in-stream validation provides an actionable list of issues for vendors to review in real-time. As a result, high quality, clean, compliant deliverables are secured from the outset.

Quickly resolve issues

Having a central platform for internal and external teams to manage data collaboratively, dramatically reduces timelines. Vendors can easily see and address non-EDC data issues, and all teams can collaborate transparently to resolve issues much faster.

Collaborate in one place

There’s one central location to review, edit, and reuse specs, manage issues, aswell as receive and validate vendor data. Multiple files types, including CSV, SAS datasets, and Excel files can be delivered, and access to relevant stakeholders can be managed centrally too.

Built-in dashboards

P21 provides a valuable source of metrics and analytics to aid decision making. Dashboards provide detailed metrics across therapeutic areas, projects, studies, and vendors. Track turnaround times for spec development, data delivery, and issue resolution. Even monitor transfer file quality and automate workflows.

Reduce timelines and get greater quality from vendors

Avoid weeks or even months waiting on vendor data. In-steam validation ensures higher quality deliverables from the outset. And external vendor data reconciliation tools massively reduce issue resolution timelines. A top ten pharmaceutical company reports saving on average 400 operational hours per study annually with our platform!

Improve efficiency with streamlined processes

With one central platform for collaboration and communication, there’s fewer systems to use and support. Rather than having numerous portals for data delivery and comms, everything is streamlined into a ‘single source of truth.’ Ultimately, less effort and fewer resources are required – particularly when standards are reused.

Speed drugs to market with earlier decision making

With reusable standards for vendor data collection, and the ability to get clean data reviewed faster, analysis is brought forward and informed decisions can be made far earlier. As a result, sponsors can launch new life-changing medicines and start reaping the benefits faster than ever before.