Outcome Monitoring

We have European coverage in the home or in clinical setting for outcome monitoring and controlled data collation. That includes pharmacovigilance reporting, patient safety follow ups, and real-world evidence for extensions, reimbursement approval, and contribution to registries.

Seamless data capture

We collect outcome monitoring data in lots of different ways to ensure the most comprehensive data capture possible. That includes either directly through our nurses and our patients, or remotely via wearable devices and the easy to use app and patient portal. This combined service means we can provide useful, regulatory-compliant and controlled data in a way that works seamlessly for everyone involved.

Our combined data capture service

Our easy to use app and patient portal will be tailored to the requirements of your company, products and your patients delivering useful, regulatory compliant controlled data.

  • Patient pathway – home or dual underpinned by nursing specialists
  • 24-hour multilingual care bureau patient service
  • Data metrics at home – BP / temperature / respiratory / heart rate / wearable integration
  • Quality of life assessment adherence, family support
  • Patient behavioural and psychological support
  • Regulatory compliant analytics and reporting

“Our experienced pharmacovigilance team ensures all adverse effects (AEs) are reported. In the last year, we’ve reported 219,000 adverse events, managed 10,600 product quality complaints, and achieved 100% compliance with reporting requirements.”

Reporting Adverse Events

The safety of patients is our top priority, so we closely monitor and report on all side effects and non-compliance with medication at all times. We also have many ways of reporting adverse events to ensure patient safety including in person, to our nurses and over the phone – even to our delivery drivers.

  • Document adverse events in incident and complaint module in CRM Patient Record via desktop or laptop
  • Customer & Patient Services (CPS) staff contact via telephone, email and mail
  • Direct contact or telephone, email or mail. Drivers and other staff (e.g Commercial or Finance) with no access to CRM Patient Record
  • Clinical staff direct contact or via telephone, email or mail
  • Via intermediary with access to CRM or where applicable by using a patient information card which recommends contact with CPS
  • Pharmacy staff contact by telephone, email and mail
  • Logistic Support and Prescription Management staff contact by telephone, email and mail

A complete solution across the drug lifecycle

We offer a fully managed service across the drug lifecycle, designed to meet the specific challenges of launching and delivering orphan drugs for rare and ultra rare diseases to patients in Europe & beyond.

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