It’s hard to believe that one event can impact the direction of the pharmaceutical industry. And yet, that’s precisely how the COVID-19 pandemic shed light on the importance of strategic partnerships between pharma and contract research organizations (CROs).
Since the onset of COVID-19 and the global vaccine management campaign that followed, pharmaceutical companies are fast-tracked to meet the growing demands for vaccines and continue further research to bring other medical treatments to market. But they also face staggering costs and unanticipated testing challenges.
Experts estimate that the average cost of developing a new prescription for market stands at almost one billion dollars ($985.3 million), and specialized medications that target therapeutic areas cost more than that, with estimates hovering around $2.7 billion.
But what if a pharma company could offset some of those costs without delaying the manufacturing of new products? Could a CRO partnership be the solution?
When Pfizer needed to cut billions of dollars from its R&D budget, it looked for new avenues to trim costs. Part of that strategy included forming a two-pronged CRO partnership with Parexel and Icon to handle the bulk of the R&D work while Pfizer could oversee the clinical process. Combining resources from a pharma company partnered with a CRO set the stage for the unexpected shift from onsite in-person clinical trials to a hybrid, virtual model, thus bolstering transformative digital staying power in the clinical trials arena. Let’s examine more closely how this partnership can succeed:
Digitization of the clinical trial model
The key to the interoperability between pharma and CRO is the participants themselves. Under the onsite model, the participants are identified by a number, and the focus has been on their trial results rather than on them. By contrast, the hybrid, virtual models challenge the traditional dynamic and shift the focus back to where it belongs— the participants.
Under the onsite model, the burden was placed all on the patients. Participants had to show up to the site, engage in the study, hoping that they were contributing to finding a cure to their health issues, and follow CROs’ rules no matter how inconvenient they may have been. Think of it as the “jury duty” of the pharma world.
By using the hybrid and virtual models, CROs cater to the participants by sourcing and onboarding them online, assigning them a clinical trial associate or manager for care, sending them the clinical trial kit, remotely monitoring med-device for trial-related data, and routinely inquiring about their well-being.
Shifting the focus back on the participants in a clinical trial through virtual and hybrid models adds value in the following ways:
— Remove the limitation on the geographic location, and hence the need for site maintenance.
— Rely on med devices to collect participant metrics for accuracy and to limit human error.
— Transitioned from sticky notes to paperless. Remote trials require a robust paperless trial management system.
Let’s face it. Not all partnerships are equipped to accommodate a virtual, hybrid trial model. But the ideal automated platform will offer custom solutions that cater to participant-centric services. Here’s how:
Sponsors can connect directly to CROs’ systems
A system like Salesforce’s Experience Cloud allows CROs to build custom-branded portals to which participants can log in, stay current on the trial-related information, and self-submit symptoms.
Collect data from participants’ med devices
Clinical research associates (CRAs) can track their participants’ well-being, tasks, and next steps in real-time all through a single dashboard. “A clinical study is nothing without data, and a considerable amount of heavy lifting in the value of virtual trials is done via the ease and speed of data collection afforded by the wealth of technology on the market,” says Alexander O’Leary. “In many cases, the data can be collected and sent for analysis automatically, completely ruling out the ‘I forgot to do it’ element.”
Automated threshold alerts and guided decisions allow the CRAs to quickly resolve issues as and when they arise.
Submit data to clinicaltrials.org seamlessly
Lastly, sponsors can monitor the overall trial financials, progress, and results through the same platform, thus increasing trust in the trials and the CROs. Therefore, everyone wins by bringing the focus back onto the participants.
The pathway to better healthcare and innovative medical treatments rests on trustworthy data collected, shared, and analyzed through clinical trials. A strategic pharma and CRO partnership provides essential data that heightens the patient experience, eliminates socio-economic barriers, and helps make healthcare accessible to everyone.