Compliance

WHITE PAPERS AND CASE STUDIES

• 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.

• Adopting Label Change Best Practice To Promote Clarity And Compliance

  Globalized clinical trials are quickly becoming a pre-requisite for success. Read Almac’s latest case study to learn how one sponsor was able to extend its trial into new countries without risking labelling non-compliance, which enabled them to continue on their mission to improve the health outcomes for millions of patients.

• Preparing For Post-Market Clinical Follow-Up Under EU MDR

  Gain a better understanding of the primary challenges faced by the life sciences industry's commercial model in response to the updated EU MDR guidelines.

• Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

  Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

• GFI Case Study: GFI MailEssentials & GFI MailArchiver Machine Solutions Inc. an Arizona-based manufacturer of medical product testing equipment, was faced with two email-related issues: first, the ever-increasing volume of spam that was reaching the company and second, the problems associated with cumbersome .pst files and the lack of a real-time archiving system.
• Mobile-Enabling Logistics: Turning The “Last Mile” Into Aa Competitive Advantage

  When it comes to supply chain, the final process of actually delivering the goods can make or break a company. The impact associated with the delivery process affects margins, customer relationships, repeat business, and cash flow. The paper-laden delivery confirmation process often involves capturing key data and customer signatures, and then handing the paperwork to an admin for processing once the drivers are back at the office. This greatly impacts time to invoice, receiving of cash, revenue recognition compliance, and data quality.

• Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

  The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

• 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.

• Accelerated Development Of Solid Oral Dosage Formulation For IND Submission

  This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.

• Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
• Software Automation In The Blood And Biologics Industry

  Explore the different categories of solutions available to improve process efficiencies as well as the needs and wants that they address.

• California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...