Compliance

WHITE PAPERS AND CASE STUDIES

• Comparative Analysis For Non-IND Sites

  A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.

   

   

• Support Manufacturing Operations With Process Data Management Software

  Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).

• Distribution Of The First Commercial CAR-T Therapy From USA To Japan

  Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.

• Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
• TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
• Safety First In The Field!

  Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.

• Checkmate International Assures Food Safety Compliance with PointBase Micro Originally, Checkmate relied on a proprietary data storage structure, written specifically to run on Psion computing devices. However, this became difficult to integrate with corporate back-end databases and was prone to data corruption. To resolve these problems, Checkmate has now switched to PointBase Micro, a platform-independent relational database optimized for mobile environments.
• A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
• Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
• The Potential Return On Investment Of Using ePROs Over Paper In Clinical Trials

  Industry perception is that the start-up costs of implementing an ePRO platform may dwarf the cost of printing and distributing paper diaries by as much as 10 times. However, this does not take into consideration the significant value and return on investment that adopting ePRO technology has had on overall clinical trial costs and timelines due to improvements in data quality and completeness, participant retention and compliance, and study and site efficiency.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• Case Study: Workforce Management Solution Supports Smart Meter Rollout During the technology evaluation stage, CHED Services recognized an opportunity to derive further benefits from the launch of a proven enterprise workforce management system. By Ventyx