Arik Gorban | Capgemini
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
Ed Price | PCI Synthesis
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 A challenge of enforcing quality SOPs is that information can become quickly outdated because of constantly updated FDA regulations.
Continue reading "Three Questions to Ask Your CMO about Standard Operating Procedures"
Topic of Discussion
Laurie Halloran, BSN, MS | Halloran Consulting Group
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.
Continue reading "Life Science Management Consultants: Looking at the Right Stuff"
East Norriton, Penn. Feb. 4, 2016. TGaS® Advisors is expanding its roster of commercial solutions with the addition of Medical Regulatory Legal (MRL) Operations. The new solution reflects high client demand in this critical area. The benchmarking and advisory firm also named TGaS Management Advisor Karl Kraft to head the new practice. The MRL benchmark is in growing demand as companies seek to make this critical process shorter, more efficient, more strategic and less costly, according to ... [Continue Reading]