PDH powers “Next Generation” clinical research providing a platform to lower drug development costs and expand patient treatment access. Our SUMMA™ platform provides a highly configurable, regulatory compliant, end-to-end solution to integrate and link patient, device and clinical data for advanced analytics and clinical trials. Unparalleled interoperability allows PDH to build core eClinical trial connectors, enabling complex trial models that continue to expand, and orchestrate the most complex, innovative modern research workflows.
Designed and developed with patient and data security as its foundation to meet today’s global regulatory and compliance requirements.
Typically, a DCT model is remote and siteless with very little if any physical contact between clinicians and patients. This model features eConsent/enrollment, eCOA and remote digital data capture. DCT’s promote a patient-centric approach while reducing cost and removing site burden. PDH serves as hub to facilitate multi-modal communications and end to end support.
More traditional site managed trials are preferred when a population requires clinical oversight. SUMMA’s site portal offers a streamlined experience to reduce site burden. It features data and safety surveillance as well as reporting and analytic datasets (SDTM/CDISC) for FDA submission.
RWE trial model becomes important when clinical trials cannot account for the total patient population, data is needed for future research, or real-world practices and patterns are of interest. To enable the RWE model PDH integrates and harmonizes various real-world data sources such as ePRO, electronic health records (EHR), claims, medical device and historical patient data.
This trial model incorporates digital health technologies to remotely collect supplemental physiological and lifestyle data points. Our mobile app allows streamlined patient experience encouraging compliance and engagement to support DCTs. Customizable portals are also available for site staff to access device data, reporting and compliance tracking.
A hybrid model assumes any combination of traditional and decentralized trial elements and can include both direct to patient, DCT elements and site managed components. PDH offers flexible scenarios that accommodate any level of technology enablement and clinical supervision to facilitate a nuanced study design.
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