Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Patient-Focused Data Capture For Cancer Research

  In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

• Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing

  An integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• The New Industry Migration Framework For FSP

  Review why a functional service provider should be on the top of a sponsor’s list when it comes to choosing a specialized eClinical data management provider for its next study.

• Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments

  During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.

• Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials

  This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.

• 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.

• 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.

• Six Strategies For Accelerating Approval For Cell And Gene Therapies

  As you advance through the evolving regulatory landscape for cell and gene therapies, review these six proven strategies to help sponsors reduce their risk of failure and expedite speed to market.

• IT Changes Implemented To Overcome Future Manufacturing Challenges

  Learn how Pfizer and Ferring improved their reporting and batch information management with Rockwell’s technology.

• 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.

• Cleanroom Recovery. Proven Results. Contamination Control Case Studies

  Through this collection, review how a proven, automated solution can help facilities stay compliant, operational, and protected — whether in a crisis or during planned maintenance.