Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Enabling CDMOs To Focus On Core Priorities

  Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• Handling Demanding Active Ingredients Safely And Efficiently

  See three flexible Optima fill‑finish and syringe assembly systems to boost performance, accuracy, and scalability, enabling efficient processing of diverse formats and supporting rapid CDMO growth.

• Container Selection For A Highly Sensitive Drug Product: A Success Story

  Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

• Metropolitan Sewer District Of Greater Cincinnati

  The Lower Mill Creek Partial Remedy (LMCPR) in Hamilton County, Ohio, is a large, complex effort to remove about 1.78 billion gallons of combined sewer overflows (CSOs) annually from the Mill Creek, an Ohio River tributary. When complete, LMCPR will improve water quality and serve as a catalyst to improve local neighborhoods.

• The EMR Interoperability Dream Vs. Clinical Research Reality

  Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

• Phase 1 Clinical Trial Designs And Strategies

  With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.

• HVLD Technology Pre-Filled Syringe Inspection

  Advanced HVLD technology delivers non-invasive, deterministic inspection for pre-filled syringes. Learn how this method improves reliability and patient safety compared to traditional approaches.

• The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality

  Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.

• The Role Of A Consulting Firm In The IND Process

  Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).