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Familial Amyloid Polyneuropathy

PHASE 3

Case Studies

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Key Takeaways

BBK Worldwide was engaged by a leading pharmaceutical company for more than six years to provide clinical study travel and reimbursement services for patients with familial amyloid polyneuropathy, a rare, inherited and progressive disease.

While our initial engagement focused on reimbursement, it expanded to include travel and then concluded with the introduction of medication delivery to support patients impacted by COVID-19 lockdown measures.

comprehensive travel and reimbursement
  • Participants_ICON 184 ENROLLED PATIENTS

  • Sites_ICON 24 SITES

  • Countries-ICON-1 9 COUNTRIES

The combination of services removed administrative burden for study staff while it created an optimal patient experience that succeeded in keeping patients engaged for the duration of the study.

Challenges

  • Complex itineraries for patients traveling a significant distance to study sites

  • Cross-border travel with knowledge of entry requirements and documents

  • Securing aisle seats near the lavatory for patients traveling by air

  • Coordinating travel for caregivers that aligned with patients’ itineraries

  • Arranging car service in neighborhoods where standard taxi services were not operating

  • Shifting rapidly to medication delivery in response to COVID-19 lockdown measures









global support
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Solution and Impact:
Medication Delivery

In the final year of BBK’s engagement, COVID-19 proved to be an unexpected challenge. It required a quick pivot to a solution that would support patients who needed to remain at home during lockdown. With speed and dexterity, we implemented our medication delivery service. 

Medication was packaged at the site and then shipped directly to patients’ homes using ground and air methods. The shipments needed to be temperature-controlled between 2 and 8 degrees Celsius and ready for patients to self-administer upon delivery. The success of this program ensured that study participants were able to remain compliant with the protocol and that the sponsor was able to complete the study as planned.

 

  • 2 SITES SUPPORTED IN BRAZIL

  • 11 PATIENTS

  • 18 MEDICATION DELIVERIES

Medication Delivery and Decentralized Study Support

Impact: Travel and Reimbursement

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4,561 Reimbursements

 

Reimbursement categories: meals, mileage, parking, lodging, ground transport, airfare, COVID-19 tests



6 COUNTRIES   |   15 SITES

Argentina, Brazil, France, Spain, UK, US

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863 Trips

 

1,606 itineraries translated into French, Portuguese and Spanish

 

4 COUNTRIES   |   7 SITES

Argentina, Brazil, France, US

 

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