All your endpoints. One solution.

Electronic data capture (EDC) system

Gather complete, consistent, and compliant data in an EDC-system designed to work for you.

Trusted by sponsors the world over: The UNITY platform is a comprehensive, 21 CFR Part 11-compliant EDC-software that automatically improves data quality for clinical studies.

Below is a comprehensive list of features as well as essential information regarding EDC.

Configure the UNITY platform to collect validated ePROs from diverse medical specialities, automatically compute scores, and seamlessly link sponsors, sites, and patients.

eCRFs

Design eCRFs that resemble paper-based forms and include automatic edit checks and input validation.

Custom Questionnaires: PREMs, AE forms, and more

Create custom questionnaires, such as electronic patient-reported experience measures (ePREMs) or AE forms, using UNITY’s questionnaire designer.

An EDC-system sites will thank you for.

The UNITY platform from RAYLYTIC automates communication between sites, sponsors, and patients to streamline your clinical study operations.

Generate powerful real-world evidence in a flexible EDC-system

The EDC-system in our UNITY platform is designed to automatically capture data directly from the sources that matter most to your study.

  • Sponsor-initiated registries for continuous RWD collection

  • Internationally accepted

  • Compliant with EU and US data privacy regulations 

  • Integration with popular EHR, appointment, ERP, lab, archiving softwares

  • Configurable integration layer to merge data between HIS systems and UNITY

  • Bridge between HL7 v2/3/CDA to FHIR

  • Bi-directional interface

  • Exports in neutral CSV format for easy consumption by SAS, Excel, or other applications

  • Profiles, mappings, and APIs to fit your master data management needs

  • Questionnaire designer

  • Customizable eCRFs, ePROs, AE forms, ePREMs, or anamnesis forms

  • Sponsor-specific questions for logging protocol deviations in eCRFs

  • Unscheduled AE questionnaire/form/protocol deviations

  • Multilingual questionnaires with no changes in user experience

  • Database design via drag-and-drop

  • Self-serve database and protocol amendments with no downtime

  • Unlimited database size

Manage multicenter studies with ease

Monitor large-scale studies with real-time reporting, adjustable alerts, and rich visualizations of study progress: Our EDC-System integrates seamlessly with our CTMS.

  • Automated export of ePRO data to third-party registries (e.g., SIRIS, DWG)

  • Real-time data quality analysis and validation

  • Event- or time triggered alerts, notifications, reminders, data submissions and reports to automate administrative tasks

  • Automated edit checks involving multiple data fields and datasets

  • Automated cross-check of information within and across eCRFs, ePROs, and other questionnaires

  • Separate environment for conducting validation

  • Configurable email alerts based on customizable criteria e.g.,

    • Advance information to sites about upcoming patient visits

    • Data values for certain form submissions

    • Study completeness notifications

    • Alerts based on patient reponses to questionnaire items

    • Initial invitation and automated reminder alerts to automate communication with patients

  • Dashboards showing study progress, upcoming tasks, data status

  • Customizeable reports on overall enrollment (per study and/or site), data completeness, notifications

  • Scheduled or ad-hoc reports and exports

  • Source data verification with variable granularity (e.g., field, page, form, patient level)

  • Electronic investigator and patient signatures in compliance with 21 CFR Part 11

  • Medical coding using standard dictionaries e.g., MedDRA, RadLex (others upon request)

  • Assign medical codes to verbatim terms on existent data

  • Auto-coding, synonym lists, detection of coding conflicts

  • Display of all open and resolved queries

  • Simple query communication and resolution process

  • Adjustable user interface for patients

  • Design and user interface automatically adjust to device

  • Data entry via tablet, mobile phone, upload of source and archival documents

  • Comprehensive electronic data capture training

Remain compliant with confidence

RAYLYTIC’s UNITY platform is innately compliant and fulfills the most stringent regulatory demands.

