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WHITE PAPERS AND CASE STUDIES

• Multidisciplinary Team Accelerates Immuno-Oncology Approval

  In this in-depth case study for an immuno-oncology program, learn how multidisciplinary development strategy assessment reduced a sponsor’s risk, controlled expenses, and optimized speed to market.

• Creating A Biosafety Cabinet Training Program

  This article provides information for creating your Biological Safety Cabinet (BSC) training program, a list of resources and videos, and how your BSC manufacturer could provide additional resources.

• How One Biotech Leveraged Advanced Preclinical Studies

  BriOri Biotech used cutting-edge technology to achieve the sensitivity and reduced carryover needed for analysis of reformulated COX-2 inhibitor.

• Secure The Cell Therapy Supply Chain From Bench To Bedside

  While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. 

• IT Changes Implemented To Overcome Future Manufacturing Challenges

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

• The Future Of The FDA: Operating In An “Electronic World”

  Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

• TargetCancer Foundation Successfully Engages And Empowers Rare Cancer Patients

  Delve into how the TargetCancer Foundation implemented a remote consent function in their TCF-001 TRACK study with an objective to determine if rare tumors can benefit from matched molecular therapy.

• Clinical Supply Optimization: Process Improvement Accelerates Trials

  A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.

• Planned Emergency Research And Exception From Informed Consent

  This white paper focuses on key issues of interest to sponsors who may be interested in planning and designing EFIC studies, sites and investigators conducting EFIC research, and IRBs charged with reviewing EFIC studies.

• Modernizing Clinical Data Management To Be Scalable, Flexible, And Intelligent

  This white paper provides a brief summary of why clinical data management CDM must quickly adapt to the mounting data pressures in modern clinical trials.

• Liposomal And Nanoparticle Technology

  Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

• Patient Recruitment: A Critical Component Often Overlooked

  One of the biggest and most often overlooked aspects of a study is that of Patient Retention (PR). To better understand the dynamics of PR, the patients’ behavior drivers need to be explored.