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Paul Kocak

Guide to Pharmaceutical Software

Manage research and new product development with pharmaceutical software


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Pharmaceutical software companies provide bioinformatics, the fertile ground of new product development in a rapidly evolving and highly competitive field. More than most other industries, pharmaceutical manufacturers depend on a close collaboration of academic researchers, scientists, distributors and allied institutions. Pharmaceutical software taps the wellspring of available information and methodologies as well as untested experimental initiatives.

Software for pharmaceutical manufacturers facilitates product development in a highly regulated environment where database management and accurate record keeping are essential. By using customized pharma software that assists drug developers, R&D departments manage complex laboratory analytical data that applies toward new products. Tailored modeling components enable users to import or export data as needed. Before ordering software for pharma applications, consider the following:

1. Does the drug testing software support the platform your staff is already using? In other words, is there a steep learning curve for users?

2. Is the drug information software compatible with other software tools you are using now or anticipate using?

3. What technical support does the pharma software firm offer to help customize applications for your objectives?


Action Steps
The best contacts and resources to help you get it done

Participate in webinars or tutorials or read case studies from pharmaceutical software companies


To navigate through the thicket of countless alternatives of software for pharma, familiarize yourself with the available bells and whistles. A good starting point is a discussion forum, webinar, tutorial, case study or newsletter.

I recommend: Golden Helix has online tutorials and webinars for drug discovery software, with staff support and training available. A directory of nearly 200 firms at ChemIndustry enables you to browse through hundreds of offerings of drug discovery software and other software for pharmaceutical applications.

Make sure your drug software facilitates compliance with regulatory mandates


The FDA's traceability requirements are an important part of any pharmaceutical R&D program. With bioassay software that allows replication of chemical configuration and analytical processes, FDA compliance is easier.

I recommend: SAS features a robust array of drug software, with built-in components to foster FDA compliance. To make compliance with the FDA's 21 CFR Part 11 rule, CambridgeSoft has e-notebooks that automate for chemical process and FDA compliance.

Attend user meetings or events to learn directly from drug information software producers and peers


Conferences, trade shows and meetings of user groups introduce you to the leading edge of pharma software development. This establishes relationships with vendors to make it easier to customize solutions for your firm.

I recommend: CambridgeSoft sponsors events worldwide with opportunities for product knowledge updates and networking. The annual INTERPHEX conference assembles pharmaceutical leaders, including pharma software developers, from around the world.

Tips & Tactics
Helpful advice for making the most of this Guide

  • At the outset draw up a matrix of the attributes you want in your drug software, then use that as a checklist against products you review.

The official source of Pharmaceutical Software is
the Pharmaceutical Software page at Business.com

Featured Vendors

Operational Risk Management Solutions & Software
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www.syntexsolutions.com

Pharmaceutical Industry Solutions from AT&T Wireless
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att.com/builtforbusiness

Pharmaceuticals Lifecycle Management Software
Provides software for planning, design, construction, and operations of facilities. Manage real-time change, cost reporting, and global collaboration.
www.skire.com

Pharmaceutical Software Consulting
Claricode develops custom software for prestigious pharmaceutical and healthcare organizations. Based near Boston in Waltham, Massachusetts.
www.claricode.com

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