Clinical Trial Management Technology

IVD research is unique and often complex

You need a clinical trial management partner that truly understands the intricacies and nuances of running an IVD trial and who can support your product’s entire validation process. RDI’s technology helps take your IVD product from concept to market seamlessly, backed by our extensive domain expertise.

Diagnostica

Diagnostica, our clinical trial management platform technology, is built for the entire clinical trial process, designed by IVD experts for IVD experts.

Reach out to thousands of physicians with an automated campaign to gauge interest.

Manage and organize feasibility responses to target based on budget, expertise, and enrollment forecasts.

21 CFR Part 11 compliant tool to manage both sponsor and site binders.

Track kits across hundreds of sites to ensure enrollment continues.

Sites can consent and collect all data electronically.

RDI’s scanner and redaction service makes it easy for sponsors to review records.

Keep track of aliquot details including volume and quality.

System tracks aliquot shipments and builds an automatic freezer inventory.

Export all subject and aliquot data into a CSV file.

Use the system to automatically issue invoices for each qualified subject.

Clinical Trial Site Management

With our remote monitoring solution, you can manage hundreds of sites with complete transparency to source records. This visibility is invaluable when it comes to improving the quality of your data. Our solution allows you to reduce costs throughout the process, from adjusting and guiding enrollment in real time to avoiding multiple costly in-person monitoring visits.

The Remote Monitoring Process

Each site is given a data entry tablet and scanner for medical records.

Data are reviewed, redacted, and monitored by RDI’s staff of CRAs.

Clients view each subject’s data and redacted records in the RDI portal.

IVD research is unique and often complex

Diagnostica

Automated Site Outreach

Digital Site Qualification

Regulatory Binder

Kit Management

Informed Consent + CRF

Medical Records

Sample Tracking

Sample Storage

Aggregated Test Data

Clinical Site and Subject Payments

Clinical Trial Site Management

The Remote Monitoring Process

Technology & Expertise to Support Your Trial