Integrated approach achieves early DBL for an adaptive design endocrinology trial

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Novotech was engaged as a full service contract research organization (CRO) in a multicenter phase I/II obesity treatment research program. Despite multiple challenges, we achieved key study milestones ahead of schedule due to a joint collaboration between Novotech’s clinical, regulatory, data management and biometrics teams.

The Background

Obesity levels are rising, with more people now overweight than undernourished, worldwide.

A US biotech sponsor appointed Novotech to complete a multi-center adaptive design phase I/II program to investigate weight reduction and safety in patients, using their new treatment for obesity. 

Novotech were engaged to provide full services - from clinical through to vendor management, data management and biometrics services.

The Challenge

There were several challenges on this Study:

  • Rapid on-boarding with sites pre-selected by the sponsor for the phase I study
  • Additional protocol amendments were required by the HREC to approve phase II of the study resulting in significant changes to CRF/data base design and laboratory processes
  • A change in Investigational Product strength identified during a safety review meeting required additional regulatory documentation for all sites
  • Requests for supplementary datasets to help secure investor funding for further clinical development programs
  • Strict timelines for key study milestones to achieve sponsor objectives.

Our Actions

To facilitate securing the dynamic timelines, Novotech reallocated and prioritized team resourcing within the project’s scope.

Novotech developed a competitive recruitment strategy for the phase II study that identified and supported dedicated sites to achieve rapid recruitment timelines. High-performing sites engaged in the program and in return were allocated a higher percentage of the overall enrolment target.

The Results

Data Base Lock and other key study milestones were achieved ahead of schedule due to a unified collaboration between Novotech’s clinical, regulatory, data management and biometrics teams and key stakeholders.

This outcome resulted in the sponsor securing investor funding for further clinical development of this product and pursuing growth initiatives.

In addition to these achievements, the sponsor praised Novotech for their open communication, responsiveness and risk management strategies and has since retained Novotech for a second global phase II study.