FDA Meetings: When More Meetings are a Good Thing!
Most of us are trying to simplify our schedules and remove meetings from our calendars. However, there is one scenario where the potential for more [click to read the full story]
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The Sky is Not Falling: Product Development Can and Should Progress During The Government Shut Down!
The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken [click to read the full story]
DMS, Document Sharing & eRoom Technologies: What’s Right For You?
By Ken VanLuvanee Recently in our conversations with sponsors, we’ve seen a significant uptick in clients using electronic means beyond just storage on hard drives [click to read the full story]
The Myth of Being Special
by Lisa Jenkins VanLuvanee I believe that people are special. They are a unique combination of both intrinsic factors and external experiences. Even identical twins [click to read the full story]
Developing Therapies In a Lean Organization Using On Demand Expertise
By Ken VanLuvanee There appear to be two diverging strategies emerging in the life sciences industry these days – mega-consolidation (mergers and acquisitions) aimed at [click to read the full story]
Document Management for Small Teams, Part 3: COMPLIANCE
by Bruce Salkovitz Introduction This is the third in a series of blogs that look at the essential requirements for document management solutions for small [click to read the full story]
Document Management for Small Teams, Part 2: SECURE
by: Bruce Salkovitz Introduction This blog is second in a series that describes the essential requirements of a document management solution for small life sciences [click to read the full story]
Document Management for Small Teams, Part 1: SIMPLE
by: Bruce Salkovitz Simple, Secure, Compliant. Small life sciences teams produce and manage a great deal of R&D documentation. Their development partners and other external [click to read the full story]
The Future of Post-Approval Change Management
Reproduced with permission from DIA North America. You can see the original here. By Sarah DeMare, Facet Life Sciences Quality by Design (QbD) was introduced [click to read the full story]
Electronic Requirement, Are You Ready?
The Food and Drug Administration Safety and Innovation Act (FDASIA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions [click to read the full story]