Life Sciences Domain Expertise

Regulatory, Safety and Manufacturing

Bridging Data from Product Development into Manufacturing

The Situation: Traditional means of transferring a drug product from development to manufacturing along with the requisite information, involves significant formal, informal, and iterative communications. Business processes are not optimized to make the transfer straightforward. Neither development nor manufacturing systems are designed to support the transition. Information requires bi-directional translation rather than flowing in a smooth fashion. One global pharmaceutical company decided to prioritize this area, go after the problems, implement solutions, and turn deficiencies into a strategic advantage.

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Global LIMS Strategy Transformation

The Situation: 32 Laboratory Information Management Systems Worldwide! That’s what stared one global pharmaceutical company in the face, before they commenced a multi-year program to consolidate the LIMS with a more effective strategy. Six months into the implementation activities, sub-projects within the program were not on track to achieve the goals for the year and were placing the entire program and the expected returns in jeopardy. The Company engaged ResultWorks to perform a strategic program assessment and assume management of the LIMS program.

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Regulatory IT Vision and Strategy Development

The Situation: A strategic partnership with a global pharmaceutical company was the main driver for a growing CRO to revisit and develop a future IT vision and strategy for its Global Regulatory Affairs group. The partnership offered opportunities for the CRO to leverage and rationalize IT systems and business services offerings across both organizations and for other clients.

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Harmonizing Drug Safety Information Management

The Situation: After multiple mergers and acquisitions, a global pharmaceutical company was experiencing suboptimal workflow across Drug Safety. Functional areas, including Discovery PK, General Toxicology, Genetic Toxicology, Development PK and others, were operating independently without cohesive processes, systems or data models. In today’s life sciences R&D environments, however, companies are interested in leveraging studies and having access to information across portfolios. At the same time, this environment is becoming more challenging with the use of specialized partner organizations and the mandate to adhere to standards (e.g., SEND). One client found that the issues stemming from acquisitions coupled with inconsistent technical strategies across Drug Safety were hindering their ability to effectively and efficiently conduct their studies. This drove them to an initiative to develop a harmonized technical strategy that could be leveraged across the spectrum of drug safety studies.

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Designing a CMC Technology Strategy for Cell Therapy

The Situation: A biotech company specializing in cell therapy was growing rapidly with a critical need to scale its IT infrastructure to support the business. The personalized medicine immunotherapy space is delivering a relatively new therapy platform. Manufacturing processes are rapidly evolving and the process has some unique characteristics and challenges. The concept of one batch being made to order for one patient means one set of batch records for each patient and the number of batch records and data needing to be managed can multiply rapidly even during the clinical trials phase when trials of only 50 to 100 patients are being run.

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Regulatory Redesign with RIM Platform

The Situation: Increased market competition, downward price pressures, and growing complexity of worldwide regulatory reporting requirements continue to challenge large pharmaceutical companies to accelerate drug development throughput and increase right-first-time regulatory submissions, without a commensurate increase in resources. While smaller organizations may adequately meet demand using desktop tools, larger organizations require holistic, integrated platforms and streamlined business processes.

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“ResultWorks has done a really fantastic job of helping us tell a coherent story and develop a strategy around issues that we have been grappling with for years. For the first time we can communicate what is needed in a way that is understandable.”

Global IT Leader

“We met with the senior leadership team and reviewed the R&D IT strategy work. The reception was incredibly positive. Thank you for helping us shape our story – and for driving a rational approach to the program and next steps. I think folks were stunned at how much was done!”

VP R&D IT, Top Ten Pharma Company