Ask These 10 Questions Before Choosing a Mobile Research Nursing Provider
If you’re like a growing number of sponsors or CROs, you already recognize the many benefits of conducting a hybrid or fully remote clinical trial. However, not all remote visit providers are the same. So how do you decide which one is right for your next trial?
Start by asking the following questions and critically comparing the answers you receive.
1. How much experience does the prospective provider have handling a fully remote or hybrid trial?
• Are mobile visits part of what they do, or are they the only thing they do?
• Is the provider independently owned and managed or part of a larger organization that also offers other services beyond gathering clinical research?
It’s important that the remote visit provider you choose has extensive knowledge about the unique challenges and demands of conducting hybrid or remote trials and did not simply add home visits to its list of services as a type of opportunistic response to the growing demand for decentralized trials (DCTs). In the case of PCM Trials, for example, remote research is all the company has done since 2008. Over that time, it has completed more than 400 protocols for many of the biggest names in Pharma, including several of the most highly visible trials conducted during the peak of the COVID pandemic. Independently owned, the company has full teams of experts ready to support the specialized needs of DCTs.
2. What data collection and review policies and processes does the provider have in place to ensure the quality and consistency of the data?
• Does the company hold mobile components to the same standards as traditional trials?
Don’t overlook the details when it comes to discussing a prospective partner’s ability and track record for providing the highest quality and consistent trial data. PCM Trials is GDPR-compliant with highly trained teams that are ready to support a full range of clinical activities that are within the scope of registered nurses and can be safely delivered with portable equipment. In addition, 100% of source data is checked within 48 hours to help ensure accuracy and meet the highest clinical standards.
3. How well does the provider work with other trial partners?
• Can my organization still have total control over the protocol of the remote visit?
• How does the provider approach collaboration?
Collaboration is key to success. PCM Trials has a long history of collaborating with site sponsors, CROs, and clinical research sites with one goal in mind — trial success. This approach means that sponsors and CROs are able to maintain full control over trial integrity and have transparent insight into everything that’s occurring with the trial.
4. What populations can the prospective provider reach?
• Does it have any geographic restrictions?
• Does the company understand the different restrictions by state or country?
• Can the provider access patients with rare diseases?
• Can the provider reach a diverse patient population?
Today’s clinical trials are more demanding than ever, requiring that providers be able to reach niche populations in hard-to-reach geographies. PCM Trials mobile research nurses travel virtually anywhere that is convenient for patients, their families, and caregivers. PCM Trials has made more than 25,000 home visits on multiple continents for more than 120 sponsors and CROs, including the largest pharmaceutical companies in the world.
5. What is the provider’s relationship with its mobile research nurses?
• Does the company hire and train them or outsource them?
Many remote clinical trial providers today rely on third-party nurse staffing agencies to screen and manage their nurses. To maintain the highest data quality and integrity, PCM Trials manages, trains and certifies its own nurses. It’s a model the company has followed since its inception. Since then, other companies have attempted to mimic this model, but no one has been employing its own mobile research nurses longer than PCM.
The company carefully screens its nurses to ensure they not only possess the necessary clinical skills but are also able to solve problems that may arise unexpectedly and which could jeopardize data quality if not handled properly and according to protocol. PCM Trials then goes a step further by certifying their nurses, a process that involves preparing them for clinical situations unique to a non-medical setting. Through this direct relationship, PCM Trials is always only a phone call away in communicating any changes in trial protocols to its nurses.
6. What is the skill level of the provider’s nurses?
• What type of training do they receive?
• Does the provider use nurse generalists or mobile visit specialists trained to work independently away from the site and able to handle unexpected situations alone outside of a controlled facility?
This is a key differentiator when choosing a remote visit provider. Nurses who have spent all their time in a clinical setting may not be adequately prepared for the unique challenges faced when providing medical service in the home or workplace. PCM Trials nurses are specialists in mobile visits. PCM Trials exclusively hires RNs and then provides specialized training so they can confidently handle portable medical equipment and meet the needs of the specific remote trial protocols. All PCM nurses also receive additional training in Good Clinical Practice (GCP), General Dtaa Protection Regulation (GDPR) and related safety training, as well as training that is specific to the protocols of a given clinical trial.
7. How quickly can the provider ramp up and start enrollment?
• Does the company have any experience in rescuing trials?
Speed-to-market is critical in the clinical trials industry. Since PCM Trials employs its own nurses, they are able to start enrollments in record time. For the industry’s largest clinical trial involving Parkinson’s disease patients (TOPAZ) , for example, PCM Trials beat projections by enrolling 595 patients in 45 states. And during the recent COVID-19 pandemic when a record number of trials were on the verge of failing or, at minimum, being delayed, PCM Trials was able to step in and rescue dozens of them.
8. What does the provider do to ensure a patient-centric experience?
• What is the company’s track record for patient satisfaction?
The whole industry is moving toward more patient-centric models in an effort to attract more patients to participate and retain patients without the need to re-enroll high numbers of new participants. But this is not a new approach for PCM Trials. Its nurses have been focused on making patients feel at home and at ease for years. PCM Trials employs full operations teams that support their Certified Mobile Research Nurses (CMRNs) to ensure no details are overlooked and that patients and nurses have everything they need at their fingertips to ensure smooth remote monitoring and data collection. This includes project managers who coordinate with pharmacies to ensure timely deliveries of necessary drugs and supplies. As a result of high patient satisfaction and cooperation, PCM Trials was able to maintain a near-100% in-window clinical visit rating even during the COVID pandemic.
9. How flexible is the prospective provider?
• Does the company have minimum thresholds relative to size or any other restrictions/requirements?
• Will the provider do short- and long-term studies?
• Can the company pivot quickly to accommodate changes in trial protocols or visit intervals?
Some multi-service providers may not be interested or have the in-house capabilities to handle anything but large, short-term clinical trials. As an independent, specialized, and remote-focused partner, PCM Trials is able and willing to handle nearly any size or duration of clinical trial. They have proven time and again (especially during the COVID pandemic when PCM Trials had to be especially creative) that effective partners must quickly pivot to adapt to changing protocols and visit intervals. The company prides itself on offering fit-for-purpose services that are customized and built around a client’s particular problem.
10. How does the provider measure success?
Before choosing your remote clinical trial provider, it’s important to ensure you both have shared views of what success looks like. DCTs, by their nature, offer a number of advantages that support trial success, including faster enrollment, higher retention, improved adherence, and a more diverse trial population. The right partner can move the needle on all of these benefits.
PCM Trials has a track record of success enrolling patients in record time, retaining them, meeting in-window visit goals, and maintaining data integrity. This has led to overall lower trial costs and repeat and referral business by some of the largest pharmaceutical companies in the world. In the end, though, the best measurement of success is this: PCM Trials has played an integral role in helping to bring to market more than 100 new drugs.
Evaluating potential partners for your next clinical trial? Learn more about PCM Trials and discuss how a decentralized or hybrid strategy can improve your trial’s outcome. Call 888-628-9707 or visit https://pcmtrials.com/request-for-proposal/ to submit your RFP.