Challenges
Our Sponsor cited the following experiences in recent studies:
Extended set-up phase due to fragmented approach displayed by various global CROs.
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General poor site engagement and passive recruitment in part due to site resource limitations as a result of competition with CTIMP studies.
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Deployment of an inefficient EDC system, resulting in poor data quality.
Solutions
O4 Research supported Steering Committee meetings, co-developed the study concept with our client prior to authoring the protocol and expedited approval from the joint Market Authorisation Holders. Rapid set-up and an efficient patient recruitment phase was achieved by:
Adopting a patient centric approach to the study from the outset and involving a patient advocacy group to seek opinion and feedback.
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Availing of O4’s AccelerateTM to optimise study start up processes and drive enrolment phase timelines, achieving First Site Activation 4 weeks from issuing the first ‘Local Study Packs’ for R&D site team review.
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Deploying O4 EngageTM to significantly increase the study profile by establishing a unique study identity that extended across all key communications and significantly increased study visibility and resonated with site staff and patients alike.
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Designing an intuitive EDC system, incorporating input from the end users, which encouraged real-time data entry and ensured that data quality was optimised.
Impact
This study is characterised by strong engagement, demonstrated by widespread positive feedback from both patients and study teams, high recruitment and exceptional patient retention. The overall outcome of which is a rich dataset including > 95% of key endpoint data.