Turn-key IT Infrastructure for Life Science Start-Ups at Any Stage
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.
LIFE SCIENCE BASIC™ is a fully-compliant, ready-to-use, cloud-based IT infrastructure streamlined for life science start-ups. LIFE SCIENCE LAUNCHPAD™ is all of that, plus a suite of remote desktop and support services. Don’t reinvent the wheel. Don’t risk your business by using non-compliant, general-purpose tools, cobbled together.
With our scalable pricing and expandable architecture, you can have a qualified infrastructure from the start.
Regulated Content for Clinical Trials
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.
Gather documents, faxes, voice files, or videos from various clinical sources.
Access commercially available tools and the most technologically advanced software.
Leverage our fully-incorporated audit logging and security features — critical for HIPAA.
Use our CRO Voice & Video Workbench.
Use web-based capabilities (save money while maintaining a patient-centric approach)… and more.
Leave the regulatory burden to us, so you can focus on your important work.
EDM / eTMF
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.
Migrating Data from CRO Partner to Your Own Site? We can help you make your site be the “Source of Truth.” We’ll push all of your scanned-in content through the Adlib PDF Rendering engine to enable that content to be searchable. With the OCR capabilities of the Adlib engine, we make it possible for you to actually use your data. What a concept!