Alin Lungescu, Co-Founder & CEO and Darran Boyer, Co-Founder, President and Director Of Quality Assurance “We are dedicated to enabling sponsors and CROs to make well-informed enrollment decisions based on accurate participant data,” says Darran Boyer, co-founder, president and director of quality assurance.
Setting new standards across the U.S., Canada and Latin America, clinicalRSVP’s platform captures key data points like enrollment dates, last dosage and washout periods to ensure researchers have complete visibility into participants’ trial histories. This makes their participant pools more legitimate and uncontaminated by cross-enrollment of subjects who may not follow the necessary protocols, enroll in the same study twice at different locations or use fake IDs.
The Journey to Addressing an Incessant Challenge
The dual enrollment dilemma has long plagued the clinical trial space, and the idea to establish clinicalRSVP was born out of this critical need. The chain of events that led to its establishment began with a clinical research site in South Florida. While working with an investigational review board (IRB), the site identified that many of their participants had also been involved in other clinical trials. The common link between the studies was the IRB. Faced with a legal and ethical dilemma, the research site approached the IRB for an efficient resolution.
At the time of the incident, co-founder and CEO Alin Lungescu had been helping the IRB build back-end platforms to manage its organizational structure. In a stroke of luck, one of Boyer’s relatives was working at the IRB and informed him of the opportunity to create a distinct solution to address the issue.
After a discussion, Boyer and Lungescu realized they could create a solution that catered to the niche requirement and founded clinicalRSVP.
The two leveraged the IRB’s knowledge of ethical practices and created the perfect solution. Lungescu’s prior experience with laboratory information management systems and Boyer’s expertise in quality assurance resulted in a perfect partnership.
Solving the Dual Enrollment Puzzle with Unmatched Security
A key focus for Boyer in establishing clinicalRSVP was to collect as little information as possible. The company demonstrates high standards of legal and ethical practice in the use and disclosure of personal information of research study subjects.
It limits the amount of information collected to key details, like the patient’s date of birth and gender at birth, initial dose date, final dose date, final visit date, the last four digits of a government-issued ID and a fingerprint scan. This safeguards the privacy of patients and research organizations, minimizing the risk of personal data exposure.
We pride ourselves on making sure our clients feel comfortable that the systems they use are validated
clinicalRSVP understands the significance of keeping confidential information under lock and key. The system operates independently from any clinical trial sponsor databases, using only blinded, de-identified data to ensure that sensitive study data is never shared or exposed.
On the security front, clinicalRSVP adheres to Title 21 of the Code of Federal Regulations Part 11, which outlines stringent controls over electronic records. The platform’s validation reports and comprehensive data security documentation protect users during any sponsor or regulatory audits that may occur at research sites. Combined with SOC-2 compliance audits, these steps create an ironclad layer of protection. Stringent compliance is also maintained with privacy laws like HIPAA in the U.S. and the Personal Information Protection and Electronic Documents Act in Canada.
“We pride ourselves on making sure our clients feel comfortable that the systems they use are validated,” says Lungescu.
The platform also follows advanced encryption protocols, including a sockets layer, for secure data transmission over the internet. Its independent structure further eliminates the risk of data co-mingling between competitors or across borders, providing an added level of assurance to clients. Researchers can stay focused on the study, knowing that participant safety and trial integrity are in capable hands.
The biometric solution has proven highly effective in overcoming the limitations of relying on demographics alone. It’s not uncommon for participants with identical or near identical names and dates of births to enroll in various studies. In these cases, the system leverages biometric data to distinguish if two sets of similar demographics are indeed the same person or two separate individuals. This approach resolves the risk of incorrectly preventing eligible individuals from participating.
Raising the Bar on User Experience
clinicalRSVP’s ease of use and seamless integration into clinical research workflows enables users to focus on their core expertise. The biometric fingerprint identification system is designed to be straightforward, requiring minimal training for research site staff.
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Many industry leaders recognize the need for a single registry or at least for multiple registries to communicate with one another
Client support is offered 24/7, from installing biometric readers to on-site software validation. A dedicated support team works closely with research staff to provide training and troubleshooting services.
Its web-based portal offers flexible access for any research institution, from small sites to large-scale CROs. Users can log in to the company’s website to authenticate subjects. The platform’s ability to integrate via API into existing clinical trial management systems allows it to fit into various operational environments without disrupting existing processes. For sites that don’t want a full integration, the portal permits easy manual entry of key dates, like final dosage or washout dates, making it highly adaptable for all needs.
Participants are also offered a transparent, seamless experience. Before enrollment, subjects receive an authorization form outlining the use of clinicalRSVP’s fingerprint identification system and subject verification programs. The system is designed to promptly address discrepancies through its accuracy validation process. Participants are also offered a direct line of communication to resolve issues. The team is just one call away.
For example, some participants enroll but withdraw from studies before completing them. In these cases, if the platform flags the participant as ineligible for a subsequent study, they can contact the company and point out the discrepancy. Its team considers every detail and identifies the most eligible candidates, upholding trial integrity.
Patented Technology toward a Single Registry to Prevent Dual Enrollment
With patents and exclusive rights to use the technology to prevent dual enrollment, clinicalRSVP maintains its system’s effectiveness and leadership position in the market.
“Many industry leaders recognize the need for a single registry or at least for multiple registries to communicate with one another. Our hope is that US Patent law will help steer the industry towards that unified goal,” says Boyer.
Building on its position as one of the earliest dual enrollment solution providers, the company has elevated trial integrity by establishing a clear directive for network sponsors and sites to follow. Its distinctive ability to track subjects across borders has revealed valuable insights. For example, it has uncovered the tendency of some participants to travel from the U.S. to Canada and even Latin America to join clinical trials. clinicalRSVP’s efforts to build a single registry to check enrollments have significantly advanced the research industry’s efforts.
clinicalRSVP elevates industry standards for authenticity and confidentiality, empowering researchers to confidently navigate the complex enrollment practices in clinical trials without compromising the integrity of the trials.
