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PCG Clinical Service News
BackFebruary 8, Uppsala, Sweden

Viedoc Master Users - Case Study

Master Viedoc Users

Unlike no other CRO, PCG Clinical Services has been using Viedoc (our eCRF system) since its creation in 2003. We have performed over 300 Viedoc trials in 27 countries and 22 different therapy areas. As one of the largest and most experienced CRO´s using Viedoc, PCG has been instrumental in its development over the years. Mapping our customers’ needs through Viedoc is a task we have been fine-tuning for 15 years. Our customers, especially our repeat customers, heavily rely on PCG´s experienced staff and expertise as Viedoc Master Users. This proficient knowledge helps the setup and performance of the clinical trial in the most cost-effective and efficient manner.
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Trial Objectives:

A phase III clinical trial with 300+ patients across 30 sites in ten (10) European countries. The main objective was to get ultrasound video clips to an independent reviewer in due time as part of the inclusion criteria and the efficacy parameter. All sites were required to send ultrasound video clips to the reviewer so that he/she could make critical measurements in the ultrasound clips and give the site's feedback on whether the patients met the inclusion criteria, or not.

Challenges:

There were many logistical challenges ahead of the trial:

  • The investigator sites were not experienced in operating ultrasound machines, yet the recording was crucial, not only once, but several times for each patient.
  • The site staff recording the ultrasound clips were not accustomed to making the specified type of measurements. To keep all measurements standardized, the clips were to be made by one objective reviewer for all patients in the trial.
  • The information was needed quickly to know if the patients met the inclusion criteria.
  • The option to send ultrasound video clips across Europe (by post) was considered too expensive and slow.
  • The client was concerned about losing track of the videos sent and received.

PCG’s solution:

Instead of sending videos by post across Europe, the clips were uploaded to our modern electronic data capture (EDC) system, Viedoc. The client, fortunately, had already chosen Viedoc as the EDC system in the trial. Through a customized and fine-tuned setup, we were able to accomplish the entire below process within Viedoc:

· The “US operator” (at the sites) was invited to the screening visit with the patient, recorded the video and uploaded it to Viedoc.

· The “US reviewer” (the independent reviewer) received an email stating new clips were available for review.

· The US reviewer logged in to Viedoc and could then view and measure the clips from his/her account.

· The outcome of the review was documented in the CRF forms by the US reviewer.

· The documentation of the review automatically triggered an email alert, sent to the investigator, stating that the patient was either eligible or ineligible for inclusion. The reviewer could even state that the video was of too low quality – this would also trigger an email back to the US operator (the site) to request a new recording to be made.

· In addition, the system was set up in 3 different languages to accommodate local needs. Meaning that the Viedoc user would access the information in their own language.

In total, the entire chain was accomplished directly through Viedoc during the trial. No shipment/postage was needed to send the video clips, nor any delays were incurred due to outdated practices. All decisions and files were documented within the Viedoc system.

The setup required email triggers, file upload fields, and user role customization.

Viedoc is very dynamic and when used to its full potential can be customized to fulfill your needs!

Benefits of PCG’s solution

As master Viedoc users, the customer benefited from the knowledge and experience we have with Viedoc. By understanding the full potential and ability of Viedoc´s technology, PCG managed to solve the logistic challenges of this phase III clinical trial. For the client, we saved a substantial cost, provided data in real time, and made the entire trial progress much smoother.

The client returned to PCG for their next clinical trial.