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LIMS Requirements Definition and Software Selection

This client is a pre-clinical Contract Research Organization (CRO) that provides studies related to drug discovery, toxicology, biodefense, and infectious diseases. Challenged by its practice operating 110,000 square feet of laboratory and support space, this CRO endeavored to implement a LIMS solution that would help manage these operations and increase the organization’s digital capabilities.

The client had been operating with mostly manual laboratory processes and had reached a state of growth and sophistication where the existing manual operations became overly burdensome. To prepare for this laboratory transformation, the client engaged Clarkston to define their LIMS requirements and execute LIMS software selection. The organization initially attempted to perform a LIMS selection themselves, but quickly realized that the complexity of the selection process and long-term impact of the decision warranted assistance from a consulting partner with LIMS vendor selection experience. In addition to leveraging Clarkston’s specific LIMS expertise, additional benefits for the client included efficiencies gained from using Clarkston’s structured vendor selection process (optimized scoping, time and budget management, established roles and deliverables, etc.).

Download the Full LIMS Requirements Definition Case Study

The primary objectives for the LIMS requirements definition project team included assessing laboratories, plans, processes, and pressures by conducting stakeholder interviews with a focus on the client’s area of study. The objectives included documenting findings, developing detailed user requirements, and confirming and finalizing user requirements with key stakeholders. The team developed an RFP and performed a final review, among other project tasks.

This resulted in confirmation and finalization of the CRO focused user requirements with client stakeholders, issuing an approved RFP to prospective LIMS vendors, evaluation of prospective LIMS vendors, and Confirmed and finalized CRO focused user requirements with client stakeholders, and the evaluation of vendor demos to achieve objective final LIMS provider selection for the company.

Download the full LIMS Requirements Definition Case Study here

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Tags: Case Study, Quality and Compliance Technology, Quality Operations, LIMS