Learn how a biopharmaceutical customer procured the right technologies to meet their business requirements and efficiently scale operations.
At a small scale, laboratory processes like inventory and sample management, experiment documentation and management, and quality control and assurance can be executed and managed with manual paper-based processes. But as volume and complexity grow, those processes quickly become unwieldy.
Challenge
A clinical-phase biopharmaceutical company was concerned about their regulatory compliance and reporting, Intellectual Property (IP) protection, and inability to scale efficiently. They asked USDM to help them automate these processes with Electronic Lab Notebooks (ELN) and Laboratory Information Management Systems (LIMS).
Selecting lab informatics platforms is not just a software decision—it carries direct 21 CFR Part 11 and data integrity implications. Without a vendor-neutral, requirements-driven evaluation, customers risk choosing a system that fails to scale, misses critical functionality, or surfaces costly surprises after the contract is signed.
Approach
The USDM vendor selection methodology used a two-step approach—a solution strategy followed by a request for proposal (RFP)—and we applied our deep understanding of life sciences business requirements and technologies.
Solution Strategy
In the solution strategy stage, we defined business requirements and identified leading technologies to meet those requirements. This included:
- A Solution Strategy team comprised of a project manager and subject matter experts (SMEs) in quality control, manufacturing, clinical, data integrity, and cybersecurity.
- Interviews with customer stakeholders to establish use cases before formalizing business requirements. USDM maintains comprehensive business requirements to help customers identify and prioritize needs, and we integrate the unique requirements they provide.
- A summary of high-potential vendors, their relative positions in the marketplace, and their strengths and limitations.
- USDM-facilitated vendor demonstrations followed by issuing a script covering the customer’s essential business requirements and highlighting those that are important, unique, or difficult to meet.
- USDM provided fillable electronic scorecards for audience members to complete. USDM tabulated the feedback to confirm whether all vendors should advance to RFP.
Request for Proposal (RFP)
In the RFP stage, USDM compiled key information about schedules, the number of users, and professional services needs. We performed a side-by-side analysis of the RFP responses and evaluated how business requirements would be met, initial and ongoing costs, validation, release management, scheduling, and resource requirements.
USDM worked with the customer to select the vendor with the best overall fit and weighed:
- Alignment of functions and needs (from business requirements responses)
- User experience (from demonstration scorecards)
- Total Cost of Ownership (initial and ongoing costs, both external and internal)
- Ongoing vendor investment in the product
- Support
Because the selected platform would manage regulated data, USDM also accounted for downstream Computer Software Assurance (CSA) and third-party risk considerations when assessing each vendor. USDM assisted with final negotiations to ensure the best contractual outcomes and with implementation planning to ensure the project is set up for success and suitably resourced.
Results
The customer moved forward knowing that their ELN and LIMS project was correctly scoped, that they had negotiated a fair deal, and that there would be no negative surprises. With USDM’s help, the customer also determined that the project should be executed in two phases so that urgent clinical deadlines could be met by pushing some functionality to a second phase.
By grounding the decision in real business requirements, objective scorecards, and total cost of ownership, the customer turned a high-stakes technology selection into a confident, phased, and compliance-ready path to scale—protecting both their clinical timeline and their long-term operations.