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Simple effectiveness study deploys electronic data capture solution despite tight timelines

Pharma company benefits from enhanced data quality in late phase study.

Summary

  • Simple data capture solution required
  • Tight timelines drove initial decision to use paper
  • However, configurable electronic platform enabled timelines to be met

Impact

  • Total delivery time less than 2 months from kick-off to go-live
  • Enabled client to benefit from electronic data capture
  • Met client’s regulatory and budget expectations

Situation

A pharma company needed to conduct a year-long study involving 500 patients to assess the effectiveness of a smoking cessation product. The challenge was to find a robust data capture solution which could be launched within a period of just two months.

Even though the client recognized the benefits electronic data capture would bring, they assumed it would not be feasible given their schedule and low budget. It was therefore felt that a paper-based solution would be the only viable option.

Solution

The client took advantage of Clario’s configurable Post-Approval platform, which significantly reduced the delivery time from kick-off to go-live. The solution itself consisted of a native app (iOS and android) that was delivered to the patient’s own smartphone and, where necessary, included provisioned devices. Reminders and alerts were built-in for both patients and investigators to help retain patients and prompt them when assessment windows were open. A reporting module also gave the study team real-time access to data and study insights.

Our client was delighted that we could deliver an electronic solution so rapidly. It meant they could avoid all the downsides of using paper diaries and take advantage of all the upsides of collecting data electronically.

Matt McCarty
Chief Strategy and Marketing Officer, Clario

Impact

Clario’s Post-Approval platform enabled a BYOD data capture solution to be delivered to the client in less than two months, making it possible for them to meet their first-patient-in deadline. Importantly, they were also able to take advantage of the benefits associated with capturing data electronically—including enhanced data quality as well as real-time insights into study progress and retention rates, while meeting regulatory and budget expectations.

Enhance data quality for post-approval studies with electronic data capture.