Case Study: Atrial Fibrillation Phase III Service Extension


Background:

European Phase III Study in Atrial Fibrillation.  Dokumeds originally contracted as regional CRO for 4 Nordic and CEE countries.  A further 8 countries were initially managed by additional regional CROs.

Situation/Solution:

Dokumeds achieved milestone on time or early during Site Startup and Initiation, and Recruitment periods, and exceeded local enrolment commitments by 19%.

After 1 year, Sponsor requested Dokumeds to take over all services from regional CRO from one additional country.

The following year, Sponsor requested Dokumeds to take over all services for an additional 7 countries.

Outcome:

Dokumeds managed an organized and controlled handover, and concluded the study within the adjusted rescue parameters set by the sponsor.


Dokumeds Latvia
Alojas iela 6
Riga, LV-1013, Latvia

Contact@ dokumeds.com

Phone: +371 67 553 065

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