Becoming a Digital Contract Research Organization
The New Standard for CROs
80% of sponsors and Contract Research Organizations (CROs) expect study start-up, recruitment, consenting, source data collection, and monitoring to be mostly digital by 2023.
Many CROs have kept up with this trend by embracing decentralized trials that combine digital technology with in-person visits.
For example, IQVIA has more than 80 decentralized clinical trials running across 40 countries as of 2020. Another major CRO, ICON, discovered that most of their patients preferred hybrid clinical trials over fully virtual or fully site-based ones.
What can we take away from this? CROs need to work closely with research sites to maintain the standard of care and connection that patients are used to. But CROs also need to embrace technology if they want to remain competitive.
With the help of well-designed clinical trial software, CROs can improve participant recruitment, retention, and data collection. But to see these benefits, you also need to know what technology to look for.
Keep reading to discover how you can use remote access, consent, and monitoring tech to improve patients’ experiences and save time and money on clinical trials.
Why the Industry Needs CROs Who Can Use Technology
U.S. clinical trials cost the pharmaceutical industry roughly $7 billion per year, and it often takes up to 10 years for a drug to move through all four trial phases.
By speeding up drug development timelines, contract research organizations will save sponsors millions of dollars. But, more importantly, they’ll ensure that patients waiting for life-changing treatments receive those treatments more quickly.
Many clinical trials encounter costly delays because of difficulties with participant recruitment, retention, and data collection. Though digital technology alone can’t solve all of these problems, it can help with each of them. Here’s how:
Technology Increases Participant Recruitment
80% of clinical trials are delayed by recruitment difficulties, and up to 50% of sites selected for a trial enroll one or fewer participants. The cost of these recruitment delays can range from $600K-$8M per day, and all of this lost money can cause sponsors to grow frustrated with their CRO.
But technology can help CROs by getting more sites involved in recruitment and helping those sites find participants. First, digital technology increases the number of research sites that CROs can work with.
Can’t find the participants you need in your immediate area? Technology platforms with remote site access allow your CRO to work with sites across the country or even across the world. These software systems give you immediate access to sites’ documents and data so you can team up with any research site with eligible patients.
But digital technology can also help individual sites recruit participants more quickly. Participants often respond better to patient-centric trials, trials that take their comfort and preferences into account.
A patient-centric trial might use patient engagement technology, like telehealth calls, eConsent forms, and smartphone apps, to keep participants engaged and save them a few trips to the clinic.
These features also help to increase recruitment. Patient-centric phase II and III trials took an average of four months to recruit 100 participants, while standard phase II and III trials took an average of seven months to recruit the same number of people. That means your CRO could speed up your recruitment timelines by 43% just by using patient engagement tech.
Software Can Improve Patient Retention
Once sites have recruited patients, they often struggle to retain those patients. The average clinical trial drop-out rate hovers between 14% and 30%. These high drop-out rates hurt CROs’ chances of winning trials from sponsors.
But technology offers a potential solution. 83% of patients say they want regular digital reminders from physicians or nurses about taking medications or scheduling appointments, and 91% of patients say they’d like digital updates from their loved one’s care team.
Digital technology lets research sites check in with participants more frequently and efficiently, which can lower drop-out rates and increase patient satisfaction. By embracing patient engagement technology, CROs prove to sponsors that they can run hybrid studies that put patients’ needs first.
Wearables Enhance Data Collection and Analysis
Remote technology like wearable devices and smartphone apps can collect participants’ data while they’re grocery shopping, exercising, or working, not just while they’re at the research site. This gives researchers the opportunity to compare how a treatment works in the real world with how it works at the clinic.
For example, one study used wearables to analyze the chest wall vibrations of patients with heart failure. The wearables automatically transmitted this data to research sites, so the data was collected in real time and was more likely to be accurate.
Real-time data collection also helps researchers identify adverse events more quickly, keeping participants safer. CROs can use their ability to provide accurate data and protect participants to win trials from sponsors.
So the key benefits of using tech include:
- Increasing patient recruitment by including more sites
- Improving patient retention by engaging participants
- Enhancing data collection by incorporating real-time data
The Technology CROs Need
In our 2021 State of the Industry Survey, 87% of sponsors said they were investing in technology because they planned to eliminate paper processes. CROs need to become digital contract research organizations to continue working with digital-only sponsors.
But many software programs don’t work well with clinical trial regulations or workflows. As technology becomes more common, CROs will need to choose efficient, compliant software systems to stand out from the crowd. Here are a few types of technology you should look into:
Remote Site Access Platforms
CROs need to seek out software that lets them view research sites’ documents and data and share documents with their sites. 71% of sponsors and CROs now say that the ability to work remotely is a key factor in what technology they choose.
Historically, CROs relied on site portals or email to share documents with their sites. Each research site had to save their documents locally, then upload those documents to the site portal. If the document needed to be updated, the CRO would have to email the site, request an update, and wait for the new document to be uploaded.
Electronic Investigator Site Files (eISFs) with remote site access can make sharing documents and data more efficient. Sites control their eISF and can store all of their documents and data inside it. But they can also give their CRO access to specific documents.
With remote access to sites’ documents and data, a digital contract research organization can conduct remote monitoring visits. 76% of sponsors conducted most or all of their monitoring remotely in 2020, and 83% of sponsors expect most monitoring to be remote by 2023.
That means that to win sponsors’ business, CROs need to prove they can monitor remotely. However, 30% of sponsors worry that all of their sites won’t adopt the technology that allows remote monitoring. It’s important to search for clinical trial technology that’s designed for sites and that sites control.
Research sites and CROs also need remote monitoring tech with staff can leave notes for site staff letting them know when documents need to be updated. Once the site makes the requested changes, the CRO can see the newest version of the document instantly.
CROs need to make clinical trials more patient-centric to improve recruitment and retention–but that means finding the right patient-centric technology.
Some CROs have chosen to embrace mobile apps for data collection and for informed consent (You can learn more about the crucial components of eConsent here.) These apps let participants visit the site less often. Other CROs have chosen texting programs that remind participants of when they have appointments or need to take their medication.
When selecting patient-centric technology, CROs need to listen to participants as well as doctors, caregivers, and patient advocacy groups. What technology will help participants the most depends on whether the patients are already coping with an illness, how tech-savvy they are, and whether they have regular access to phones or computers.
How CROs Can Prepare for the Future of Research
CROs need to embrace efficient, compliant technology to avoid being left behind. By incorporating remote site access and patient engagement technology into your daily workflows, you can offer sponsors impressive patient recruitment, participant retention, and data collection abilities.
Curious about becoming a digital contract research organization? Check out our free Moving Beyond COVID webinar, which features speakers from Pfizer, Total Clinical Trial Management, and Aperio Clinical Outcomes. These experts discuss which technology they embraced during 2020, what software was most valuable to them, and which tech they see CROs using in the future.