HomeResource LibraryBionical Emas Global Clinical Operations: Rescue Study
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At Bionical Emas we have extensive experience in all phases of clinical trials, from first in man through to post-marketing surveillance. We can manage the entire process, enabling complete outsourcing of a clinical development program. One of the areas in which we specialise, is the rescue of studies, where other CROs have failed to deliver.

Situation.

Our client is a US based biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies, intended to significantly improve outcomes in patients suffering from life-threatening diseases. Bionical Emas Clinical Development, were brought on board to rescue a complex pivotal phase III study, for the treatment of patients with distributive or vasodilatory shock.

The sponsor had initially selected a large CRO, as the clinical operations vendor, because of their “global capabilities”. After failing to meet any key milestones the sponsor took-action, removing the existing CRO from all Rest Of World (ROW) activities.

Through the completion of a robust feasibility, Bionical Emas were able to identify and propose 14 countries and appropriate sites that would eventually participate in the study delivering the patients and the data that was required. Bionical Emas delivered site setup ahead of agreed timelines.

Despite now focussing solely on the US clinical start-up activities, the incumbent CRO continued to fall behind schedule. Bionical Emas were requested to onboard a CRA SWAT team to support start-up activities in the US. The sponsor took further action and within six weeks Bionical Emas replaced the existing CRO in the US entirely. To ensure handover and execution was seamless, Bionical Emas completed a thorough scoping exercise, resulting in a gap analysis and implementation plan to ultimately steer the study back on course.

Approach.

  • Through the provision of a highly experienced clinical team, a dedicated executive leadership team and alignment with the sponsors clinical goals and strategic ambitions Bionical Emas successfully delivered this pivotal study ahead of schedule.
  • A deep understanding of the complex challenges that surround rescue studies was paramount to developing meaningful strategies for the delivery of effective clinical operations solutions. A lot of preparation and deep thinking went into conducting a gap analysis, risk mitigation strategies and an implementation plan to ultimately ensure that operational delivery was as seamless as possible.
  • We provided our client with “feet on the ground” through a highly skilled global CRA resource with deep expertise in critical care.
  • Our well established CRA network enabled us to bring on additional resource when and where required. Our flexible structure enabled us to provide a CRA SWAT team within a very short space of time to conduct robust feasibility, leading to the selection of the right sites with access to the right patient population.
  • Our CRA SWAT teams were selected based on their existing relationships with sites, working directly with the Contract and Legal teams at the institutions to ensure that clinical trial agreements were executed swiftly and start-up times could be reduced.

Outcomes.

  • Through the expeditious start-up process Bionical Emas managed to recruit all 315 patients to the study 6 weeks ahead of schedule. The study was opened in a total of 15 countries with 115 sites globally.
  • The quality and robustness of the data from a well-executed study meant that the filed NDA was approved by the FDA.
  • The product is now available and provides a significant benefit to a vulnerable and under-serviced patient population.
  • This was the fastest ever recruiting shock study.
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Clinical Development

At Bionical Emas we understand that individual biotech and pharma companies have very different needs. All our clinical development services can be tailored to meet those individual requirements. From a standalone service, to a fully integrated large global clinical trial, the Bionical Emas team, has the expertise and experience to support and deliver our clients clinical development plans.

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