Improve Recruitment, Retention & Compliance by Mobilizing Your Trial
Why should sponsors & CROs consider using mobile nursing for in‐home clinical trial visits?
These visits are more convenient for study participants and can improve their recruitment, retention, and compliance while expanding your trial’s geographic reach. This can reduce the number of study participants you need, which accelerates your clinical trial and lowers its overall cost.
How do mobile nursing visits benefit study participants?
- Save time and money for those who live long distances from the site
- Alleviate stress and scheduling challenges for those dependent on others for transportation such as elderly, disabled or pediatric study participants
- Enable home-bound study participants to participate in trials
- Eliminates “visit fatigue,” which can cause study dropouts
What can CMRNs do on a mobile nursing visit?
Their activities in the home setting include anything within the scope of practice of an RN that can be done with portable equipment and has an acceptable risk profile. These commonly include:
- Adverse Event Assessments
- Concomitant medications
- Sample collection and processing
- Subject training
- Drug accountability
- Much more
How do I incorporate mobile nursing visits into my clinical trial?
Mobile nursing visits can be initiated either during protocol development or afterwards as a “rescue” strategy to improve study participant recruitment and/or retention. Each CMRN signs a Delegation of Authority log with the Principal Investigator for whom they are working.
How does the mobile nurse work with site personnel?
Our CMRNs work collaboratively with the Investigator and Site Coordinator to make sure that the study participant visit meets the target date and is completed with the same dedication to quality as an on-site visit. If requested, they can go to the site for training. For many clinical trials, CMRNs will visit the site to pick up investigational product, lab kits or supplies.
How do you coordinate with central lab and pharmacy?
Central labs typically send pre-made lab kits to our CMRNs with return packaging to send back collected and processed samples. When IP administration is part of the home visit, the nurse coordinates with a central or local pharmacy to have the product shipped within required parameters of the drug (stability, temperature control, limited access, etc.) and targeted time frame for its administration.
What is the typical service model for mobile nursing visits?
Generally, the service provider sub-contracts with local in-home care agencies near the site or study participant to provide nurses for home visits. Most of these small in-home care agencies do not have Standard Operating Procedures (SOP) for clinical trial home visits. Their screening practices vary greatly and their nurses often have no experience in clinical research. These factors can affect data quality and increase the risks for sponsors and CROs.
What are the advantages of using PCM TRIALS over traditional service models?
PCM TRIALS screens, hires, trains, tests and manages all of our own clinical research nurses. All are screened through the FDA, SAM.GOV, GSA, OIG/HHS, NURSYS and state licensing boards. Their credentials and health records are up to date and in compliance with industry standards.
Each nurse is trained, tested, and certified as a Certified Mobile Research Nurse (CMRN) every 18 months in the principles of clinical trial research, Good Clinical Practice (GCP), SOPs and International Air Transport Association (IATA) where applicable. Because our CMRNs understand the critical requirements of mobile clinical research, sponsors, CROs and sites can be confident that their mobile nursing visits will be carried out with the same quality and care as on-site visits.
Since 2008, PCM TRIALS’ CMRNs have worked on 225+ protocols for 120+ different sponsors, and 25,000 direct-to-patient visits, including dozens of CROs in a wide range of therapeutic areas. Our mobile nursing services are available throughout the U.S. and around the world.
PCM TRIALS can help improve study participant recruitment, retention, and compliance, which can enable your company to complete clinical trials faster at a lower cost. To learn more, contact [email protected] or call 888-628-9707.