Remote Clinical Trial Capabilities

The COVID-19 Pandemic is having a great impact on the planning, execution and management of clinical trials and will have a significant effect on the industry after the crisis has passed.

PharPoint Research is in the process of leveraging virtual and in-home subject visits, and remote monitoring capabilities services to support agile management of clinical trials. PharPoint’s approach will ensure the success of your clinical trial through nimble study strategy, adaptable monitoring strategies, efficient data flow, quality oversight of subject safety and swift study close-out.

 

Clinical Monitoring Strategies

Clinical trial monitoring activities have been impacted by restricted access to clinical facilities and restricted travel as a result of COVID-19.   PharPoint prides itself in providing our clients flexible monitoring solutions that allow their clinical research studies to continue despite these restrictions. PharPoint’s clinical monitoring strategies employ conventional, and remote approaches to clinical trial monitoring combined with in-house Data Review and Data Quality Management.

The monitoring team will conduct site qualification, site activation, interim monitoring visits and close out visits on site.

The monitoring team will conduct all monitoring activities, including site qualification, site activation and routine monitoring and closeout visits, remotely. These activities are accomplished utilizing web-based technology, accessing the site’s EMR remotely or enabling the site to redact and send paper source electronically to a secure location.

Clinical trial data are reviewed for discrepancies and the query generation and resolution processes are managed throughout the lifecycle of the clinical trial.  The process begins when subject data are entered into the database through database lock.

Subject Recruitment, Screening, Enrollment and Retention

PharPoint recognizes that COVID-19 will continue to impact on clinical trial site’s abilities to recruit, screen and enroll subjects in clinical trials for the foreseeable future. Because every clinical trial is unique, PharPoint offers flexible solutions to screening, enrollment and subject retention challenges.

Subjects visit the clinical site to complete all procedures and assessments.

Subjects will be provided with a method to collect data such as a provisioned phone, Website, or other means.  Subject visits are conducted utilizing a combination of electronic Patient Reported Outcomes (ePRO), electronic Clinician Reported Outcomes (eClinRO) and electronic Clinical Outcome Assessments (eCOA). Clinician or home health nursing visits enable in-home visits to complete study procedures such as clinician directed assessments, phlebotomy, and vital signs.

Some studies may be able to be completed with minimum physical contact with a clinician, these studies can be conducted using an approach in which Subject Visits are conducted utilizing a combination of electronic Patient Reported Outcomes (ePRO), electronic Clinician Reported Outcomes (eClinRO), electronic Clinical Outcome Assessments (eCOA), with clinician interaction via telemedicine resources to complete any clinician directed assessments.  Procedures usually requiring a clinic visit (vital signs, ECG, Spirometry, and many others) may be completed using wearables or peripheral devices linked to a user interface (usually an app).  Subject may be visited by a clinician for specific protocol-mandated procedures such as phlebotomy. Studies have proven that use of virtual subject visits enhance retention rates on clinical trials.

Any combination of the different study designs.

We can leverage relationships with our strategic partners to provide a nimble response to a variety of project needs utilizing one, or if applicable a combination of these approaches.

Want to learn more about PharPoint's remote clinical trial CRO services?