Clients

Our clients include top-10 global pharmaceutical companies, healthcare organizations, and software companies who support the life sciences industry with commercial software products. Our typical client needs to meet new regulatory requirements, improve existing business practices, and/or expand their capabilities.

Case Studies
The following case studies provide some examples of our work.


1. For a major pharmaceutical company

The Challenge
Manage eight projects as part of a three year, multi-million dollar program spanning the discovery through clinical trial and regulatory phases of the drug development lifecycle. Integrate various systems to comply with FDA and ICH regulatory guidelines, improve the generatation of reports in electronic and submission-ready formats for inclusion in filings such as INDs and NDAs, and provide system interfaces to eliminate manual transcription and improve data quality.

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2. For a major pharmaceutical company

The Challenge
Eliminate manual procedures for all areas of multi-site laboratory operations including test ordering, specimen tracking, laboratory instrumentation integration, reporting, and results delivery.

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3. For a leading pharmaceutical software development company

The Challenge
Improve the architecture of an established drug metabolism and pharmacokinetic (DMPK) laboratory information management system (LIMS) used by numerous pharmaceutical companies. Develop a process to import clinical study data provided by contract research organizations (CROs) into the system. Make the system fully compliant with 21 CFR Part 11.

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4. For a private equity firm that invests in IT companies serving the pharmaceutical and bio-tech industries

The Challenge
The private equity firm needs to ensure the technology, infrastructure, and technical services of the company serving the pharmaceutical industry are sound prior to making an investment in the company. The firm also needs to understand the deficiencies within a candidate company in order to inform their investment decision.

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5. For a leading pharmaceutical sales and marketing organization

The Challenge
Accurately define and estimate the scope of work, efficiently execute to plan, and manage regulatory issues for fixed price solutions constructed for major pharmaceutical and healthcare organizations.

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6. For a top ten, global pharmaceutical company

The Challenge
Enable the retirement of a Xybion Path/Tox system and associated hardware, which had been in use at several global sites for over 15 years, including archival of pathology and toxicology system data. The archived data can be utilized for subsequent FDA submission and inclusion in a non-clinical GLP data warehouse.

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7. For a top ten pharmaceutical company

The Challenge
Automate Study Report Table generation to reduce the time required to prepare report tables as well as ensure detail accuracy and format consistency.

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