SHIFT YOUR COMPLIANCE BURDEN TO US

By leasing space in our Audit-Ready Compliant-Cloud you will have access to an intelligent ecosystem that will automatically administer audit ready compliance to all of your work products.

  • Access to the pre-validated tools you need for:

    • e-Submissions

    • Clinical Trials

    • Document Management

  • No Systems Administration

  • No Capital Expenditures - Just Low Cost Monthly Subscriptions

  • Monthly Leases

  • Professional Services & Custom Integration Available

We’ve already executed the IQ/OQ/PQ on these tools so that you don’t have to.

E-SUBMISSIONS

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ETMF

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EDMS

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ESG Gateway

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QUALITY ASSURANCE

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IQ-OQ-PQ

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CORRECTIVE AND PREVENTIVE ACTIONS [CAPA]

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TRAINING

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STANDARD OPERATING PROCEDURES [SOP]

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DEVIATIONS

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CLINICAL TRIALS

Introducing CRO Voice and Video Workbench

A powerful combination of GoToMeeting, GoToWebinar, GoToTraining and OpenVoice

Completely wrapped in an audit-ready compliant cloud (ARCC) that meets FDA 21 CFR Part 11 requirements.

Leverage the flexibility of mixing and matching the world’s leading voice, video, and training solutions while enhancing patient centricity, mitigating risk, and ensuring FDA compliance.

VIDEO TRIALS

Patient-Centric Video Data Capture

REPLACE or augment on-site case report forms with remote voice and video data capture

GATHER patient and clinician interactions in a way that reflects a personal touch

TAILOR the capture of trial data in a more flexible way, enhancing patient comfort

INTERVIEW each patient remotely in the privacy of their own home

KNOW the focus on new patient data capture methods will not reduce trial standards

VOICE TRIALS

Patient-Centric Voice Data Capture

REPLACE or augment on-site case report forms with remote voice and video data capture

GATHER patient and clinician interactions in a way that reflects a personal touch

TAILOR the capture of trial data in a more flexible way, enhancing patient comfort

INTERVIEW each patient remotely in the privacy of their own home

KNOW the focus on new patient data capture methods will not reduce trial standards

VIRTUAL INVESTIGATOR MEETINGS

PROTOCOL amendment updates easily distributed to all your sites

QUARTERLY and annual refresh of procedures to keep staff up to your high standards

REMOTE clinicians when procedure allows, to reduce increasing travel costs

BACK UP process for clinicians who miss a primary meeting