Phase IV Project Rescue

lient: Major franchise of a large pharmaceutical organization

Dyad was contacted to save two Phase IV post-marketing studies related to Chronic Kidney Disease (CKD). A sponsor was increasingly falling behind schedule due to low patient enrollment. At stake, were two multi-year studies on an approved drug that generates billions of dollars in yearly revenue.

Solution
Dyad's first step was to conduct an assessment to determine the cause of poor patient enrollment and site recruitment. Dyad concluded that poor patient recruitment was symptomatic of underlying clinical design and operational issues. Dyad immediately formulated a 60-day action plan to quickly address the underlying issues. The plan involved an all-hands-on-deck commitment from the sponsor's internal resources, CRO executive management and staff, and clinical sites.

Underlying Issues Poor Site Qualification Weak relationships with clinical sites Lack of CRA Accountability Unrealistic protocol exclusion criteria Lack of Principal Investigator support and involvement Competition from other CKD trials

DYAD Action Plan Establishing an improved site qualification and stratification process Formalizing the site communication process Amending the protocol Coordinating the effort with Sponsor's field reps to increase trial awareness at each site Developing forums for more active Principal Investigator involvement Shoring up project management controls for the study

Dyad was able to deliver seamless initiatives that worked without disrupting the study progress. As a result, the overall study design benefited:

1. Patient enrollment rates doubled within 60 days of the assessment
2. More qualified site identification resulted in higher enrolling sites
3. Sponsor developed a greater and deeper relationship with medical PIs
4. Instilled CRO accountability and project management oversight
5. Improved Sponsor/CRO communication and metrics tracking