Statistical Consultancy for biotech and pharmaceutical companies comes in many shapes and sizes. Having the right level of support for the right project is vital, and the demand for on-hand, flexible support at a moment’s notice is increasing. Last week in our 4 part Statistical Consultancy Speed Dial series, we looked at Trial Design. This week, we’re discussing when a company might require CRO oversight.

Biopharma companies who have decided to outsource all their clinical project management activity, but don’t have an in-house statistical group, will still need to perform oversight of the statistical and programming deliverables such as Statistical Analysis Plans, dataset specifications and outputs to meet their obligations as sponsors.

Having a Statistician on hand to perform the review ensures not only the statistical robustness of study documentation, it also reinforces a high standard of work. Having an experienced, high quality Statistician to provide CRO support also provides a different perspective than what might be available from in-house, non-statistical personnel. This is absolutely vital and can be a major factor when it comes to ensuring on-time, accurate deliverables. 

Here are Veramed, we can provide such support at a moment’s notice. We’ve supported clients with high quality statistical oversight for both big and small projects around the world with a proven record for maintaining quality, as well as increasing efficiency and on-time delivery.

A great example of how we’ve supported companies with CRO oversight can be found through one of our consultant Statisticians, who works with a small biotech client. In this particular instance, the client had outsourced the entirety of its study’s statistics and reporting. We provided a Veramed Statistician and a Veramed Programmer who reviewed draft SDTM and ADaMs datasets and outputs for an early dry-run. There were a number of quality issues picked up at this review by the Veramed team and they were able to provide clear feedback to the vendor so that this could be resolved quickly and off the critical reporting path.

As increasingly tight margins and deadlines face the bio-pharma industry, the need to receive the right statistical support and the right time is vital. CRO Oversight is just one way to help ensure your study gets the support it needs. Stay tuned for option three in our Statistical Consultancy Speed Dial series, which looks at regulatory support.

Get in touch to learn more about our flexible and collaborative Statistical Consultancy services.

 

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