When Your Trial is Struggling… Trust the Best
Successfully conducted Endpoint Adjudication Committees add precision to endpoint reporting in clinical trials. However, adjudication processes can add a level of complexity into trial conduct that is best managed by teams with expertise in the space.
Many sponsors face challenges around their Adjudication committees but cannot necessarily pinpoint the causes. We are on standby to help. Our familiarity with adjudication nuances enables WCG to partner with clients to conduct an assessment, identify gaps and risks, and develop the best transition plan forward for the Sponsor.
Top Reasons Clients Transition EAC Work to Us
- Scaling Challenges
Higher volume of events, manual processes, higher burden placed on Sponsor team.
- Decision Analysis Impact
High rate of non-assessable decisions, delay providing adjudication results to the DMC, duplicate decision results, lack of Sponsor insight into adjudication results.
- Adjudication Technology System
Inability to assess adjudication results, site or CRA obstacles reporting relevant materials for EAC, delays in moving events through the adjudication process.
Our Approach to Rescues
- WCG engages with Sponsor team and EAC members to begin assessment.
- WCG presents transition plan and recommendations to Sponsor and adjudication committee.
- Customized AIMS adjudication system based on protocol, analysis needs, Sponsor and EAC member input, addressing previous pain points
- EAC member contracting, if needed, and EAC meeting planning to finalize Charter amendments
- Working backwards from critical study timelines and anticipated first batch of subjects
Our Unmatched Experience
- 30+ supported EAC rescues
- 100% repeat business from our rescue clients
- 98% of existing EAC members maintained
- 100% of previously adjudicated event decisions maintained
- 16 day average for reduced adjudication turnaround time
Sponsor In-house Rescue Challenges
Sponsor was managing their EAC in-house during Phase 2 with a lower number of events and unable to scale. As they moved into Phase 3, the administrative burden became too high and there was potential conflict due to sponsor/member relationships and interactions.
CRO Rescue Challenges
There was high turnover within the CRO, a lack of access to timely decision results, a backlog of decision results, and quality concerns.
Competitor Rescue Challenges
This was an administrative model that didn’t seem to utilize
technology, and had a lack of record keeping, limited member network, unresponsive project managers and high turnover.
Contact us today to see how the industry’s most trusted EAC partner can help provide transparency, scientific rigor, and precision for your clinical trial.