Compliance

WHITE PAPERS AND CASE STUDIES

• 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).

• Regulatory Compliance: Weighing In Pharma Manufacturing

  Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.

• 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.
• 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.

   

   

• Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
• Leveraging AI For TMF Classification To Improve Quality, Consistency

  Explore diverse AI methodologies, such as natural language processing and machine learning, elucidating how they seamlessly integrate with current systems to elevate efficiency and uphold quality standards.

• WIMAX With Differentiation By Elvis Tucker, Aperto Networks The WiMAX Forum defines the profiles that any WiMAX-compliant broadband wireless access systems must support in order to achieve inter-operability. But while inter-operability is an important goal for any WIMAX-compliant system, it will not ensure optimization. Submitted by Aperto Networks
  
  
• Security In The Supply Chain

  When analyzing a transportation company regarding its capabilities to keep cargo safe from theft, there are a variety of questions that a decision-maker should ask in an effort to effectively measure the security skills of the carrier.By FedEx Custom Critical

• Virtual Study Yields High Compliance & Retention Rates

  Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.

• 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
• An Equitable Way To Meet On-Site Business Needs

  Tackling high turnover and employee equity challenges is a priority. Learn how an on-site insourcing solution can provide a stable and motivated team, ensuring project success.

• 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.