SHIFT YOUR COMPLIANCE BURDEN TO US

By establishing your private cloud environment 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

  • Replace Box or DropBox with a Life Science specific repository for content management

  • 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

Based on the DIA eTMF reference model, the R365 eTMF solution creates a content repository for all your eTMF data either that you gather yourself or migrate in from your CRO partners. Serves as a single source of Truth for all eTMF data.

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EDMS

A content repository based on the DIA EDM reference model, this repository will capture all of your eCTD data in preparation for any submission activities to be executed. Linked in with industry standard eCTD viewer tools you have a low cost solution for managing your eCTD content.

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ESG Gateway

We can either connect to your established ESG Gateway or if you have never created a gateway then we can establish one for you and perform the submission activities for your team.

QUALITY ASSURANCE

By performing your Quality Assurance work in our Audit Ready Compliant Cloud, your work product is automatically compliant with 21 CFR Part 11 regulations.

IQ-OQ-PQ

We validate your solution so that you don’t have to. We qualify the infrastructure and validate your configuration so that you can be assured that you will be audit ready.

CORRECTIVE AND PREVENTIVE ACTIONS [CAPA]

Built in CAPA capabilities within the QMS module provides a seamless connection with SOP and Training management.

TRAINING

Our Training modules are tied to both the Quality and SOP management modules so that you have a seamless method of keeping your training records and curriculum tied to your evolving environment.

STANDARD OPERATING PROCEDURES [SOP]

Our SOP modules provides an environment tied with our Training and Quality Modules so that you can be assured that as you create working documents and put them through the approval process that they will automatically tie in with any “Read and Understood” requirements that you may have.

DEVIATIONS

Tied with the overall QMS module you will be able to identify deviations from your existing procedures and track them through to completion via the CAPA process.

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