CDISC awarded contract for training of FDA reviewers
The Clinical Data Interchange Standards Consortium (CDISC), announced that the FDA has selected it, via a formal RFP process, to provide training to FDA reviewers of regulatory submissions. The courses to be taught over the next two years will include CDISC Basics, the CDISC Study Data Tabulation Model (SDTM), the CDISC Analysis Data Model (ADaM) and Advanced Topics on CDISC Standards. CDISC and its member partners for this training – Octagon Research Solutions, Destiny Corporation and Maximum Likelihood Solutions – will provide classroom as well as web-based virtual training for the requested courses.
Nextrials expands its executive team
Nextrials Inc. has added Robert Barr and Michelle Dockhorn to its executive staff. In his new position as chief technology officer, Barr will be responsible for the continued features and capabilities expansion of Prism, Nextrials’ flagship clinical trial management software and electronic data capture solution. He is the former VP of software engineering for ClinPhone. In the newly created position of VP of global sales and marketing, Dockhorn will direct Nextrials’ business initiatives and communications strategy. For more than 15 years, she has served in many operations, marketing and sales roles in the pharmaceutical industry, most recently as the VP of global sales and marketing at Focus Bio-Inova and IBT Laboratories.
ACORN appoints Tara Webb senior director of CRO business development
Accelerated Community Oncology Research Network (ACORN), a national oncology-focused contract research organization (CRO) and clinical trial network, has named Tara Webb as senior director of business development. Edward J. Stepanski, COO of ACORN, said in a press release: "[Webb’s] responsibilities at ACORN CRO will include presenting ACORN's capabilities to pharmaceutical companies and emerging biotechs, forging alliances with key accounts and providing customer service oversight on behalf of clients." Most recently, Webb served as senior director, business development, for i3 Statprobe, where she was responsible for developing new business opportunities and strengthening current client relationships both nationally and internationally.
Good Products and Adlib Software partner in pharmaceutical regulatory submissions
Good Products, a provider of enterprise content management solutions for the pharma, biotech and medical device industries, and Adlib Software, a producer of server-based document conversion, recognition and publishing software, announced an OEM partnership that aims to facilitate regulatory submissions in the pharmaceutical industry and will see the integration of Good Products' electronic document management system g-docs with Adlib Software's Express Server centralized PDF rendering tool. Using the new integrated system, pharmas will be able to store, manage and track regulatory documents and create high quality regulatory submission-ready PDFs with bookmarks and hyperlinks. Read the press release.
Paradigm Spine to implement PharmaPros’ automated trial management solution
Paradigm Spine, a provider of non-fusion and fusion spinal implant solutions, has entered an agreement with PharmaPros to implement the company’s automated trial management solution, Dataflow Manager, for its coflex IDE clinical study and future studies in its pipeline. The product will provide Paradigm Spine with one central interface through which to track and manage all of the clinical information for its study, including clinical data, safety data, medical images, site performance metrics, regulatory documents and reimbursement data.
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