Situation
A large biopharmaceutical company has multiple labs in various regions around the world that receive large quantities of samples from many different clinical studies every day. The company needed to upgrade its lab processes, which were primarily paper-based and supported by an outdated SQL LIMS, to more efficiently handle the samples.
Before the STARLIMS project got underway, samples from multiple clinical studies arrived at the lab with a paper requisition form and were then checked into a BioMicroLab instrument that printed out details of sample volumes for each. The lab had detailed aliquoting plans for each clinical study, and the samples would be prepared based on those aliquoting plans. Aliquoting is done manually or automatically by instruments, and then the parent samples are moved to storage and aliquots are moved to shipping boxes to be transferred to various testing groups. Keeping track of this process on paper was inefficient and had an increased risk of human error. Implementing the STARLIMS product would solve these issues for the client.
CSols Inc. and STARLIMS partnered to implement the STARLIMS Life Sciences v11.1 LIMS for the client based on a shared history of successful STARLIMS development projects completed together. The work is a large, multiyear project with resources from various STARLIMS partners and contractors. Besides CSols and a large delegation of developers from the STARLIMS core team, another consulting company provided development support.
Objectives and Challenges
The goal of this project is to provide new STARLIMS features and interfaces to meet the client’s requirements and to modernize the LIMS for the laboratories at five sites. The enhancements will be applied to the Clinical Trials Manager application so it can include a new Aliquoting Plan and Workflow functionalities. The company also wants to add new LIMS capabilities to support a high volume of clinical trial studies and samples. Several features and enhancements being developed for this project will be part of the upcoming new features to be released for the STARLIMS Life Sciences product.
Critical and difficult bugs/issues arose periodically. The CSols developers were able to resolve them in conjunction with the STARLIMS project manager and the lead developers.
There were occasional interruptions to the client’s workflows because the project is resource-constrained and work must be done when resources are available.
CSols’s Role in the Solution
The project required a deep understanding of the customer’s needs and the STARLIMS product. The CSols consultants have experience with STARLIMS LIMS and understand laboratory processes, and therefore were a good match to provide help with the development work. To ensure project success, milestones were set at the beginning of the project. Development was completed at the end of each milestone and critical/high priority issues were addressed as needed to avoid financial impacts.
Two CSols consultants worked on the project jointly in the roles of Business Analysis, Development, Testing, and Documentation.
Benefits
Replacing the paper-based processes has improved accuracy and saved time for the lab. The client selected STARLIMS to address the needed functionality that their current LIMS was not able to provide and to automate additional lab processes. The client was able to replace several manual and paper-based processes with new STARLIMS features, such as a web portal for sample submission, eManifest to mass login samples, SDMS to integrate and automate instrument data transfer to and from LIMS, and the new Aliquoting workflow to streamline aliquoting processes.
An immediate advantage of the implementation is that it helped the lab subject matter experts evaluate their lab processes as they discussed and documented the requirements for the project. In the long term, completing the project will help the client modernize their laboratories with new technology (LIMS) to support and manage a large number of complex clinical studies.
Implementing the STARLIMS Life Sciences product will enable this client to modernize and automate additional lab processes. The CSols developers were able to deliver solutions that met the client’s requirements. The CSols developers took some of the weight off the STARLIMS project manager and the lead developers by resolving critical issues.
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