"It is critical that sites understand not only how, but also why they should use this technology. From a sponsor's point of view, ePRO can improve data quality. But, it can also make life easier for sites … (It allows) sites to take direct action, such as calling a non-compliant subject before the issue began to affect the outcome of the trial."

Kevin Bayer
Former Clinical Development Coordinator
Orphan Medical

Read more on what people are saying about PHT.

The Site Perspective

Sites are the cornerstone of clinical research. eClinical technologies should make sites' jobs easier - not harder. PHT regularly conducts in-person interviews with principal investigators, study coordinators and other site personnel around the world who have used our ePRO systems in order to understand their responsibilities and requirements. We listen to sites and design our products with them in mind focusing on durability and ease of use. Review PHT Insights (Q4, 2006) for an insightful look into how sites feel about using ePRO - good and bad - in clinical research worldwide.

What Sites are Saying

In addition to on-site interviews conducted by PHT throughout the United States and Europe, two sites in the AIR2 Trial, sponsored by Asthmatx, took the time to discuss the benefits and challenges of using ePRO in a clinical study. Review the case study here.

Site Have Patients - Not Patience

PHT is committed to developing ePRO products that improve trial management efficiencies, enabling study coordinators to spend their time and attention on what they like best - helping patients.

  • Quality data - Sites say the best thing about using an ePRO solution is the improvement in data quality and legibility. Patients actually complete their diaries at the time specified in the protocol, and diaries filled out in the parking lot no longer exist
  • Real-time compliance reports - StudyWorks quickly identifies patients who need compliance encouragement or assistance, thereby helping sites proactively address any issues and save time later
  • Safety alerts - StudyWorks can be configured to send email alerts based on certain study or subject data to make safety monitoring more efficient (e.g. consistently low PEF scores or suicide warning signs. StudyWorks data summaries can also be used to highlight subjects experiencing worsening symptoms that require site follow up
  • Eligibility criteria - Subject performance during screening period can be calculated automatically for protocol-specific criteria. This helps sites identifies patients who are not fully vested in the study before they are enrolled and facilitates randomization decisions
  • eSource records with data quality controls - Properly formatted data eliminates time spent reviewing handwritten diaries for completeness, logic and legibility, or for AEs written in paper margins. Near-perfect responses minimize data cleanup and queries
  • Item scoring - Electronic input of scored data removes the need for double-data entry, which is often costly and time consuming
  • Fewer paper cuts - eSource records and our Study Archive mean sites no longer have to manage overwhelming volumes of paper binders

In Support of Your Sites

In addition to expert training and study-specific reference materials, PHT provides sites with 24x7 access to our internal, multilingual Study Support Center. The SSC is staffed exclusively with PHT experts trained in every active client study, and solves issues quickly -over 95% on the first call.

Do Sites Enjoy Using ePRO?

Study coordinators value eClinical technologies that free them to spend more time with their patients. Sites tell us the LogPad makes them feel…

  • Confident that data is in the proper format and done at the correct time
  • Relieved that they no longer have to review handwritten diaries
  • Focused on subjects and better able to monitor their safety and symptoms
  • Informed and in control of the trial - compliance data is real
  • Empowered (or required by the protocol) to encourage compliance
  • Pleased to enhance research reputation by using eClinical technologies

Training Made Easy

Because study coordinators train subjects on how to use the LogPad, it is critical that sites are thoroughly trained on the system prior to FPI. PHT takes a "train the trainer" approach, ensuring that sites and CRAs are experts on using the LogPad System for a given trial. Through site interviews and feedback surveys, PHT has found that sites reporting high satisfaction levels with their LogPad system training are those that understand not only how to use ePRO, but also why sponsors decided to use it in the trial. This is an integral part of every training session PHT delivers:

  • Investigator Meeting - PHT explains the value of ePRO, presents the LogPad screens to be used in the study, and provides hands-on demonstrations on how to use the eDiary and StudyWorks
  • WebEx sessions - PHT provides comprehensive, refresher or supplemental training via the Internet at the sponsor's request
  • eLearning and certifications - PHT's Web SiteLearning, an on-demand, online training program, offers standard and custom modules used either before the IM or prior to FPI. Each module concludes with an interactive certification exercise and sponsors can track individual utilization. It also facilitates training for new sites that join the study after the IM and for existing sites with new personnel

Reducing Readiness Risk

One of the primary issues in global trials is a lack of reliable telecommunications infrastructure. PHT offers Site Telecommunications Assessment testing services prior to the study start in order to provide an extra level of confidence to both the site and sponsor that PHT's ePRO solution will work efficiently and effectively.

Learn More about the Site Perspective

How do sites manage eDiary inventory? Are they able to train subjects effectively and how long does it take? Contact PHT for answers to these questions or any others you may have.

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