WHITE PAPERS AND CASE STUDIES

• Successful SwissMedic Marketing Authorization Application For An Oncology Therapy

  See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.

• Mobile App And Wearable Integration Collects Longitudinal Data

  Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.

• AMERICAN Plays A Role In Rebuilding Puerto Rico's Infrastructure

  AMERICAN is helping rebuild Puerto Rico’s vital water infrastructure after Hurricane Maria, supplying American-made products to strengthen resiliency for 3.5 million residents and millions of annual visitors.

• Driving A High-Adherence LTFU Trial Without An EDC

  Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.

• Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration

  Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.

• Illumina Fortifies Supplier Relationship With Digitalization

  Illumina improved its quality management by adopting digitalization, enhancing supplier collaboration and efficiency in monitoring, while transitioning from rigid manual processes to a streamlined, integrated system.

• Guiding GLP-1 Participants Through The Challenge Of Retention

  Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.

• Rapid Assessment Of Fab-VHH Expression

  Find out how a 10-day expression screening program rapidly identified optimal gene orientation for a bi-specific antibody fragment fusion, achieving up to 570 µg/mL soluble, active product.

• Feasibility Insights In HR+/HER2 - Metastatic Breast Cancer

  This case study showcases how advanced analytics were used to streamline feasibility planning for a Phase II clinical trial targeting HR+/HER2- metastatic breast cancer as a second-line treatment.

• Condition Assessment At Spring Creek Ranch

  Learn why Spring Creek Ranch chose Echologics to survey 1.7 miles of 12-inch ductile iron pipe, utilizing the ePulse® method to assess the condition of the over 40-year-old pipes.

• Aseptic Expertise And Delivery Of Services

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• Transforming Clinical Supply Planning From Spreadsheets To Smart Forecasting

  Streamline your clinical supply forecasting and reduce risk by moving beyond manual spreadsheets to an integrated, real-time supply management solution.