Biomarker clinical studies Navigating the maze of regulations and requirements in planning a new clinical study can be daunting.  However, all of our clinical project managers are trained in the implementation of good clinical practice (GCP), and in complying with the EU Clinical Trials Directive (2001/20/EC), which means that we make sure that the study you require is turned from the initial stages of planning into reality with the minimum of inconvenience on your part.  There are a number of factors that make biomarker clinical studies different from other clinical studies, and our expertise is in ensuring that they are fit for purpose. Often sample preparation is a much more critical part of the process than with other clinical studies, although this will depend upon the aim of your biomarker programme.

Biomarker clinical studies are often carried out as add-ons to other studies. In these circumstances, we are happy to help you with any or all of the work required for your project. It is possible, for example, for us to provide the expertise to help build an add-on to an existing clinical study so that the biomarker part of the study is a success. Whether you would like help just with the design of the study, or some or all of the execution phase, Total Scientific has the expertise to help. Regardless of the type of study being carried out, throughout the process your dedicated project manager is critically appraising the protocol to ensure that the biomarker part of the study is as robust and efficient as possible.   

One crucial aspect of all clinical studies is the data management. We have ten years experience in developing and distributing custom FileMaker database as electronic case report forms. So, your clinical team can enter data directly into the electronic database using laptop computers or for more portability can use smartphones or touchscreen tablet computers. Linked directly back to a FileMaker server using Wi-fi or 3G networks, multiple users at multiple sites can be simultaneously entering data with ease. See here for more details of our data management services.

Total Scientific also has access to a wide range of existing sample collections. It may be that your biomarker discovery needs can be met from existing resources, saving time and cost. Contact us now to discuss the possibilities. 

In addition to clinical studies designed purely around biomarker identification or validation, we are able to carry out other atypical clinical studies as well. Our small size, and internal flexibility mean that it can be cheaper for you to work with a CRO that is used to carrying out bespoke studies, rather than paying over-the-odds with a traditional CRO when asking them to run less typical studies that do not fit their usual pigeon-holes.