UPDATED: This post was updated for 2018 to reflect new information and more examples. Enjoy!
Academic research is where all clinical research begins. Whether you consider investigators exploring new theories or students learning how trials are run – who then go on to larger industry organizations – academic institutions are the foundation for it all. Academic clinical trials hold an integral role in the industry as they work to advance and improve treatment outcomes.
But just because academic clinical trials are not funded by for-profit organizations like pharmaceutical or biotechnology companies, they should not be restricted to paper-based data collection methods due to budgetary constraints. They should have access to digital solutions that optimize their data collection and management process, too. This was a motivating factor when Clinical Studio was created nearly a decade ago: develop a powerful platform and make it available to all researchers at fraction of the cost of the industry standard.
Clinical Studio is a sophisticated and cost-effective eClinical solution to build research studies, gather data in a cloud environment, and generate analytics any time and any place. This platform is suitable for academic research organizations across the globe in addition to being a great fit for CROs, sponsors, and independent investigators. Below are a handful of the reasons many academic institutions accredit their increased efficiencies to Clinical Studio:
Data compliance and security measures
Clinical Studio complies with all 21 CFR Part 11 guidelines, GDPR, HIPAA, EMEA Annex 11, Privacy Shield EU-US, and HiTrust. The system establishes a full audit trail, a version control system, and configurable edit checks to assure users that any changes to a study will adhere to regulatory requirements. Clinical Studio produces clean and traceable data that can be used for submissions to the FDA and other governing bodies for approval.
The security and integrity of the data gathered using Clinical Studio is of the utmost importance to us. That’s why data entering and exiting Clinical Studio servers is encrypted using the healthcare-industry standard 128-bit SSL and 2048-bit RSA public keys. Networks are protected and constantly monitored both physically and remotely as well.
An enterprise-level cloud-based software product, Clinical Studio is accessible from any web browser or native mobile app for iOS and Android (Clinical Studio’s companion product, TrialKit). Both Clinical Studio and TrialKit are capable of accommodating an unlimited number of studies in a single instance; this means you’re able to change from study to study within the same window. There is also no limit to the number of users who may access and manage data simultaneously from a mobile device or desktop computer.
Alternatively, organizations have the option of hosting their studies on a private cloud server. The private cloud offers the same benefits as Clinical Studio’s main cloud, but also provides more control over the hardware.
Built-in patient reporting
Using Clinical Studio’s Form Builder, academic research teams can build highly configurable electronic case report forms (eCRFs) and surveys. Forms can be made accessible for patients to submit their own data directly into the database from any web browser or mobile device via electronic patient-reported outcomes (ePRO). This way, patients can submit their results remotely, lessening the number of clinic site visits they’d be otherwise obligated to attend.
eCRFs and surveys in Clinical Studio or TrialKit may include simple fields such as multiple choice or short answer, but the system is capable of collecting photos, videos, and audio segments, too. Academic research teams now have the ability to leverage mobile technology to gather real-world data from activities such as range of motion, step motion, and heart rate.
Used for every phase of research
Clinical Studio is used worldwide for research ranging from simple patient surveys to pre-clinical to phase IV. Studies from a wide variety of therapeutic areas have been conducted on the platform as well: oncology, cardiovascular, orthopedics, rare disease and beyond.
Our product experts are standing by to personally assist you as you become familiar with the system. Our goal is to ensure Clinical Studio makes your research more efficient. Training is provided at no additional cost, beginning with the first day of your 30 day trial.
24/7 customer support
Study administrators and study sites have instant, around-the-clock access to technical support and guidance. Our customer support team is eager to answer any questions you may encounter throughout the life of your study.
Clinical Studio is also equipped with a comprehensive help portal – a great resource for detailed step-by-step instructions on every functionality of the system. The help portal has a search function that enables you to easily find the articles related to your query.
In keeping with our mission, we believe as much of the the grant funding for academic research should go to the research as possible, not to the technology tools used to design and manage them. Get in touch with us today to inquire about discounted rates for conducting academic clinical research in Clinical Studio.