|
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|
|
Leveraging A Real-Time Patient Data Network
Accélère currently offers research sponsors and site-based research organizations a suite of patient recruitment services that leverages our core asset: a real-time patient data network, based on high technology infrastructure that extends into the secured data center of participating healthcare institutions.
Our Process
 Applying Accélère on a clinical study will contain four common stages. During the first stage, we conduct a pre-trial analysis, where we validate assumptions on applicability and operational capability based on an assessment we do with investigators and coordinators, along with any available retrospective data, at lead sites. In addition, we define the trial configuration requirements for our system based on input from the site's staff. In the second stage, we develop and deploy the trial configuration for staff at lead sites, while in parallel, we perform an assessment of all potential study sites to determine which ones are best suited to work with an Accélère system. Following the site assessment, we perform any site due diligence required to obtain HIPAA and operating agreements for each of the selected sites. In the third stage, we install and validate our infrastructure with each site's healthcare information systems and then deploy the trial configuration for its staff. In the last stage, we monitor, optimize and maintain our systems for the site-based research teams at each site until the enrollment goals have been met. The following section provides more detail on what services are performed at each stage. Service Descriptions
Pre-Trial Analysis Under the direction of the sponsor's medical director for the study AND the Primary Investigator (PI) and the study coordinator group at a lead site, Accélère validates applicability for using its recruitment system on a broad basis for a given study. Validation incorporates the examination of how key data elements are collected, data reporting response times, integration to standard of care process, and if possible, retrospective data analysis to assess screening evaluation windows and forecast possible screening/enrollment rates. In addition, we gather requirements necessary to design the trial configuration for real-time prospective screening and enrollment with the Accélère system. The requirements encompass the automatic screening scenarios, the electronic screening workflow and forms for each trial subject, and the content and format of the screening report and enrollment performance dashboard generated by our system for regular review. The resulting trial configuration requirements will represent the site's best practice for protocol screening during care delivery and form the basis for how other sites should perform recruitment. Trial Configuration Design / Lead Site Deployment Based on the requirements gathered during pre-trial analysis, Accélère designs and develops the trial configuration used for the Accélère system. We work with the investigators and study coordinators during the design process in order to ensure good system adoption when recruitment begins. After the configuration is tested and the users of the lead site approve its use, the trial configuration is deployed on the Accélère infrastructure at the lead site. During the first several months of enrollment, Accélère optimizes the trial configuration to minimize the screen to enroll ratio and user workload. The final, optimized trial configuration becomes the basis for deployment at other sites. Volume Deployment Assessment With the information gathered during pre-trial analysis along with direction from the sponsor and/or coordinating CRO, Accélère defines requirements for an ideal site that can generate the highest volumes of candidates with an Accélère system. Requirements may include 1) how key patient data is captured; 2) parameters surrounding how standard care is delivered; 3) willingness by staff to use new technology; 4) approval process for integrating Accelere infrastructure. These requirements become the key elements of a survey that is distributed and results gathered to generate a prioritized list of ideal deployment sites. Volume Deployment Approval Based on the list produced during volume deployment assessment, we visit each candidate site to meet the investigators, clinicians, coordinators and technology leaders and perform any due diligence required. During this visit, we also assess the technical requirements for installation and support of the Accélère system and begin to define a joint deployment plan to support the trial. We followup with the execution of a HIPAA Business Associate Agreement to access patient records and gain any IT or other hospital administration approval required for operating the Accélère infrastructure. Volume Deployment During this stage, Accélère coordinates the procurement, installation and support of its recruitment infrastructure at each site. Once an installation is validated with a site's health systems, we deploy the trial configuration developed and tuned in Stage 2A and make any site-specific modifications that are required. Lastly, we provision our system for the site's staff and train them on how to use it. Active Recruitment, Monitoring and Maintenance During active recruitment, Accélère maintains its infrastructure and supports the investigator and coordinator staff at each site for the entire length of the active enrollment period. As we gain operational experience on the given trial, we optimize the trial configuration in order to maximize overall recruitment performance, while minimizing work load for the site-based research staff. Accélère generates and coordinates any appropriate recruitment metrics reporting required by the sponsor and CRO across the supported sites, along with participation in any regular correspondence involving recruitment activity for the given sites. Protocol Applicability
Although the Accélère recruitment system would benefit most clinical studies by supporting a uniform, systematic and semi-automatic process to patient enrollment, the studies that have the biggest challenge with initial subject identification will benefit the most. In addition, there are a number of study attributes that we identify when we assess high-value applicability, including protocols that require:
|