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Clinical trial tips from Bristol-Myers Squibb

What’s new, what’s now, and what’s happening in Clinical Trials Materials (CTM) was the subject of an October 25 educational session held at the 2004 ISPE Annual Meeting in San Antonio featuring Bristol-Myers Squibb.

The Intl. Society for Pharmaceutical Engineering is a global, not-for-profit membership organization that provides education, training, and technical publications to life science professionals. The session included advice from Paula Mastrangelo, associate director of clinical supply operations, Bristol-Myers Squibb (BMS), New Brunswick, NY on electronic batch records.

Her presentation, "E-Batch: A BMS Electronic Solution to Batch Execution and Disposition," looked at the company’s labeling and global outsourcing experience with batch records. The key factors to consider when selecting an electronic solution were based on the company’s experience in using a technical team that involved BMS clinical packaging in Canada, the United States, and the United Kingdom. The considerations were as follows:

  • Develop a solid project framework with a team of global members made up of professionals from quality assurance, technical experts, and project leaders from technical and business areas.

  • Develop user requirements and project scope documents, and a project plan.

  • Develop an approach with prototypes to be evaluated from all sites to allow feedback.

  • Identify resource requirements and risks, and develop finalized budgets.

  • Develop a master recipe of instructions with materials for a specific operation.

    Benefits of a successful plan

  • Improves overall quality

  • Reduces execution and documentation errors

  • Allows review of batch record entries immediately

  • Reduces cycle time by not passing paper records

  • More efficient use of labor and equipment

  • More standardized guidelines

    Lessons learned to improve the next program

  • Maintain communication throughout the project with all involved

  • Don’t underestimate time and resource requirements for detailed design documents and system and user acceptance testing, for relations with vendors, user acceptance testing, and hands-on training

  • Spend sufficient time and resources up front

  • Perform frequent "reality checks" and adjust plan as necessary

  • Consult with experts

    For more information on The Intl. Society for Pharmaceutical Engineering, visit

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