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WHITE PAPERS AND CASE STUDIES

• Leading Recruitment With A Strong Alzheimer's Referral Pool

  A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.

   

• In Vivo Testing Of Nasal Dosage Forms

  Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.

• Enhancing Novel Developability Through Automated MS Analytics

  Growing biotherapeutic complexity demands MS workflows that can unify diverse datasets. Learn how automated approaches enhance data quality, streamline analysis, and support faster development.

• Driving Customer Profitability With Enterprise Platform, Pricing

  Explore how the solutions and approaches offered by CDS can help different research stakeholders conduct more cost-efficient clinical trials in the industry's pharmaceutical, biotech, and device sectors.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• White Paper: Spray Drying Biologics: An Alternative To Freeze Drying

  Explore how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• 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.

• Manufacturing Strategies To Industrialize Autologous Therapies

  Discover how a systematic approach to autologous cell therapy manufacturing can reduce costs, improve reliability, and accelerate access to life-changing treatments.

• OPTICHECK Technology Built-In – Diagnostics, Verification, And Functional Safety With OPTIMASS Coriolis Mass Flow Meters

  State-of-the-art measuring devices such as OPTIMASS Coriolis mass flow meters combine robust measuring principles and powerful electronics to produce a wide range of readings and device-specific data. OPTICHECK technology built-in leverages the features of the devices to translate their available comprehensive measuring system data into sophisticated diagnostics information for plant personnel. 

• Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance

  Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.