Messages from Orbit

December 3, 2018

A New Years Resolution we can achieve in 2019

It’s not how much you CAN track, it’s how little you NEED to track At the beginning of each new project we work with our clients […]
September 17, 2018

Why is everyone so worried about their Additional RMMs?

Additional Risk Minimization Measures are invaluable for mitigating drug-related risks that are both severe and preventable. Having aRMMs in place often improves patient outcomes, yet aRMMs […]
June 25, 2018

Orbit and GxP AnalytiX to deliver end-to-end signal management

PHILADELPHIA, PA – Orbit and GxPAnalytiX announced plans today to enter a partnership to deliver their Signal Detection, Signal Management, and Reconciliation tools as an end-to-end […]
April 11, 2018

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 […]
December 21, 2017

Happy New Year from AgilePV

Happy New Year to Patient Safety and Regulatory Professionals. You are responsible for massive amounts of data, and the stakes are high—yet every day you work […]
July 25, 2017

Patient Support Programs: Eating the Elephant

Across the board, Pharmaceutical companies are looking to reduce the amount of effort they put into case processing. Case processing comprises a huge amount of manual […]
July 7, 2017

Risk Minimization in Modules V & XVI – Show, Don’t Tell

Modules V and XVI are closely related regulations providing requirements for Risk Minimization Measures (RMMs) that you’ll need to account for in your RMPs.  Where Module […]
March 13, 2017

Tracking your Signals in EVDAS

So you found a potential safety signal in Eudravigilance EVDAS… what? The EMA recently introduced and made available (to MAH’s and national competent authorities) the Eudravigilance […]
February 27, 2017

Case Processing Evolution – Where do you fit?

In a webinar I gave last week, “Over Outlook? Simplify your PV mailbox with NLP technology,” I introduced a scale that I call “Case Processing Evolution.” These […]
February 13, 2017

Validated computer systems – a must for life sciences

For leaders in Pharma looking to implement a technology solution, one of the first considerations is validation—Can the system be validated, should it be validated, and […]