Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• 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.

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• 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.

• 2025 Trends In Patient Recruitment: From Disruption To Precision

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

• The Essential Role Of Adjudication Technology In Clinical Trials

  With adjudication, learn how teams can enhance the quality and integrity of their research, paving the way for impactful and reliable outcomes in clinical research.

• 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.

• Controlling Trace Impurities In Chemically Defined Media

  Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.

• Applying A Platform Approach To Bispecific Antibody Development

  Explore how experts were able to adjust a mAb production and purification platform to be applicable for the rapid development and scale up of a BsAb.

• The Foundation Of Peak Performance

  In this case study, read about an underdrain system that continues to operate as expected after 16 years of operation and appears to be in perfect condition. 

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.