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PRODUCTS

  • The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

  • PCI offers a broad range of services to address the manufacturing needs of our clients at each stage of the product lifecycle. Central to PCI’s international service offering is our capability to manufacture a range of dosage forms in compliance with current GMP standards.

  • Reliable, reproducible, easy testing - why wait days to get results?
    The GeneDisc Rapid Microbiology System helps to provide microbial test data in as little as two hours, using a simple to use, robust and cost effective platform based on quantitative Polymerase Chain Reaction (qPCR) technology. Using the GeneDisc Rapid Microbiology System represents an attractive alternative to existing microbiological methods.

  • AST’s ASEPTiCell® is a flexible fill/finish systems that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

WHITE PAPERS AND CASE STUDIES

  • Lucky CRAs. Getting Automated To-Do Lists For Targeted SDV

    Data managers at Lotus Clinical Research used to spend hours each week building reports to identify the patients and forms that needed Source Data Verification (SDV) at the next site monitoring visit. To tackle the problem, Veeva Vault EDC introduced QuickView, a dynamic interface that optimizes the display of data by function, allowing users to focus on what matters most.

  • Swimming In A Data Lake Of eCOA Wearables

    We all know there is a significant increase in data collected from wearable sensors, but what does that mean for eCOA? This whitepaper examines the considerations of adopting these sensors as an addition to the typical Clinical Outcome Assessment (COA) tools used routinely today.

  • Guidance For Remote Monitoring For Sponsors And CROs

    Guidance for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.

  • Industry Best Practices For Novel Biotherapeutic Entities

    As this next wave of antibody-based therapies gains momentum, biochemists have begun to create even more innovative molecules with additional modes of action including multispecific antibodies and other so-called Frankenmolecules. However, informatics technologies have not kept pace with these scientific innovations. It’s unlikely that any single life science company, technology vendor or academic group will be able to solve these issues unaided. But together we can establish systems and processes that make working with these new entities more efficient.

  • Recombinant Collagen Via Fermentation: Safety, Sustainability, Acceptability

    The production of recombinant collagen made via fermentation-based processes addresses the market need for collagen that is safe, sustainable, reproducible, and acceptable to consumers.

  • Local Lab Normalization

    Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.

  • Increasing Entry To Market For A Multinational EPC

    Murry & Roberts is a multinational project life cycle group based in South Africa that has been optimizing client's fixed capital investment for more than a century. They have utilized the design generator for the past 2 years to accelerate their entry to market.

  • Digital Lab Documentation - Improve Collaboration, Productivity, & Reduce Costs

    Laboratory organizations need an environment that facilitates and optimizes collaboration, experiment execution, documentation and data management in the different labs from R&D through manufacturing to commercialization. By implementing a digital lab solution you can bridge the innovation and productivity gaps in research, development, manufacturing and quality, and enable successful technology transfer across new product development and production operations.

  • How To Avoid Last Minute CMC Roadblocks To Approval

    Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

  • The Resilience Of Cash In A Digital World

    Cashless proponents have sounded the death bell for cash for at least two decades, but their predictions have been premature. To be sure, digital forms of payment have received a boost in recent years but have not succeeded in completely displacing coins and paper money. Its unlikely cash will be replaced anytime soon – if ever.

  • CFO’s Guide To Field Service Management Software

    Service-driven companies are being tasked with not just creating revenue growth, but generating more profitable revenue growth. Learn how field service management software can enable top-line revenue growth, improved customer retention, and a recurring return on investment.

  • Making The Medicine Go Down: Specialized Delivery Technologies

    In this article, Sandra Conway, Technical Lead at Pfizer CentreOne discusses some of the drug development technologies that provide a more specialized approach to oral dose delivery.

NEWS