By: Kevin Liang, Senior Director Strategy, Veeva Medical Device & Diagnostics
Clinical studies are the foundation of successful development of device and diagnostic products. Studies are also complex, from site selection and subject enrollment, to study monitoring, and data management.
This year, on top of the usual challenges, COVID-19 brought many clinical studies to a halt. With the reduction of traditional face-to-face interactions at the site level, the pandemic has been a significant roadblock for the clinical research community and the medtech industry overall.
Although 54% of device and diagnostics industry professionals anticipate full recovery in clinical study activity before the end of the year, many are facing increasing costs of running trials.
However, challenges bring innovation, and forward-thinking companies are now embracing digital technologies to unify their clinical operations and drive sustainability.
Modernizing your clinical trials
Traditional clinical trials are not agile by nature. Slight changes in a protocol often require manual data entry across multiple platforms, causing delays in trial execution, increases in development costs, and ultimately impacting the price of the end product.
Combining this, with the ever-changing compliance landscape and the traditional trial approach becomes difficult to sustain. As a result, many companies are now adopting a hybrid of tried-and-true methods and new technologies to move clinical research into the digital realm.
Embracing digital transformation
Alcon is already on its way to unify operations and accelerate efficiency by leveraging cloud technology.
This global medical company specializing in eye care products with headquarters in Geneva, Switzerland, adopted Veeva’s Vault Clinical Suite to make the company’s trial systems work together and share data.
In a recent webinar, Modernizing Clinical Trials: Keeping Pace with Device & Diagnostics Innovation, Dr Kendra Hileman, Vice President and Head of Clinical R&D at Alcon, noted that the company is taking steps to modernize its clinical research program with remote monitoring, virtual visits and the implementation of technologies to support efficient clinical operations at all levels, including trial master file (TMF), study and data management.
The modernized approach enables Alcon to streamline end-to-end processes and improve how the company and its study sites work together by digitally managing electronic data capture, eTMF, clinical study management and payments.
Driving efficiency with technology
These types of improvements are high priorities for clinical research development. With the increasing duration of development cycles, escalating trial complexity and greater scrutiny from worldwide regulatory agencies, companies are under pressure to improve R&D efficiency.
An audience poll during that same webinar found that the critical areas for technology to help the industry are:
- Enhancing efficiencies and workflows (88%)
- Innovation in data management (76%)
- Compliant and reliable studies (72%)
- Scalability of processes and procedures (50%)
Matthew Purner, Senior Director of Clinical Affairs for genomics leader, Illumina, says that his company manages electronic data capture of “huge sequencing files,” and anything that can improve the management of the data is a high priority.
In the coming years, Purner predicts another significant area of focus will be the ability to connect with hospital systems and EMRs, as well as having EMRs and Case Report Forms populate automatically based on connections with other systems. This way, testing outcomes can follow patients as they come in for treatment with the ability to quickly identify patients and match them with clinical trials.
The COVID-19 pandemic has had a significant impact on planned and ongoing clinical research globally. With new restrictions in place, monitors, sites and sponsors are reassessing the ways they share information and collaborate virtually. Now more than ever, technology is critical to enable remote monitoring of clinical sites while ensuring participant safety.
David Templeton, Manager of Clinical Systems for medical device manufacturer Penumbra, says part of his company’s clinical trial modernization has included reducing the number of onsite visits, going remote more often for qualification and initiation visits, and conducting closeout visits on a fully remote basis.
Penumbra also sees opportunities in the areas of electronic consent, remote training on the use of devices and remote monitoring. Leveraging its clinical systems to impart both internal efficiencies and site collaborations has always been a high priority for Penumbra.
From a systems perspective, Templeton prioritizes tight integration of systems, as well as reduction of the number of platforms and systems being used. As companies move toward more remote trial operations, it will be essential to leverage better tools that are more powerful and easy to use for reporting, he notes.
Learning from COVID-19
The pandemic has highlighted various opportunities, as well as gaps, in the clinical research landscape, “and it would be foolish if we did not take the opportunity to learn and adapt,” says Jennifer Kerr, President of Cook Research. “It’s important to keep simplifying as much as we can, not only for us as sponsors, but for all of the stakeholders we will interact with in the clinical research.”
Another poll asked the audience to identify the top ways the industry can better support and modernize its effectiveness with clinical study sites and investigators. The results included:
- More remote collaboration and monitoring (81%)
- Technology for research sites/investors to engage with study subjects (69%)
- Enhanced site qualification and startup (58%)
- A more streamlined site reimbursement process (35%)
Kerr notes that the medical device industry shares common regulations and guidance with the life science and pharmaceutical industries. However, differences do exist in the design and management of clinical studies. Having a partner that understands and supports the medical device industry can make a difference in the adoption of new, cost-effective solutions.
With lessons learned and the right tools in hand, medical device and diagnostics companies can emerge better equipped to conduct efficient, compliant and better-informed clinical studies.
To watch the recording of the webinar download here
Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 875 customers, ranging from the world’s largest pharmaceutical, medical device & diagnostics companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America.
For more information, visit veeva.com.