The ePRO module “UNITY Outcome” is a class I medical product in Europe according to the European Medical Device Regulation 2017/745/EU, and the EDC module is FDA 21 CRF Part 11 compliant in the United States.

  • All system interactions are 100% audit-logged

  • Exportable audit trails in PDF format

  • FDA 21 CFR Part 11 compliant

  • GDPR-, GCP- and HIPAA-compliant

  • ISO 27001 and ISO 13485 certified

  • SaaS architecture with ISO 27001-certified data storage and ISO 13485-certified business processes

Start collecting ePROs and ePREMs in clinical routine

Our free checklist summarizes the most important technical requirements for integrating ePROs and ePREMs into clinics.

Must-knows about EDC-systems and eCOA

The use of electronic data capture (EDC) and electronic clinical outcome assessment (eCOA) for clinical trials has grown significantly in the last two decades. But as more solutions have come to market, the lines between EDC systems, eCOA, and ePRO have blurred increasingly.

While often used synonymously, electronic data capture (EDC) and electronic clinical outcome assessments (eCOA) actually represent two different pathways for collecting clinical study data and integrating them into a database.

EDC data

EDC data is entered into the study database by study coordinators, clinical research associates, or data managers. These data may be collected either purely electronically or be transcribed from a paper-based case report form (CRF) into a corresponding electronic form. While these data are ultimately sourced from patients or study participants, clinical study staff are responsible for getting it into the database.

eCOA data

eCOA data, however, is collected directly from patients, doctors, or caregivers. Unlike EDC, study coordinators do not act as intermediaries for transferring the data into the database.

Another difference between eCOA and EDC is their functional complexity. Due to a CRA or data manager’s need to fine-tune the consistency and quality of data, EDC systems offer more options for querying, comparing, and reviewing data. eCOA modules, on the other hand, generally possess a more streamlined interface designed to help participants navigate the software and fill out questionnaires accurately and entirely.

The function of edit checking is one way to illustrate this difference. Edit checking in an EDC module gives a data manager more options for constructing input limitations, verifying data, and cross-checking data between different forms and questionnaires. Edit checking functionalities in an ePRO, however, are geared toward guiding the patient to fill out a questionnaire completely and accurately.

How RAYLYTIC customers profit from our solutions:

The UNITY platform is easy to use and the collection of PROMs/CRFs is robust in daily use. The automatic anonymization of the uploaded image data and their statistical analysis are also extremely helpful.

PROF. MICHAEL PUTZIER

Chief Senior Physician at the Center for Musculoskeletal Surgery/Charité Berlin

UNITY facilitates getting patient data and outcome measurements to a higher level. The system is easy to use, the image upload is smooth and complete data analysis is provided quickly and thoroughly, including discussions and advice for improvement.

DR. NANCY LAMERIGTS

Former VP of Research and Marketing at Emerging Implant Technologies

The RAYLYTIC team is extremely competent, diligent and fun to work with. They solve problems and offer support wherever it is needed to get a project up and running. We have already set up multiple studies with RAYLYTIC and are also cooperating on several other projects.

DR. ANDREA WEILER

Director Medical Scientific Affairs at Aesculap/B. Braun

We have built databases for two retrospective studies including image analyses with RAYLYTIC. They helped with designing the eCRF, implemented and trained us on how to navigate the database, provided necessary documents and went above and beyond to help us achieve our goals. Working with RAYLYTIC is fantastic. The team is highly professional and extremely knowledgeable on how to run clinical retrospective studies.

DR. LAMIA BOSLI

Manager Clinical Data Management at RQMIS

RAYLYTIC has created a product that includes all the elements I need for my research, with the highest quality and integrity. In addition, the best part of this product is actually the customer service. I cannot stress enough how impeccable the entire team at RAYLYTIC is, which ultimately makes this product even better.

LINDSAY OROSZ

Senior Manager Clinical Studies at Virginia Spine Institute

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