I most recently was the lead Project Manager for the implementation of a Change Management module for the QA group of one of our pharmaceutical clients. This new application was an add-on to the existing suite of Quality Management System (QMS) modules, as part of a pre-approval inspection (PAI) readiness initiative.
Posts Tagged ‘Software as a Service’
Keeping It Real: The Importance of the Conference Room Pilot
Tuesday, January 8th, 2013BioPharma IT Managers, Don’t Forget About ITIL!
Wednesday, October 31st, 2012At Maxiom Group, many of our client companies are making the transition from drug development to commercial operations. Among other things, this often involves significant growth and change in the IT group. What could once be managed on a very informal basis must now become well defined and disciplined IT processes. IT managers in this situation often experience great difficulty in creating these new and formal processes essentially from scratch. We also find that this is as true for the SaaS or hosted services as it is for the traditional on-premises environments.
Put Some SaaS in Your Clinical Trial!
Monday, July 30th, 2012In many facets of life, if you want to do something right, you feel inclined to do it yourself. This age old adage is no different for the biopharma industry, especially when it comes to developing home grown clinical software solutions. But now many biopharma companies actually employ an extensive software development team, not to mention enough IT resources and infrastructure to host and maintain the system? And with tighter resources available, is this really where a company’s talent and energy should be focused?
Commercial Launch – An Opportunity for IT Transformation
Monday, July 16th, 2012Commercial launch of a biopharma company’s first drug product is a transformative event. A first product launch includes not only preparing the organization for the transition from development to commercial, but also transforming the IT applications and support model for the company. IT organizations that have been trying to differentiate themselves or increase business presence have a unique opportunity to:
1. Modify IT’s current practices
2. Pre-plan for commercial needs
3. Support other departments, e.g. G&A, prepare for corporate transition
IT Transformation
IT organizations in small companies tend to focus on security, data centers, core applications and supporting people within the “four walls”. Commercialization and adding remote field personnel significantly challenge these current ways of doing business. IT organizations must also work to improve IT policies, enhance remote access, support new mobility devices, improving helpdesk operations and supported proposals for off-site datacenters and SaaS solutions. Organizational changes include roles and job requirements to enable IT to become partner focused.
Planning for Commercial IT
When commercial teams are hired they have already have experience launching products and typically come from more mature organizations. The new organization does not have processes, technology or people in place to support them at the rate they expect. Often, IT must develop plans and budgets prior to the commercial staff joining including the initial plans, resources and timelines for the product launch and the IT requirements necessary to support commercial efforts. As the commercial team comes on board, IT leaders should identify priorities, consult with outside experts, identify potential vendors and solutions and move quickly to execute. This approach saves time, money and keeps IT aligned with its new business partners.
Supporting Other Departments
Experience shows that cross functional support is an often forgotten aspect of commercialization. Everyone is so focused on the submission, launch and hiring a sales force etc. that little time is spent verifying if existing processes and systems are ready for the transition. New requirements and capabilities must be investigated and supported, such as:
• Aggregate Spend,
• Travel and Expense Modifications,
• Engaging with Legal to prepare for the onslaught of contracts,
• Working with Finance to change existing ERP processes and
• Supporting HR by modifying onboarding and offboarding processes.
Commercialization is a very chaotic time for a biopharma organization but IT can use it as an opportunity to change how it works and enhance its effectiveness as a business partner. This requires significant introspective assessment and engaging in a cross-functional way with the organization. However, if IT does change its business practices and focus, has initial plans and budgets ready to support new commercial management and enables other departments to actively support the changes, they can go from being just a provider of services to an active partner in commercial launch success.
Commercial launch of a biopharma company’s first drug product is a transformative event. A first product launch includes not only preparing the organization for the transition from development to commercial, but also transforming the IT applications and support model for the company. IT organizations that have been trying to differentiate themselves or increase business presence have a unique opportunity to:
1. Modify current IT practices
2. Pre-plan for commercial needs
3. Support other departments, e.g. G&A, prepare for corporate transition
ERP for Clinical Supply Chain Pays Off – A Case Study
Tuesday, March 29th, 2011About a year ago, I wrote a blog post about using an ERP system to manage the Clinical Supply Chain. Since that time I’ve had many healthy debates with different people about the pros and cons of this versus other applications that were designed specifically towards clinical operations. While I am not an expert on clinical specific apps, I do consider myself knowledgeable about ERP and how it manages supply chain transactions and data. I see far more similarities than differences between the commercial and clinical supply chain, but let’s put all the theory aside for a moment and look at a real life example.
ERP Selection: To ensure your future success – it’s all about the big picture!
Monday, November 8th, 2010At Maxiom Group we do a lot of ERP selections with our clients in the life sciences industry. Frequently these clients are concerned about specific features and capabilities, and it’s true that sometimes these details can solve, or cause, big problems. However, with ERP systems we’ve found it’s really the big picture that matters. Following are a few of the “big picture areas” we focus on when selecting and ERP system with our clients.
Is the Biopharma Enterprise Document Management market shifting? Sharepoint 2010 may now be a practical contender!
Tuesday, October 12th, 2010As you may have heard, Microsoft has released SharePoint 2010. This release has been touted to have extended features, such as enhanced governance, a more intuitive user interface and better support of the management and discovery of content.
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Get Sample Management Under Control!
Monday, September 13th, 2010Many Biotech and Pharma companies at various stages of maturity struggle with an accurate tracking mechanism for managing all of their samples. Similar to commercial and clinical inventory (management / tracking / visibility), SAMPLE VISIBILITY is also a significant issue for Life Science companies! There are several considerations, for example:
• Legal: e.g. when a patient withdraws from a study and wants their specimens withdrawn and/or destroyed.
• Regulatory: such as how long samples are to be kept in storage.
• Logistics: packaging, labeling, and shipping conditions.
• Cost: such as absorbing expensive long term storage.
Oracle Launches Major Pedigree and Serialization Product
Tuesday, August 17th, 2010Since we do a lot of pedigree-related work, and deal with many of the vendors in this space, we had an opportunity to get an early look at Oracle’s Pedigree and Serialization Manager (OPSM) solution. OPSM was designed to create and manage serial numbers, record and transmit serial number hierarchies and create pedigrees. OPSM was designed to comply with both document model (California) and centralized server (European) methods of pedigree reporting and to be extensible to meet future pedigree formats and data standards. Additionally, OPSM has an open web services architecture that should allow for additional features, such as product authentication, analytics and enhanced supply chain visibility.
Why Cloud Computing Will Penetrate Life Sciences Differently
Monday, August 9th, 2010More than half of U.S. enterprises now consider cloud computing a viable technology, with favorable views on cloud jumping by more than 50 percent in just a year, according to the Boston market research firm Yankee Group. The information technology-oriented research house said in a report that “cloud computing is on the cusp of broad enterprise adoption.”
