Case studies

Handling serious adverse events for complex clinical trial

Pharmacovigilance

Insight: 
Our client, an emerging pharmaceutical company, was conducting large Phase III trials for a last-line therapy to treat a progressive, life-threatening condition. Because the disease was so advanced, patients were taking up to 20 concomitant medications, had numerous concurrent illnesses. Patients were in the study for over one year. The client was still building its pharmacovigilance team and incoming serious adverse events were overwhelming their current resource. A backlog of 600 cases had been triaged but not processed.

Idea:
Ashfield Pharmacovigilance, whose services are delivered by Ashfield company Drug Safety Alliance, focused on the backlog, freeing the client to focus on new cases. We brought in experienced pharmacovigilance and drug development scientists, expanding the staff resource. We also hired data-entry staff to handle the large volume of data.

Impact:
We processed the entire backlog within 10 weeks. The scientists completed the cases 25% faster, while time-consuming data entry was completed by lower-cost staff. The client was so confident in our work that they also asked us to handle some of their new cases so they could meet their deadline.

How this helped patients
By helping our client process the results of this complex but hugely important trial, we enabled the client to make the next step in bringing their new treatment to the seriously ill patients who need it.

Reflecting our values
• Partnership: We worked closely with the client to support them through a crucial trial.
• Quality: We achieved and exceeded deadlines using flexible, high-quality staff.
• Expertise: Our expertise enabled us to roll out a highly effective project for the client.
• Ingenuity: By using the right combination of scientists and data-entry staff, we minimised the time and cost needed to complete the project, while enhancing quality.

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