Digital technology is now completely intertwined with our lives. It’s transformed the way we communicate personally and professionally and has revolutionized industries from business to banking to transportation.
The clinical research industry may have been cautious about going digital, but researchers need to be aware that new tech, such as an eClinical platform, will play a more significant role in the future:
- Regulators, including the FDA, EMA, and others, have expressed their support of using new tech to eliminate research inefficiencies and to serve public health better.
- Tightening global regulations like EU MDR and others require vastly more post-market surveillance and necessitate digital solutions.
- A dramatic increase in outsourcing has made conducting trials on paper even more expensive and cumbersome — if not impossible.
With this shift, new Electronic Data Capture (EDC) and Direct Data Capture (DDC) solutions have emerged to support and facilitate research. This variety has many positives and provides more assurance that researchers will get their needs met.
Still, too much choice can also potentially confuse and complicate the selection process. Since lives are often at stake when it comes to clinical research, best-fit solutions are a must. Take a look at 5 essential considerations when choosing an eClinical platform:
1. Data Quality
It’s crucial to learn how a platform ensures data accuracy. Clean data is the foundation of clinical research, and data problems can hinder the path to regulatory approval.
Medrio’s EDC, for example, has form rules like edit checks and skip logic to help ensure rapid and precise data entry.
Data is then instantly available for review, analysis, and collaboration with Contract Research Organization (CRO) and site partners. Additionally, Medrio DDC, an eSource solution, has shown to reduce transcription errors by 90%.
2. Regulatory Compliance
Check how an eClinical service facilitates compliance. In recent years, global clinical trial regulations have undergone tremendous change — and more is on the horizon.
Quality solutions should take compliance concerns off researchers’ plates, so they have full peace of mind as they move towards their goals.
For Medrio, the software directly integrates global compliance. Additionally, a dedicated team stays on top of upcoming shifts and updates the platform well before any new regulations go into effect.
3. Flexibility and Adaptability
Control and independence are also essential considerations. Legacy eClinical services often deliver sophisticated solutions that require external support, which can lead to protracted study builds and time-consuming delays. Consider if this type of solution is necessary since research teams can often manage trials easily and independently.
We recently sat down with one of our customer success managers who also worked in clinical operations for 15 years. She shared her personal experiences using Medrio and another large EDC and described how, with Medrio, she was able to build and manage studies without outside programming support.
Also, during the research process, unexpected obstacles can arise, and researchers need to adapt quickly to stay on a timeline and budget. Check how a service can support you when the unexpected happens.
For Medrio, we provide several APIs that can help organizations quickly expand their eClinical capabilities to integrate external platforms if necessary.
4. Customer Support and Training
Evaluate the support team. If any snags come along during research, you want to be sure you’re in good hands. Check if they have industry experience and regulatory knowledge. Can they understand and empathize with your challenges? How responsive is the team, and how intuitive is the software? For Medrio, many customer support managers have industry experience.
91% of support cases submitted to Medrio’s headquarters receive responses in 10 minutes or less — no matter what time or day of the week. Also, robust eLearning ensures that users get up and running in no time.
5. Is It Reliable?
Finally, it’s vital to look into the track record of an eClinical service provider. How have other researchers leveraged this software for success? How long has the organization been around? Do they have experience working with similar types of research?
Medrio has been around for 15 years and has been used in 4,500+ studies with 600+ customers with a 98% customer satisfaction rating.
While many eClinical service providers have been affected by recent acquisitions, we stay independent, in control, and entirely focused on customers’ needs.
New technology is only going further integrate with clinical trials. And while adapting to the evolving clinical research landscape may come with growing pains, there is vast potential to improve public health in ways that, until recently, seemed out of reach. Choosing an eClinical platform can be a challenging process.
Still, focusing on the right questions and finding best-fit solutions can save vast amounts of resources down the road — and better serve populations in need.
