Resources and guidance for supporting employees, customers, and partners during this unprecedented health crisis.

  • October 5, 2020

Study Startup Expertise Supports our Global Customers Impacted by COVID-19

Sujay Jadhav
Global Vice President, Study Startup
This is a syndicated post, view the original post here

Thousands of clinical trials for new drugs and treatments are initiated every year around the world. The drug development process is complex, time consuming and expensive. Oracle’s study startup solutions track, manage and accelerate this process to help drugs get to patients faster. Global pharmaceutical and CRO companies, such as Pfizer, Merck, Amgen, Syneos Health, ICON and Covance rely on Oracle Health Sciences applications on a daily basis.

When the pandemic hit, it impacted all industries in a significant way. The effect on pharmaceutical companies and CROs was profound. Patients could not safely travel to clinics, doctor’s offices and hospitals where clinical trials take place. Eventually, shutdowns prevented doctors from seeing patients.

For many patients, a clinical trial is a last resort to solve a health problem. Participation in a trial is often the difference between life and death. Pharmaceutical and CRO companies immediately began to identify new ways of working while still adhering to the strict guidelines of local health officials and regulatory agencies. 

For the thousands of active clinical trials, mitigation plans were set. Clinical development teams needed to assess which trials would need to be delayed, others completely stopped, some prematurely ended. Depending on the disease and treatment, some doctors were able to pivot to virtual visits to evaluate their patients. The pandemic resulted in several changes to the clinical trial process in a matter of a few weeks:

  • Delayed the start of new/upcoming studies until COVID-19 was better understood and trial operations were safe to resume
  • Stopped certain trials entirely
  • Fast tracked new COVID-19 vaccine and treatment trials
  • Amended the study protocol, so study data could still be captured and monitored, ensuring the clinical trial data remained credible. This has often resulted in different implementations of virtual technologies.

Because many clinical trials are conducted in multiple countries simultaneously and the effects of COVID-19 varied geographically, clinical teams had to work together to quickly to assess the impact and establish a new plan. Managing in this environment is highly complex, yet critical when patient health and safety hang in the balance. Real-time information and analysis are critical. Oracle’s study startup solutions were are to provide this level of support for our customers.

In March, not long after the pandemic was spreading globally, Oracle created a study startup response team which developed and released several COVID-19 specific application enhancements to help our customers:

  • Workflows were modified to allow certain tasks to take place simultaneously. This was a critical enabler for COVID-19 specific therapeutics and vaccine studies where operational time savings were critical.
  • A new report was released to allow clinical trial teams assess the impact of COVID-19 related delays at the study, country and Investigator level (see below). This allowed pharmaceutical companies/CROs to better plan the revised schedules for studies along with the resource and financial impact the pandemic was having.
  • Support teams immediately prioritized all support requests related to COVID-19 clinical trials.

This agility is unique, which many customers have conveyed they have not seen from other technology providers, even to this day. Currently, our study startup applications are supporting over 50 COVID-19 vaccine and therapeutic clinical trials globally, with a median cycle time reduction for Essential Docs Sent to Site to IP Release for COVID specific therapeutic studies of 30 days, which is 76 days more efficient than the industry benchmark, and 34 days in COVID-19 specific vaccine studies, which is 50 days more efficient than the industry benchmark (Refer Fig 1)

Fig 1: Industry benchmarking report for COVID-19 specific therapeutic and vaccine studies

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