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WHITE PAPERS AND CASE STUDIES

• Implications Of Assessing Overall Survival In Oncology Studies

  New oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.

• 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.

• Advancing Oncology Innovation With Adaptive Trial Designs

  When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Expanding Diabetes-Related Eye Health Equity

  20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.

• Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars

  The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

• Why Early Market Access Planning Is Crucial In CGT Commercial Strategy

  Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• The Patient Recruitment Shift: Navigating Disruption, Delivering Precision

  Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.

• 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).

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.