Clinical trials are in a constant state of flux with scientific and technology advances reported nearly every day. This makes clinical programs complicated to staff. Such a fluid environment doesn’t lend itself to hiring full-time personnel, which is why so many sponsors rely on functional service provider (FSP) models.
FSP providers deliver sponsors on-demand, seasoned resources who can be ramped up or down as a trial progresses and shifts. But the most effective FSP models are about more than just the people. They work in partnership with a sponsor to develop a holistic strategy that helps clinical study teams work faster, smarter and more efficiently.
Today, technology advances in the clinical research space are driving an evolution of the FSP model, bringing new approaches for sponsors, while making CRAs jobs easier and more productive.
These technologies don’t eliminate the need for CRAs. But they reduce the friction that often comes with a complicated and time-consuming role. CRAs typically oversee multiple trial sites, collecting and uploading trial data, interfacing with site staff, monitoring risks, and making sure every patient receives the support they need. It’s a high-pressure, high-turnover job, but challenges and staff transition can be eased through the thoughtful use of technology.
Here at IQVIA, we’re advancing traditional FSP models by leveraging advanced technologies with the power to support CRAs, making their jobs easier while delivering added value for site staff, patients and sponsors.
Here are a few examples.
One of the biggest frustrations for sites and sponsors is the investigator payment process. Lack of transparency about when sites are going to be paid, what they are owed, and when they get a payment creates constant cash flow bottlenecks and dissatisfaction among hard-working site staff.
CRAs face the brunt of these frustrations. They are the primary contact that site staff have with the CRO and sponsors, so they become the recipient of all payment requests – and complaints. That creates a lot of added work for CRAs who need to chase down answers and act as the communication bridge between sites, sponsors and CROs.
IQVIA’s payment portal eliminates these bottlenecks and provides payment transparency for everyone involved. Site staff and CRAs can log into the portal to review activities and monitor past and pending payments; while sponsors can see what they are paying for and how it effects the budget. They can use the platform to manage payments for every trial and site in their program, which provides instant transparency into cash flow and the data they need to track costs and compare results at a portfolio level.
Most importantly, this shared payment portal removes CRAs from the payment conversation, freeing them to focus on the trial oversight activities for which they were hired.
Informed Consent Forms (ICFs) are among the most important documents captured in any trial. Every time a patient is recruited for a trial, they have to sign extensive consent forms to participate. They then need to re-sign those forms if they come of age during the trial, or whenever a protocol amendment occurs. Protocol amendments take many forms and can include new findings that change the risk/benefit profile of the treatment, changes in study procedures, or if access to new alternative treatments becomes available.
In longer trials, patients may be required to sign dozens of versions of the ICF, making it very difficult for site staff to manage version control. With no transparency into whether patients are up to-date, and which forms are currently relevant, trials can quickly fall out of compliance.
That is huge red flag for auditors. One study conducted by the FDA Bioresearch Monitoring Program found that inconsistently approved/signed/dated consent forms ranked among the top three most frequently cited findings by clinical trial inspectors from 2015 to 2018.
IQVIA’s eConsent platform eliminates this risk. Patients sign all of their consent forms through the automated system, so the most up-to-date version is always used and where patients can also access videos and content that explains the consent process and the study to make it more patient-friendly.
Whenever there is a change to the ICF, the system will alert investigators and CRAs that an updated version of the form is required to be completed, to help make sure they remain in compliance.
It provides frictionless consent form management, that reduces safety risks, and gives CRAs digital access to the status of these important patient documents. This allows them to manage the paperwork remotely so they can spend more time on-site engaging with staff. And when inspectors audit these sites, they are able to determine instantly whether the forms are up-to-date.
Study site staff and CRAs can spend hours on low-value, administrative tasks, including uploading documents, closing out queries, tracking site training and copying the same information into multiple forms and fields. IQVIA’s Investigator Site Portal eliminates a lot of that administrative burden, while giving site staff, sponsors and CROS a shared portal to manage all information and tasks.
The portal automates manual tasks, including visit calculators, dosing calculators, patient eligibility forms, clinical supplies requests (the list goes on!), while providing investigator teams a central location for document management, trial information, alerts, updates on recruiting status, and other trial specific information. It also links to site training, newsletters, and other trial communications.
With these resources in a single location, CRAs and site staff can more easily tackle their tasks by aligning them to the most business critical tasks. The result: improved audit transparency; reduced timelines and costs. It also makes it easy for sponsors, CROs and site personnel to monitor trial progress. That leads to a happier and more engaged team.
These are just a few of the technologies IQVIA uses to support FSP customers and to take the friction out of trial management. When we combine the expertise of seasoned CRAs with these innovative technologies, it optimizes the trial environment, and delivers value for everyone involved.
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