Healthcare

WHITE PAPERS AND CASE STUDIES

• 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).

• Innovation In Filtration

  Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.

• Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration

  Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

• Best Practices For Sterilization Validation In Medical Device Manufacturing

  Sterilization validation ensures medical device safety by confirming sterility through rigorous testing, method selection, and regulatory compliance, using both established and emerging sterilization technologies.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• Trial Rescue: Leadership Approach To Propel Clinical Development

  Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

• 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.

• A Guide For Quality Professionals In Healthcare And Life Sciences

  Discover a guide for quality professionals that highlights essential principles and strategies for maintaining data accuracy, compliance, and innovation to ensure high-quality data in healthcare and life sciences.

• Overcoming Participant Compliance Challenges In A Medical Device Study

  Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.