Paradigm Shift – Project-based Engagement to SLA/Capacity-based Compliance Outsourcing


Life science companies are still struggling to find the right balance in managing IT compliance, quality and cost. They must meet compliance requirements for multiple regulations, while at the same time are under significant pressure to cut costs, reduce permanent staff, and outsource activities that are not part of their core business. Compliance costs are considered a significant overhead, especially when not done effectively. To optimize these costs while increasing work quality, firms are moving away from project-based engagements to service level agreement (SLA)/capacity-based models.
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In The Headlines

Three Questions to Ask Your CMO about Standard Operating Procedures


Developing and implementing standard operating procedures (SOPs) are an important part of drug development and manufacturing. Done correctly, SOPs provide consistency and ensure that procedures meet FDA standards. Done poorly, they can be unclear, leading to errors and inconsistencies and focus on the how but not the why.  A challenge of enforcing quality SOPs is that information can become quickly outdated because of constantly updated FDA regulations.
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Topic of Discussion

Life Science Management Consultants: Looking at the Right Stuff


Envision your contract research organization’s (CRO) team has significantly underestimated the complexity of a large pivotal program in a breakthrough medical treatment for your client, a major medical device company. You, your team, and the entire company are under immense pressure from the FDA because of safety concerns, which have escalated to an excruciating level of tension. You may find your tension level rising just reading this. For many organizations, this scenario is all too familiar, as regulatory and compliance regulations increase.
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