Rescue Studies

Is your clinical study at risk? Let’s get it back on track. Together.

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There are a number of reasons why a clinical study may run off course.

If you’re experiencing one or more of these red flags with your current provider, it’s time to contact Premier Research.
Stalled patient enrollment

Stalled patient enrollment

Staff turnover

Staff turnover

Inadequate patient retention

Inadequate patient retention

Unsatisfactory communication

Unsatisfactory communication

Insufficient coordination of vendors

Insufficient coordination of vendors

Missed milestones in study start-up

Missed milestones in study start-up

Subpar tools and technology

Subpar tools and technology

Delays in data cleaning

Delays in data cleaning

 

Rescue studies can be challenging, and you need assurances that transitions will be smooth. Meet ASIST.

Premier Research understands the importance of defining operating procedures to guide the transition, and have mobilized resources whose sole focus is on supporting the process. Premier’s Advanced Study Integrity Services Team (ASIST) is dedicated to analyzing issues, defining strategies, and developing a recovery plan for at-risk studies, all driven by our documented SOPs.

Our rescue study experts stand ready to partner with you through:
  • Assessing your trial’s status and the challenges you’re facing
  • Identifying the issues standing in the way of success
  • Developing a plan to put the project back on schedule
  • Leveraging ePremier, our in house study management technology platform, to perform an assessment pre-transition and enable a seamless handover of responsibilities
  • Making technical recommendations that address study-specific challenges
The best predictor of future success is previous success. See our rescue studies in action below.

PREMIER INSIGHT 283

Rescuing a Phase 1 Oncology Trial: Long-Standing Experience Saves Study Momentum

When a sponsor of a novel oncology therapy contacted Premier Research, they were more than a year into their study and experiencing many issues. Premier’s extensive history in transitioning studies, combined with our oncology expertise, came to the rescue and got the study back on track.

PREMIER PERSPECTIVES

Site Selection, Manufacturing & Long-Term Follow-Up: Looming Challenges for a Rescue Phase 1/2 Gene Therapy Trial

This case study is based on Premier Research’s work operationalizing a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment.

Looking for something else?

For information about Premier Research’s in-house clinical development and consulting expertise or general requests, get in touch with us here.