Maria Picone Email and Phone Number

Founded in 2007, Formed builds health-focused data solutions. The Company helps communities and organizations capture, manage and share information. Designed and deployed in accordance with FDA guidelines on electronic records and electronic signatures (21-CFR part 11), our applications are HIPAA compliant.Formed is currently conducting a private beta for TREND, its community empowerment platform designed to: track diet and other health data, compare outcomes and milestones with peers, generate health trajectories, and test hypotheses using crowdsourced data (trend.community).

I manage project, operational, and strategic ventures in the biotech and pharmaceutical industries.I have extensive experience working with the follwing Enterprise database and document management software:* Oracle;* SQL Server;* Sharepoint; and* Documentum. I am well-versed in the following technical guidelines:* electronic submission of regulatory documents (eCTD); and* FDA guidelines on electronic records and electronic signatures (21-CFR part 11);I hold the following certifications:* Division of AIDS (DAIDS) Human Subjects Protection (HSP) and Good Clinical Practice (GCP), and FDA Regulations Comprehensive Training Workshop; and* Human Research Curriculum: Belmont Report and CITI Course Introduction, History and Ethical Priciples, Basic Instituational Review Board (IRB) Regulations and Review Process, Informed Consent, HIPAA and Human Subjects Research. My specific services include:* document preparation and process management for the electronic submission of regulatory documents (eCTD);* system design, audit and validation in accordance with FDA guidelines on electronic records and electronic signatures (21-CFR part 11); and* development of organization policy and standard operating procedures.

Mozzo Analytics is a "big data" analytics company. Mozzo’s Relevance engine was built to sample massive amounts of unstructured data, identify what is relevant, and present time-sensitive, behavioral information.