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WHITE PAPERS AND CASE STUDIES

• Implementation of the New European Health Technology Assessment Regulation (HTAR)

  The European Health Technology Assessment Regulation (HTAR) requires joint clinical assessments for certain therapies starting 2025, impacting market access preparation for companies in the EU.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Revolutionizing Lead Service Line Removal: A Milestone For Detroit's Water Infrastructure

  Detroit, like many other cities across the U.S., has grappled with a silent threat lurking within its aging water infrastructure: lead service lines. Learn why The Detroit Water and Sewage Department partnered with BlueConduit to help make the lead service line inventory and removal process more efficient than ever before.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Leveraging Machine-Learning For SDTM Mapping

  The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) represents trial data in a standardized format for review, but could its preparation be automated?

• What Does Pharma 4.0 Mean To Cell and Gene Therapy Drug Manufacturers?

  Explore the benefits of Pharma 4.0 for CGT companies along with the challenges they may face when implementing the convergence of people, systems, and data within a singular network.

• Tablet Manufacturing Technologies For Solid Drug Formulation

  Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

• Rose Research Center Leans On Medrio To Simplify Workflows And Study Design

  After experiencing paper processing issues, discover how a company transitioned to digital data collection by using Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (ePRO) solutions.

• Professional Annotation For Better AI In Life Sciences

  Discover how the industry has begun leveraging the full potential of its data reserves with the help of artificial intelligence and machine learning.

• The Heroes Of Vaccine Development: Lipid Nanoparticles

  Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.