Improving the Site & Patient Experience by Centralizing Trial Services
Over the past year, it has become more evident that clinical trial conduct has become more complex, and from that a new strategy has to be considered in order for the acceleration of new therapies to continue down the current course. While there have always been challenges associated with any clinical trial, our industry has been pushed to rapidly evolve in order to overcome the challenges that we’ve experienced.
From protocol design to site management to patient services, every aspect of the clinical trial process has been affected. Thankfully, many of the solutions required for flexible and creative usage already exist, and are being rapidly adopted across the board. The strategic model being introduced in this blog is designed to improve the experience of your most important assets – your sites and your patients.
Our Mission for the New Model
At any given time there are too many “cooks in the kitchen.” Too many companies, people, and vendors interacting with the site and patient at any given time, not to mention how many other parties the CRA is working with over the course of a study. When the most valuable role players are constantly being pulled in every direction, they get taken away from their main focus – whether it be CRAs to ensure compliance and validate data, or sites to enroll patients and follow protocol, or even patients themselves, who are expected to complete their clinical trial safely and efficiently.
ClinEdge’s main focus is to create site and patient-centric clinical trials to benefit all stakeholders involved – the sponsor, CRO, site, and patient. Our newly developed model drives our mission in the form of a community of services and vendors, centralized through people, and a platform.
We have chosen to separate the site and patient outsourcing from the clinical and data ecosystem in order to sharpen our focus on study coordinators that have historically been overwhelmed and patients that have been put through an unpleasant clinical trial experience. Under the new model, we have seen strong site and sponsor communication, optimized trial workflows on the site level and happier patients.
The Site & Patient Community
Under this new model, sponsors, CRAs, study coordinators, and patients will be provided direct access to one another via a single platform, and a single role to streamline various activities.
The Patient Ecosystem is a single platform and person for patient services. With this platform patients will be able to interact with a single point-of-contact from the day of their screening through enrollment , and throughout their travel or home trial experience for the duration of the study. Likewise, patients will be provided a patient portal for study communications/updates, retention purposes, travel requests, reimbursement submissions, and general study information.
For sites, a single point-of-contact will be responsible for all interactions with the site relative to support in our patient ecosystem. The site role will provide guidance and ensure accountability of patient recruitment efforts (including tracking/reporting for site to track progress and take proactive action if needed), meet regularly to discuss recruitment/retention plans via regular webinars, share data that may be helpful to the site, and help with validation of travel and reimbursement.
A Central Role
For Sites
The “Site Clinical Trial Manager” would be the central role for your ‘people’ in the site community. The Site Clinical Trial Manager (Site CTM) would function as the main liaison interacting with your sites to keep vendors and site activities channeled through a single contact. By funnelling site selection, start-up, patient recruitment updates, regulatory support, homecare visit coordination, retention/compliance management, and financials through one person, the study coordinator has a dedicated resource for deliverables and questions.
As you can imagine, appointing a dedicated point of contact for the site will facilitate a strong working relationship that can be repeated over time, across multiple studies. Likewise, the site CTM is a resource for the sponsor/CRO for any and all updates regarding this site, who also benefit from the strong relationship and allowing you to focus on data.
For Patients
As a result of the new patient ecosystem, a new role can be introduced to provide thorough service to our patients. By focusing study pre-screening/screenings, retention support, transportation assistance, reimbursements, and remote visit coordination through our Patient Navigator, the patient experience is greatly improved by the resulting trust in working with their dedicated navigator.
Technology Platform for Sites & Patients
The past year has been an agent of change to digitize clinical trials as much as possible, and the subject of the outsourcing model should be no different. The new site and patient model would need to be powered by technology that allows sponsors and CROs to manage patient services, site trial process, and clinical trial vendors at the site level to develop the needed workflows. The platform is integrated at the site level – meaning that study coordinators will have access to view vendor status, trial supplies, and patient services in one place. The internal project team at the sponsor/CRO level would administer this portal and automate processes across vendors to capture, communicate, and execute on deliverables.
Sponsor Portal
The sponsor/CRO platform environment in the site and patient community puts you right on the ground level. The portal has many sub-portals that allow you to track a site from feasibility through site selection, report on start-up timelines, through enrollment. As for patient services, the sponsor/CRO would see detailed reporting on advertising and marketing lead generation, ROI, web traffic for ads and websites, and call tracking to categorize lead source. Another extension is the travel portal to track and approve transportation requests, as well as reimbursement submissions by patients. You can also incorporate dashboards for financial reporting (sites), budgeting, and home trial source activity. The Sponsor/CRO dashboard can also be simplified and customized on a per trial basis to manage all site and patient activity.
A Proven Solution
As trial complexities develop, sites and patients are becoming overwhelmed with the volume of vendors. Without ownership of trial services, the burden falls on the sponsor, sites, and patients to interact with multiple vendors on any given trial. Our solution is to create a site and patient community funneled through a dedicated point-of-contact for the site, and for the patient as well the implementation of a trial operating system that houses sponsor’s internal environment within a platform.
To learn more, contact us today.