Biotechnology information systems must secure valuable intellectual property, especially when working in the cloud.  A highly regulated industry, firms must comply with the FDA, the Leahy-Smith America Invents Act (AIA), the Export Administration Regulations (EAR), the Office of Foreign Assets Control (OFAC) and the International Traffic in Arms Regulations (ITAR). Biotech research is funded primarily by venture capital firms driving Initial Public Offerings (IPO) and merger consolidations in the market.  With an ever increasing use of digital and Internet-based alternatives in operations, biotechnology information systems must be designed to future-proof the business.

“Lighthouse Information Systems helped us save two years and millions of dollars by ensuring our documentation was FDA validated in a single inspection.”

 

Case StudyBiotech Firm Faces Unique Challenges

Situation:

During clinical trials, a biotech firm was required by the FDA to validate the documentation of their processes. There was petabytes of data to sift through. Without the right technology, it might have taken the client years to meet this regulatory requirement – causing long delays in development and costing millions.

Approach:

Lighthouse teamed with executive management to:

  • Establish standards and practices for IT

  • Align technology infrastructure with regulatory requirements

  • Ensure technology support of the clinical trial process

Key to Success:

By first observing company processes and developing an understanding of our business model, Lighthouse tailored technology to their operation. They also built in standards, practices, and disciplines into company applications. This helped the client anticipate the demands of an FDA audit and keep clinical trials on schedule.

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