FEATURES

  • TRIPLE MEDIA RECORDING

    Triple media recording (TMR) ensures a highly compliant informed consent process for patients and investigators. The patient’s written informed consent is documented in TMR through a combination of photos, video and audio recordings.

    TMR sets new security standards and prevents inadequate patient inclusion. The homogeneity of recordings is guaranteed through automated, cutting-edge quality control mechanisms. TMR facilitates the informed consent process for all stakeholders.

  • PERSONALIZED PATIENT EDUCATION

    Multi-media patient education videos are customizable for every study. Multiple content packages can be designed according to particular needs, especially for multi-centric studies. The customized content can be adapted by experts to guarantee full education and information of patients from a multitude of backgrounds. premierConsent® offers tailored 2D and 3D animations and allows for the implementation of content from partnering companies.
  • STAKEHOLDER INFORMATION HUB

    premierConsent® serves as a trial information hub for all clinical trial stakeholders, such as monitors, IRBs, government agencies, and trial sponsors. Different user groups have varying levels of access and information detail depending on applicable regulations. Our team provides 24/7 technical and clinical trial phone support.
  • INTERACTIVE USER INTERFACES

    premierConsent® offers streamlined, easy-to-use interfaces for all system users. The system is intuitive and does not require any specific technical knowledge. Its simple design makes premierConsent® the perfect choice for obtaining informed consent from children and illiterates. The training modules are optimized for study staff and can easily be done in minutes.
  • ADVANCED ANALYTICAL TOOLS

    premierConsent® provides investigators, monitors and sponsors with live, up-to-date data and figures, regarding recruitment, active study sites, document status and relevant study staff information. The system logs all user-related inputs, and offers full traceability of system and user activity. premierConsent® allows sponsors to perform sophisticated analyses on collected data, both, on the individual and study level.
  • CONTINUOUS SYSTEM EVOLUTION

    premierConsent® is a dynamic system which is continuously improved through self-learning mechanisms and adaptations from statistical evaluation outputs. The assessment of response latency of patients allows to adapt the AV content to the patient's need increasing patient understanding and retention. The quality control mechanisms for auditive/audio-visual recordings are self-adjusting and ensure consistent recording of high quality material. This guarantees the production of data to the highest standards for all involved stakeholders.

Advantages

  • Enhanced budgetary control

    premierConsent® offers many features that will impact positively the bottom line of your clinical trial. Through reduced overall trial costs, efficient patient management and clear up-front pricing, premierConsent® creates certainty in anticipated costs and an effective reduction of overall trial expenditures.
  • Optimized patient recruitment

    Through individualized, multimedia patient education, premierConsent® allows every patient to become fully involved in their trial. This understanding reduces patient attrition rates, improves patient participation and insures patient satisfaction.
  • Improved trial monitoring

    With an integrated query function, premierConsent® enables clinical trial monitors full, secure and remote access to pivotal enrollment data. These remote and facilitated monitoring functions improve upon already integrated risk-based monitoring algorithms.
  • True patient centricity

    The patient comes first with premierConsent®. The design of our consenting tool puts patients’ interests at its center. Secure handling of personal identifying information and patient data, individualized attention to patients’ circumstances and needs and intelligent system adaptations based on patient feedback allow for a truly patient-centered consenting process.
  • Solid regulatory compliance

    premierConsent® is the only commercially available consenting tool that provides for audio-visual or audio recording of the written and oral consenting process. This benefit drastically reduces the potential for wrongful, erroneous or incomplete patient inclusion into the study. Above and beyond meeting all regulatory requirements, premierConsent® reduces the risk of downstream inconsistencies and deviations from applicable law.
  • Significant error reduction

    In using premierConsent® all stakeholders are up-to-date on the most recent versions of relevant trial documentation such as protocols, amendments and informed consent forms at all participating study sites. The system provides real-time feedback on each site’s document status. The coordinated efforts of premierConsent® and its support staff ensure smooth and accurate handling of patient information, trial data and appropriate informed consent processes.

"With patient centricity as its core element,
premierConsent® impacts and augments clinical trial safety,
data reliability, regulatory compliance and cost efficiency."

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