In an industry that has seen rapid change over recent years, how you identify the “right” CRO for your clinical research trials may be changing, as well.
That’s because there’s a lot to adapt to as the entire research landscape continues to evolve. Patient advocacy organizations have morphed into patient-led research organizations; decentralized trials and remote monitoring have become standard; and CROs are merging to become…well, even larger CROs.
However, a recent survey showed that increasingly, sponsors are responding to these changes by actively seeking out a truly personalized, human-centered approach to navigating their trials. And that means finding a CRO partner who doesn’t just say they’re personalized with accessible experts – but who truly are.
“A CRO that breaks down communication barriers and provides accessible expertise to sponsors is no small thing, given the complexity, high pressure, and rigid timelines in drug development,” said Aman Khera, Vice President of Regulatory Science, Strategy, and Innovation in the Scientific Solutions team at Worldwide Clinical Trials. Her commitment to ensuring accessible expertise for sponsors while empowering patients drives the organization’s unique approach. “When you find one who does that, you’ve found a very valuable partner,” she said.
Accessible expertise: A key differentiator
Khera came to Worldwide to roll up her sleeves and make a difference. She found her place at Worldwide, where that dedication to personalization and accessible expertise is at the company’s more than 30-year core. “We’re able to provide direct access to experts whenever it’s needed,” she said. “A sponsor can pick up the phone and say, ‘Look, I have this issue,’ or ‘Do you know of a partner that could help with this?’”
That genuine willingness to connect and share knowledge comes from an authentic desire to contribute to science and to the growth of the industry. “Those of us at the height of our careers in scientific solutions want to share knowledge. We are in an era where access to knowledge from scientific solutions shouldn’t be withheld as we sit alongside the operational teams,” Khera said.
Why is this access to experts critical? Time is of the essence — Khera encourages sponsors keen to hit a pivotal trial to engage with regulatory agencies early and as often as possible. Expedited programs and initiatives save so much in the long run; for example, sponsors can get the convergence of feedback utilizing the parallel scientific advice pathway, with the Food and Drug Administration (FDA) and the European Medicines Agency.
“By being actively involved with sponsors through that process, it saves them time and money,” Khera said. “At Worldwide, we’re submitting so many clinical trial applications and having so many discussions with various regulatory agencies across the world — the engagement we’re getting means we see changes in agency tone and tenor as it happens.” That translates to practically real-time knowledge updates that pay off in an industry where time is critical.
Nimble partners allow for patient empowerment
As patients and patient advocates become more engaged and involved in clinical research, the shifting landscape means that a CRO who has the ability to address changing patient needs and pivot quickly to address them means studies stay on track – and on time.
“Our size means that our scientific solutions team is able to get ‘plugged in’ early and often throughout the life of the trial, and we can help advise sponsors who sometimes don’t quite know how to get to an optimal development journey,” Khera said. But because of Worldwide’s global reach, they’re also able to draw from years of study experience around the globe – and allow sponsors to tap into that to flex quickly. “We offer a prompt or reminder like, ‘Did you think about this? Because we just thought about this in another clinical trial, and maybe this is a solution you need to consider in your product’s development journey.’”
The critical importance of being able to nimbly adapt to patient needs – and the industry’s ability to ensure patients are truly at the center of research – hit home for Khera personally. “I thought I knew about pediatric rare diseases and was doing everything I could do in the space,” she said. “However, my recent entry into the extended care circle experience for a child diagnosed with a rare disease has taught me more about where I need to improve and how the industry can improve.”
After all, that shift is happening now, Khera explained. “On Rare Disease Day meetings, the FDA is not asking sponsors to come to the front. But they want to hear from patients and caregivers.”
Partnering with a CRO that is responsive, personalized, and has truly accessible experts has never been as important as it is today. “We may need to collaborate with strategic partners we never imagined we would need to, to help bring that patient journey full circle,” Aman said. “We always need to be asking ourselves, ‘What can we do to make that journey better? And how can we best partner with sponsors to help create the best possible outcome for everyone?’ That’s what being accessible experts really means. It means knowing you’ve got an extended team who is right beside you every step of the way, without hesitation.”