Doctor Evidence & OneSource Regulatory Partner to Expand DOC Label Licensing and Services
SANTA MONICA, Calif., Aug. 23, 2017 /PRNewswire/ -- Today, Doctor Evidence ("DRE"), a technology-enabled clinical health research data provider, announced a partnership with OneSource Regulatory (OSR), a technology-enabled services firm specializing in the regulatory and global labeling market space, to provide a greater breadth of access and options for companies, including additional applications for existing clients of DOC Label to help realize the benefits the solution can provide to their organization. DRE's DOC Label solution enables users to retrieve and compare results from a database of all FDA and UK drug labels as well as any global territory local uploaded label. Innovative teams using DOC Label include regulatory, competitive intelligence, commercial, brand, pharmacovigilance, safety, research and development, and product labeling teams.
The current release of DOC™ Label 2.0 version expands upon the existing DOC™ Label platform with the addition of over 17,500 drug labels from the United Kingdom marketplace through a proprietary partnership with DataPharm.
Upcoming features planned for release in DOC Label 2.0, include a Synonyms Manager and Medical Concept Comparison feature, that further links words found in labels and package inserts to Regulatory dictionaries. These new features incorporate Doctor Evidence machine learning technology into the DOC Label platform and allow for increased use across business units and functional groups enterprise wide.
Doctor Evidence's partnership with OneSource Regulatory enables both small and large companies to be able to access DOC Label and provides an option for clients to leverage best in class professional services based on these advanced technologies and capacity staff augmentation services from OneSource Regulatory. OneSource Regulatory, a leader in providing in Regulatory, Medical and Compliance services and solutions, is uniquely positioned to help clients with the best use and leverage of the Doctor Evidence platform for label formulation, launch and on market Regulatory activities. The OneSource Regulatory team provides Regulatory labeling and promotional services to a large number of large, mid-size, and biotech companies launching their first brand. OneSource Regulatory Co-Founder & Chief Operating Office, Tracy Rockney, JD, has been a longtime industry Regulatory executive for over 20 years and advisor to Doctor Evidence and has acted as their Regulatory Officer in Residency since 2015. Rockney was an early implementer of DOC Label while she was Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion at AbbVie and since she started OneSource Regulatory, Rockney and her team have worked with Doctor Evidence and their clients to identify and prioritize new capabilities for DOC Label and have witnessed the power of the solution across the current broad client base.
"Working with Tracy and the deep domain knowledge of the OSR team regarding Regulatory authorities, brand teams, and the agency community has been invaluable to DRE and our clients," said Bob Battista, CEO of Doctor Evidence. "Companies not using DOC Label across their enterprise or leveraging OSRs best-in-class expertise and services are risking their competitive and regulatory strategies. This is must-have technology and expertise akin to what the combustion engine was over a horse-drawn carriage."
Outside of Doctor Evidence, OneSource Regulatory is the exclusive value-added reseller of DOC Label to pharmaceutical and biotechnology companies. OneSource Regulatory also offers concierge subscription services using the platform to companies who want expert regulatory labeling guidance along with expert DOC Label capability while developing labeling for FDA or EU submission and assistance during FDA labeling negotiations. Doctor Evidence will also provide software development services to OneSource Regulatory for the development of labeling apps, designed to address labeling needs across the pharmaceutical industry.
Tracy Rockney commented, "Our team at OneSource Regulatory is excited to offer services and training for DOC Label as part of our strategic labeling service offering. Our partnership with Doctor Evidence is part of the larger OneSource Regulatory vision to provide technology-enabled services across all of our service offerings - our clients want high-quality services delivered efficiently and effectively, with innovative regulatory options and solutions."
About Doctor Evidence
Doctor Evidence is a leader in technological solutions for Evidence-Based Medicine (EBM) with a mission to support efforts of healthcare providers and patients to gain access to important evidence-based knowledge, based on the most timely and relevant medical evidence and related analytics, to inform clinical decisions and improve the health and wellbeing of patients worldwide. This specialty software and services company's methodology uses a Digital Outcome Conversion (DOC™) approach for transforming data from published clinical studies, epidemiological databases, and other sources, into reusable and updatable databases.
About OneSource Regulatory
OneSource Regulatory (OSR) is a leader in providing in Regulatory, Medical and Healthcare Compliance services and solutions. Utilizing expertise from decades of proven industry experience, OneSource provides the following services:
- Regulatory Affairs
- Advertising & Promotion Review
- Labeling development (TPP, CCDS, and local label development, including the US PI and the EU SPC)
- Chemistry, Manufacturing & Controls (CMC)
- Strategy
- Medical Affairs
- Advertising and Promotion Review
- Review of Independent scientific exchange materials, grant requests, and independent research study proposals
- Commercial Healthcare Compliance
- Monitoring and Auditing
- Policy/Program development
- Data Analytics
SOURCE Doctor Evidence
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