Case Study: Respiratory Disease: COPD Phase IIIB Recruitment Rescue


Case Study: Respiratory Disease: COPD Phase IIIB Recruitment Rescue

Background:

Global Study in COPD, with risk-based monitoring plan.  Dokumeds contracted for 10 countries in CEE, Western Europe – EU and non-EU countries. 119 Sites, Approx 2000 patients. Full study included additional regional CRO, for additional countries.

Situation/Solution:

Site Initiation and Recruitment start ahead of plan, despite start up in summer. Resources mobilized to maintain quality, and monitoring frequency. Additional effort from Sponsor to maintain IMP supply.

Dokumeds recruitment exceeded regional enrolment plan 5 months ahead of schedule.  In comparison, other regions were behind in enrolment.

Dokumeds managed countries re-opened, to rescue the recruitment, with an additional 100 patients screened and randomized within 15 days.

Outcome:

Dokumeds exceeded originally contracted patient commitment by 13%, upon request of sponsor, to maintain the LPO timelines for the study.


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

Contact@ dokumeds.com

Phone: +371 67 553 065

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