Overview

Increased biopharmaceutical R&D outsourcing, exponentially growing data volumes, and new technologies have led to a growing complexity in laboratory workflows. At the same time, laboratories are being asked to reduce costs and increase quality, compliance, and efficiency. This challenging work environment has made highly functional Laboratory Information Management Systems (LIMS) an operational necessity.

In this case Astrix supported a leading global pharmaceutical, biopharmaceutical, and medical device contract research organization (CRO) in a major effort to select a commercial LIMS system that would meet their requirements. The customer has a broad and integrated portfolio of laboratory and manufacturing services serving biopharmaceutical companies – from discovery to commercialization. A critical requirement for the new LIMS solution was that it was flexible enough to support a broad portfolio across multiple laboratory environments.

The customer’s laboratory operations were largely manual and paper-based, and they had been informed by a number of study sponsors that they needed to start using a LIMS or they would lose business. Due to the fact that both their professional reputation and business were on the

line, the customer set an aggressive timetable of one year for a LIMS implementation project. With this kind of accelerated schedule, the customer could only afford a couple of months to devote to the LIMS selection process and could not afford to make a selection mistake. Impending sponsor audits forced an aggressive project schedule in a high-pressure environment.

The customer assembled a team comprised of a Project Manager and Business Analysts to collect user requirements, develop process flows, and assemble project documentation for the LIMS implementation. Recognizing the need to enlist the services of an organization with knowledge of the industry and experience implementing LIMS in large, scientific organizations, the customer interviewed several LIMS consultants. Due to an extensive track record of success in both LIMS selection and implementation projects, Astrix was selected to provide the LIMS evaluation and selection services.

Services Provided:

To ensure a successful LIMS evaluation and selection process that would meet the needs of the customer, Astrix applied a best practices methodology that included the following tasks

• Requirements Review and Recommendations

• Develop LIMS Vendor List

• Request For Proposal (RFP) Preparation

• Vendor Evaluation and Short List

• Demonstration Guidance, Vendor Demonstrations, and Vendor Selection

• Contract Negotiations

Requirements Review and Recommendations:

Utilizing the Astrix proprietary Laboratory Requirements Database™, Astrix reviewed the requirements provided by the customer’s team to ensure they were both complete and properly categorized and prioritized. The Laboratory Requirements Database™ contains requirements from all past projects, organized by industry and various project categories. Astrix searched this database to create a customized requirements template for the customer, which was then compared to the requirements provided by the customer. Based on this comparison, Astrix made a number of recommendations and the project requirements were finalized by the customer.

Deliverable: Requirements Recommendation Report

Develop LIMS Vendor List:

After reviewing the finalized requirements and project budget, Astrix developed a customized list of vendors for consideration utilizing the Astrix Vendor Database™ – a proprietary database of vendors offering solutions to the analytical laboratory community. This list contained the recommended LIMS solutions, along with the rationale for each selection.

Deliverable: LIMS Vendor List

Request For Proposal (RFP) Preparation:

Working closely with the customer’s procurement group, Astrix helped the customer develop the RFP, which was then sent to all the vendors on the LIMS Vendor List. Astrix was available to respond to vendor questions regarding the RFP. To prepare the customer for evaluation of the incoming proposals, Astrix developed a LIMS Evaluation and Selection Plan – a formalization of the evaluation process tailored to the customer’s specific needs and procurement policies. In addition, Astrix developed a Proposal Score Sheet based on the structure of the RFP that the customer used to evaluate each vendor proposal, along with a scoring database to streamline calculation of scores by reviewer and scores by vendor. A Proposal Score Sheet Guidance document was also delivered to assist the reviewers in understanding the methodology and point scale of the scoring process.

Deliverables:

• LIMS RFP
• LIMS Evaluation and Selection Plan
• RFP Proposal Score Sheet
• RFP Proposal Scoring Guidance document for review team

Vendor Evaluation and Short List

Astrix reviewed and scored each vendor proposal (as a non-voting member of the Evaluation Team), and then compiled all the proposal scores from the review team into the Scoring Database. After evaluating the data in the Scoring Database, Astrix made recommendations regarding the most suitable vendors, based on a number of factors:

• Technical considerations
• Technical considerations
• Business considerations
• Functional considerations
• Project Experience
• Estimated project cost
• Estimated project schedule

Taking into account Astrix’s recommendations, the customer choose a short list of vendors, which were subsequently invited to demonstrate their product to the Evaluation Team.

Deliverables:

• Review and information-only scores from Astrix for each proposal
• Compiled RFP proposal scores from review team in an Evaluation Database
• Vendor shortlist for demonstrations

Demonstration Guidance, Vendor Demonstrations, and Vendor Selection

Prior to product demonstrations, Astrix provided each vendor on the shortlist with customized demonstration guidance documents (demonstration scripts) that required vendors to demonstrate features of key importance to the customer. This guidance document directed each vendor to provide the same specific information in a specific order during the course of the demonstration period, ensuring that the strengths and weaknesses of each system were apparent to the Evaluation Team. This methodology avoids the possibility of vendors demonstrating only those features they feel are strong during the demonstration, and thereby limiting the ability of the Evaluation Team to determine whether the system is a good fit for their needs. Astrix developed a score card base on the demonstration guidance, and each of the vendor demonstrations were scored with the results being added to the proposal scoring outcome to determine the final score for each vendor. Astrix then coordinated review meetings where the findings were reviewed, and a LIMS vendor was selected

Deliverables:

• Demonstration Guidance to Vendors
• Demonstration Score Sheets
• Demonstration Scoring Guidance document for review team
• Compiled Demonstration scores from review team in a Scoring Database

Contract Negotiation

Astrix assisted the customer in negotiating a contract with the selected LIMS vendor to ensure the contract included the scope, budget, and assurances required (feasible implementation schedule) for the vendor to successfully implement the LIMS. Once the contract was approved, Astrix coordinated vendor debrief meetings, which allowed the LIMS vendors that submitted proposals to receive feedback regarding their proposal from the customer review team.

Deliverables:

• Assistance in negotiating LIMS contract
• Payment Milestone Schedule for inclusion in LIMS contract

Results Delivered:

Astrix delivered all the services listed above within a three month timeframe. The customer was very pleased with both the services they received from Astrix and ultimately the performance of the LIMS they selected. In the end, the CRO was able to complete an accelerated LIMS selection and evaluation process with assistance from the Astrix team. In addition, having outside resources to guide the process freed up critical internal resources to support key on-going activities, including sponsor.