Q&A: Introducing Orbit Compliance Center

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Q&A: Introducing Orbit Compliance Center

AgilePV Introduces Orbit, a new platform that’s flexible, validated and intuitive.

Perfect for Tracking:

·         Risk Management Plans, Commitments and Additional Risk Minimization Measures

·         Aggregate Report Generation and Submission

·         Safety Observations and Signals

·         Benefit Risk Evaluations

·         End-to-End Label Updates

To introduce the new platform, we’ve decided to post a Q&A on the new Tracker with AgilePV’s President, Dan Feith:

How does it work?

Orbit Compliance Center takes the same tracking tools we had with AgilePV– RMP Tracking and Signal Tracking — and delivers greater configurability and customization for our clients– with no coding required. For example, if you have a spreadsheet where you’re tracking aggregate report delivery, who needs to do what and when….your current tracking spreadsheet doesn’t notify anyone of upcoming commitments, track changes to the spreadsheet itself, may be copied all over the organization, and can take weeks to get all participants to update in the event you are audited. With Orbit, all tracking information will be available online, with better data controls and everything you need to be audit ready… a full audit trail, automated notifications and metrics.

After many conversations with our clients, colleagues and friends, we’ve found that we can deliver much more value to Life Sciences through other trackers — not just PV. For example:

·         Visibility across tracking systems

·         Integration between tracking systems

·         Document Creation and Collaboration

·         Multi-Tenancy & CRO Friendliness

·         Integration with Master Data Management

Why would I need this?

You tell me! But really, our clients have showed us processes tracked by spreadsheets that they know should bevalidated but aren’t. That’s where we start.

What about effectiveness and efficiency?

These are questions we hear more and more these days. Orbit makes organizations more effective by providing more quality at data entry and an audit history of all changes. This leads to more effective reporting when audited. The same goes for efficiency. There is not just better data, but better processes to boot. Orbit is powered by workflow which can push tasks with deadlines to participants. This helps keep up with commitments and get work done.

Orbit is ideal for generating new integrations– tell us what you’re looking for and we can make it happen.  Existing integrations include homegrown systems, common Safety Databases, Authentication Providers, and other sources of valuable data help reduce data entry time and standardize data across systems. Once again, this leads to better reporting across the enterprise.

Well maybe you can solve those problems, but I have a very special and unique problem that would be too difficult for you.

Think you can stump us? Give me a call. We’ll have it to our clients this fall.

Daniel Feith