Transactional Content Management

WHITE PAPERS AND CASE STUDIES

• ICH And USP <1220>: Implementing A Quality By Design Analytical Framework

  The ICH and the USP are currently finalizing draft guidelines that describe a new paradigm for analytical development based on the QbD approach used for development.

• Simplifying Tech Transfer With Automated Data Flow

  A pharmaceuticals development team struggling with disconnected and unstructured data sources improved their tech transfer process by simplifying data capture and aggregation.

• Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing

  Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.

• Compliance Tips For New Medical Device Products

  How can you guarantee that your medical device will not only perform as designed, but also conform to the highest regulatory standards? By designing for compliance you can meet this goal.

• Meta Biomed Accelerates Digital Transformation

  Meta Biomed's scientists ran hundreds of experiments, but they lacked a clearly defined way of sharing information and knowledge between individuals and teams. They also wanted to centralize their product development data and achieve a more structured way of working to boost innovation, embed quality throughout the supply chain and accelerate product certifications—especially as they sought to become a leading supplier of surgical sutures in the global market. A single, centralized database solution now allows them to hold all of their product development data.

• Digitizing Your Clinical Drug Development Process

  Review the usage of MES in pharmaceutical manufacturing, through the drug production lifecycle, from preclinical to commercial and consider MES capabilities in the context of clinical needs and priorities.

• Tekton Research Experiences A 'No Findings' FDA Inspection

  As COVID-19 increased its impact on research collaboration and monitoring in 2020, Tekton Research’s desire to move to full remote monitoring intensified. The research site soon realized there was a need for a remote source document monitoring solution --– one that would enable the upload, management and sharing of source documents with monitors and sponsors without redacting sensitive patient information.

• UW Carbone Cancer Center Gains Visibility Into Site Accrual

  Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide. Read how UWCCC was able to enhance their data analytics and visualization capabilities helping them improve operational oversight, especially through greater visibility into site accrual metrics.

• Qualification Considerations For A “Factory-In-A-Box”

  The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive. Enter the "factory-in-a-box," which can be a game-changer.

• How The World's Leading Vaccine Network Reduced Protocol Deviations

  Discover how the world's leading vaccine site network reduced protocol deviations by almost 40%.

• Nanoparticles Drive The Nanotechnology Revolution

  This paper helps to define nanoparticles, their various uses, and the analytical techniques used for their physical characterization.

• The Future Of RBM Software

  With an eye on speed, safety, and efficiency, CROs and sponsors are employing software that offer enhanced capabilities for identifying risks in clinical trials. The broad category of such systems is often referred to as riskbased monitoring (RBM) technology. But even though such systems introduce new monitoring capabilities, too many fall short of delivering the full benefits of RBM.