Pharmaceutical NEWS - Spring 2010

Positive project outcomes through enhanced project management

Outsourcing of laboratory services in the pharmaceutical industry has matured from a temporary cost saving tactic to long-term formation of strategic alliances among partners focused on innovative, timely scientific solutions. As this change has evolved, Lancaster Laboratories has developed project management and communication systems designed to make interactions with clients more seamless and efficient. Because logistical issues can contribute to the cost of managing complex projects, the ability to track and share information between outsourcing partners is a key to success.

As part of the project initiation phase, Lancaster Labs works collaboratively with clients to determine a schedule that will meet their needs. Tools, such as Gantt charts, are used to identify milestones, key activities and required resources. Regular conference calls with the project team are scheduled to review progress, resolve roadblocks and share data via a web interface. Analytical method development and validation require a variety of documents and protocols, many of which need to be reviewed and approved by technical, management and quality assurance personnel at both the client and laboratory locations. This can be a time consuming, repetitive process when multiple parties contribute to editing the documents. Lancaster Labs can reduce these inefficiencies by using secure, webbased interface tools that allow for quick review and editing of the realtime project documents prior to finalization. Features like version control and “track changes” are employed to highlight recent edits and ensure that everyone is reviewing the most current revision. “For clients that want to be involved in their protocol development, reviewing and editing the document together can eliminate going back and forth with drafts. It can save a lot of time,” says Cindy Eby, group leader of the Protocol Development and Technical Support Department.

As projects progress, clients have access to their laboratory data on a real-time basis through LabAccess.com, Lancaster Labs’ innovative, web-based software. Project information, submitted samples, data notebooks, chromatograms, test results, certificates of analysis, summary project reports and invoicing information are all available through this secure, easy-to-use interface. Clients have the ability to perform paperless data audits from off-site locations, which can streamline the process of data gathering, and the system can also be used to share specialized data presentations, such as chromatographic overlays from multiple sample injections. When testing is complete, the laboratory offers a variety of report formats and data deliverables, which can also be customized. While most clients find that LabAccess.com meets their need for a versatile interface with the laboratory, some firms have specific data systems that are an integral part of their operations, and their requirements may include transferring data from the laboratory data system into the client data system. Collecting chromatography runs and entering data directly into client LIMS are among the requests that Lancaster Labs has successfully answered.

In addition to laboratory data, Lancaster Labs can provide performance measures to verify that positive project outcomes are obtained. Metrics such as test turnaround time, report generation, investigation summaries and invoicing reviews provide ongoing management information that can be used to diagnose problems and identify barriers to successful collaboration. By tracking these indicators for clients, Lancaster Labs ensures that both technical and administrative project elements are under control.

“As the variety and complexity of outsourced tasks increase, we’re finding that projects have to be managed differently to ensure positive project outcomes for our clients,” says Jon S. Kauffman, Ph.D., director of Method Development, Validation and Biopharmaceuticals.

Dr. Jon S. Kauffman, director of Method Development & Validation and
Biopharmaceutical Services; Dan Peckman, group leader of Biochemistry;
Kelly Morris, Pharmaceutical Client Services; and Cindy Eby, group leader
of Protocol Development, review Gantt Chart of Milestones for large
drug development projects.