A small biotech company partnered with Chiltern to perform full services across over 15 projects for their entire clinical program in retinal indications starting at Phase II.
It’s a chilling fact: One irresponsible company could seriously damage, or even destroy the biosimilar field. A single company cutting corners with under-regulated, lower-quality development could create an inferior product that harms or kills patients.
Technology continues to advance at almost breakneck speeds. Not only are these advancements surpassing anything we could have imagined just 10 or 20 years ago, they are touching every professional field, including Life Sciences. More advanced computers, displays, and software programs are replacing paper, cards, files, and binders in libraries, banks, and professional offices around the world. Yet despite a clear need and desire to move in a paperless direction, clinical trials still lag far behind other highly regulated industries.
Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.
At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.
FDA and other federal agencies are bound by the Plain Writing Act of 2010 to use “clear government communication that the public can understand and use.” It seems ridiculous that we’d need legislation for such a thing, since “understandable” and “useful” are such obvious and fundamental attributes of communication. There’s even a companion document, the 118-page Federal Plain Language Guidelines (FPLG). By Laurie Meehan, Polaris Compliance Consultants, Inc.
Subject compliance is a hot topic in the industry right now. Some of the discussions out there can be a little misleading since ‘compliance’ means different things to different people / companies.
This paper discusses some of the challenges of traditional paper-based TMFs and provides details about PhlexEview, Phlexglobal’s eTMF system. It also suggests a new approach to TMF compliance that extracts and sets the expectation for continuing value from TMF content, rather than locking it away in paper storage where its value is minimized. By Karen Redding, Global Business Development Director, Phlexglobal, Ltd.
PhlexEview supports compliance and collaboration by leveraging industry standards and making TMF content available to users, regardless of their location. The ability to access and view TMF content at any time transforms sluggish and inert paper processes and helps organisations to realize time and cost savings by reducing travel costs, positioning team members to proactively identify compliance issues and implement corrective actions and by facilitating global collaboration.
This case study illustrates how robust non-clinical advice and consultancy can expedite and accelerate drug development and increase the likelihood of regulatory acceptance
for development programs.
In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
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