Why PHT?
ePRO solutions offer proven benefits to clinical research. While it may initially seem difficult to differentiate between providers, closer examination of critical success factors (e.g. product features, quality system, eDiary design, study support, global logistics management and technical security standards) provides insight into why more sponsors trust PHT over any other provider to collect and manage their PRO data.
Experience Means Proven Results
Our ePRO solutions are the most used in the world - which means we have successfully developed eDiary designs to address numerous challenges across all therapeutic areas. This in-depth experience assures sponsors that PHT understands unique trial needs and will create a custom ePRO solution to enable their science.
Passionate About Preserving Data
Since our inception, PHT has worked closely with third-party technology providers and Palm OS engineers to invent advanced methods for preventing data tampering or loss of any kind. Our superior technical architecture features protection against a device hard reset or battery loss, while our Three-Phase Commit security best practices ensure that data is always stored in at least three redundant locations from the moment it is received. In addition, we leverage unique programming into embedded Flash memory to preserve application and data integrity.
Study Support Center (SSC)
When working with a technology system, no matter how proven or well-designed, unexpected issues may arise. PHT realizes that there will be questions during the trial - and we are ready to answer them, 24x7, with our internal multilingual Study Support Center. Our SSC is staffed exclusively with PHT experts trained in the details of every active client study, which results in over 95% of issues being resolved on the first call. The SSC is one of PHT's strongest and most valued services among our client base.
Technical Leadership
PHT offers a series of unique features for your eDiary solution that our customers have come to expect and no other provider can match.
- Real-time Calculations and Alerts - The LogPad can use data from previous and current diaries to perform calculations, on the device and in real time, for randomization decisions or symptoms scores - as in the Temple COPD disease management study. These calculations can trigger action safety instructions (e.g. telling subjects to contact their site if a PEF score is too low), new question paths or arms for adaptive trials.
- Email Alerts - Another of PHT's exclusive ePRO features, StudyWorks can be configured to send real-time email and pager safety alerts to sponsors, sites and medical monitors in order to let them know that a subject requires immediate attention.
- Seamless Mid-Study Changes - PHT's systems feature two-way communication between the server and LogPads in the field, enabling sponsors to update all devices anywhere in the world with mid-study changes - without requiring subjects to return to the site.
- Total Device Flexibility - PHT's exclusive SimpleSend Wireless Pak is the only GPRS/GSM sled that transforms an analog Palm device into a mobile and wireless one. Along with our other SimpleSend options, PHT allows sponsors to choose from the widest available range of device and transmission options without sacrificing ease of use, mobility or device consistency worldwide.
- Site-to-Subject Messaging - PHT is the only ePRO provider to offer site-to-subject device messaging. Messages are sent out of StudyWorks to remind patients about visit schedules or to encourage compliance, and are included in the Study Archive audit trail.
ISO Certification
PHT is the only handheld eDiary provider to achieve ISO certification. Independent certification of our quality management system assures sponsors that we do what our SOPs say we do, that we are always improving, and that PHT is a trustworthy provider - which is especially important in a highly regulated industry.
Study Archive
PHT's service does not end just because your trial does. Our world-class Study Archive, delivered to sponsors and sites on special durable CD- and DVD-ROM media, is the undisputed best-of-breed industry standard. Unique in its use of XML source and metadata, complete with all signatures, audit trails and permissions, it meets and exceeds strict FDA and EMEA regulations for data retention and trial reconstruction.
Learn More about the PHT Difference
What experience and best practices do you have in my therapeutic area? What other technical innovations and processes are unique to PHT? Contact PHT for answers to these questions or any others you may have.
