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WHITE PAPERS AND CASE STUDIES

• Alzheimer's Study Involving Home Infusions Exceeds Expectations

  Gain insight from this Phase 3 global clinical trial focused on pre-clinical Alzheimer’s Disease where adult patients received one-hour intravenous infusions every month for 4.5 years.

• A Comprehensive Planning Approach For Cancer Antibody

  Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase 1 protocol for an immuno-oncology antibody.

• 3 Ways To Address Sterility Assurance Requirements Of The EU GMP Annex 1

  Learn about the three key proactive steps companies need to take to meet the sterility assurance requirements of the EU GMP Annex 1 for the manufacture of sterile medicinal products.

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.

• Are You Leveraging All Of Your Clinical Data?

  To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

• Research Site Network Enhances Study Startup With Reliable ICF Writing Services

  With help from a new informed consent form (ICF) writing partner, discover how CenExel Clinical Research was able to streamline processes and launch new studies faster.

• Retrofit Of A Brand New Pump Station

  Due to clogging problems, a pump station was experiencing reduced pump performance, longer pump run times, significant vibration issues, and the need to be physically unclogged. 

• Biotechnology Manufacturing Program Management

  Find out how a global biotechnology manufacturing company executing several interrelated projects achieved critical project objectives while adhering to schedule and financial commitments.

• Creating Endpoint Adjudication Committees And Management Strategies

  In complying with regulations, trial sponsors may need expert guidance on best practices for developing an EAC and overall strategy and oversight of key endpoint objectives and processes.

• 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.

• Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape

  Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations

• Gateways To Asia: Market Access In Japan And South Korea

  Learn how the recent developments in market access and regulatory rules in Japan and South Korea have paved the way for expansion in Asia.