The Medpace Approach to
Decentralized Clinical Trials (DCTs)
Clinical development continues to become increasingly complex- each study contains its own unique set of challenges and nuances. Rather than a “one size fits all” approach, Medpace offers our Sponsors customized programs designed to achieve your study’s objectives and timelines. As part of this tailored approach, Medpace offers a suite of DCT capabilities that provide additional tools to help keep studies on track and on budget, while providing greater flexibility and support for Sponsors, sites and patients.
Advantages of Medpace’s DCT offerings include:
- Expanded and expedited patient recruitment
- Improved patient retention
- Reduced burden to both patient and sites
- Enhanced timeliness of data collection and patient/site interactions
- Improved overall compliance
Nearly all current Medpace studies, across all therapeutic areas, leverage DCT offerings to some extent. Through our proprietary technology suite, deep operational experience and know-how, and key partnerships, the team at Medpace can incorporate the right elements of decentralized/hybrid trials to tailor a best-fit trial design to your program’s objectives and position your trial for success.
See How Medpace is Making the Complex Seamless®
with Tailored DCT Solutions
A patient’s ability to submit their data is critical for successfully executing a decentralized or hybrid clinical trial. TrialPACE® ePRO/eCOA/eDiary collects responses directly from patients through multiple platforms. Patients can access the TrialPACE® app via their own mobile device for added convenience. This easy-to-use, yet sophisticated tool, increases active subject participation in the research. Patient-entered data is then immediately available in the ClinTrak® EDC database for analysis.
With eConsent, patients can complete the informed consent process electronically, adding convenience and flexibility. eConsent data and ICF forms are then seamlessly integrated into Clintrak®, Medpace’s proprietary trial management software, to help ensure complete and accurate recordkeeping and regulatory compliance.
Wearable biosensing technologies enable the continuous collection and real-time transmission of patient biomarker data. The aggregate health data can be used to monitor trial safety, assess efficacy, and provide other vital operational and analytical advantages. Our expert team can guide you through:
- Sensor selection, validation and logistics
- Providing secure data capture and integration into study records,
- Incorporating data review, analysis, and visualization to assist with regulatory submissions
Home Health & Telehealth Services
Home and telehealth services effectively bring the trial to the patient by allowing them to complete study visits from the comfort and convenience of their own home. Including home or telehealth visits in the trial design can expand the potential patient population, reduce the burden on both patients and sites, reduce trial enrollment timelines, and improve patient retention. Medpace has years of experience providing home health and telehealth services through partnerships with preferred providers.
Direct To/From Patient Services
A direct-to-patient (DtP) strategy can reduce patient and site burden by delivering the IP and other study supplies directly to the patients home. Clintrak® IRT directly facilitates DtP, integrating storage and shipments via a collection of preferred global partners, supporting multiple product types and allowing for customization at the site and country level.
Patient Engagement & Concierge Services
Medpace’s Patient Concierge Services Team offers a collection of customized services intended to create a more convenient, positive trial experience for the patient, including supporting patients with travel and trial-related expense reimbursements.
Medpace’s Patient Engagement Team is focused on the identification, implementation, and tracking of customized strategies to maximize patient recruitment success, including eRecruitment, an easy-to-use patient platform, and trial branding and advertising.
Site-specific plans manage and streamline each investigator’s approach for recruitment. Recruitment tactics are customized to the site’s level of research experience and available resources. Some of the solutions Medpace offers for sites are site portals in our ClinTrak® CTMS, site training services, and our OnPACE site app, which provides a clear overview of study assessments, access to study documentation such as the protocol and IB, and links to study websites.
Sites who have exceeded performance metrics such as expediting study start-up, rapidly enrolling quality patients, and delivering high-quality data may earn the status of a Medpace Flagship Site. These sites are experienced in supporting DCT approaches and are well-versed in Medpace technologies.
Timely collection, monitoring and evaluation of clinical data is critical to the success of any trial. Continuous centralized analysis of clinical data can ensure the proactive identification of quality, safety, and operational risks.
All primary sources of critical data are integrated so that large amounts of data can be reviewed in aggregate. Through our proprietary platform, we can shape and visualize data to identify trends, outliers and other points of interest. This level of real-time visibility into study data contributes to improved safety and operational oversight through actionable outputs to drive decision-making and control risk.