You’re a life science start-up with limited IT resources. You know compliance is important, but it feels like a burden. We can help. End User Laptop / Workstations pre-configured with specified applications – ready to ship.
As a Sponsor or CRO, you can’t afford to risk non-compliant methods for gathering regulated content from clinical sites, or collaborating with multiple external contributors. Our RegDocs365 environment, fully 21 CFR Part 11 compliant, can be tailored for your specific needs.
Your regulatory department knows what’s involved in preparing submission ready documents. With our DIA EDM and eTMF reference model libraries, you can accurately apply the appropriate metadata to all your documents.
You can also maintain site specific areas, conforming to the models that you require, to interface with current eCTD software. Submit your own data (using links we provide to the FDA Gateway), or tap our service partners to submit for you.
Learn more about ARCC at CourtSquareGroup.com
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