Saturday, November 17, 2018

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Custom vs Contract Research Organization – Which C in CRO are YOU looking for?

Contract Research Organizations (CROs) around the country and around the world serve the pre-clinical and clinical phase development of pharmaceuticals and biomedical devices. Most CROs continuously add capabilities to support large and multisite studies, and, in the current outsourcing climate, have attracted substantial venture capital and grown rapidly. Among other services, CROs provide long term, and large scale bio-analytical support, however, their rapid growth in this area seems to come with caveats. For example, the centralization of the bio-analytical services to a limited number of sites has promoted “factory” style, productivity driven, bio-analytical testing. The resulting emphasis on productivity and routine quantitative and qualitative studies predisposes the large contract analytical divisions to prefer large scale projects, especially those that come with less inherent analytical difficulty.

Mass Spec Lab is a new bioanalytical startup in Irvine, CA, launched by InVision Biomedical Group, which provides CRO preclinical and clinical build services to the ophthalmic biomedical device sector. Mass Spec Lab itself is a bio-analytical CRO, but as it grows it has carefully tried to distinguish itself as a Custom rather than Contract Research Organization. Let us explain. Mass Spec Lab formed in 2014 and launched its online presence in late 2015. The requests for analytical services have since been coming in from startups as well as large established companies, but they all have common themes. Most potential project requests to Mass Spec Lab are accompanied by the desire for:

1) fast turn-around time on sample analysis
2) timely and transparent online or in person communication about findings throughout study period
3) ability to summarize, on short notice, analytical method and topline study results tailored to customer need
4) flexibility to depart from typical quantitative or qualitative protocol on short notice to pursue identification of potentially important molecules in a data driven manner
5) ability to provide in depth sample characterization including MS based structural identification of major signals of interest.

We posit that whereas Contract Research Laboratories typically deliver on 1, 2 of the above requests, in routine projects, in addition to 1 and 2, it is the customer tailored components of 3, 4 and 5, which embody the capabilities of a Custom Research Organization like Mass Spec Lab.

Contract analytical laboratories undoubtedly do great work, and are well suited for large scale, long term, and routine quantitative and qualitative studies. On the other hand, smaller, more fleet-footed Custom research laboratories should be the first option considered in cases where the custom component of an analytical study outweighs the routine, such as untargeted analysis, unknown chemical identification (impurities, degradants and side products), studies with very tight timelines, go/no go data critical to discovery project decisions, in other words, projects requiring high levels of versatility, flexibility, and technical expertise.

Contact us for information about Mass Spec Lab’s portfolio of analytical instrumentation for your custom research need, including high resolution, accurate mass UPLC and APGC/QTof Mass Spectrometer, GC/MS, GPC and HPLC, microscopic FTIR spectroscopy, and DSC, NIST and in-house compound UV and MS libraries.

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