(Bio)statistics and Medical Writing
Following our philosophy of one stop solution, Clinres Nova provides a whole range of services in statistics for clinical trials and other types of research, followed by preparation of manuscripts for peer-reviewed journals.
In planning a clinical trial of any phase, statistical consulting is one of pivotal elements in the process. Immediately after study end points are defined, and well before sample size calculation is performed, a right statistical approach to study results should be defined.
For the new laboratory test, is between-group comparison enough, or does the ROC curve need to be used? In a clinical setting, do all the variables available should be used or can the number of dimensions be reduced? In defining risk factors and survival, how to choose the right approach to regression analysis?
Knowing the answer to such questions can significantly reduce planning time and cost of the trial. When the statistical model is defined, a sample size can be calculated, and later phases of study development may bagin. We provide all services necessary, including randomisation schedule in a centralised, telephone, web, paper or envelope form, statistical analysis plan (SAP) development, statistical consulting, study report writing and meta analyses with previous studies.
Medical Writing
In Clinres Nova, we believe in a work-finish-publish approach to clinical trials and research.
Over the course of a clinical study, a number of documents is needed to define endpoints, collect data and clearly and concisely present results. We can work with or for your company to develop a study protocol, write, design and distribute Investigator's brochure and design and print or publish electronically a CRF.
During the study, we can produce interim analyses as foreseen by the study protocol, thus pointing to possible problems in study design while they can still be addressed. After the work is done and all analyses performed, a well written document, compliant to all relevant standards is needed in order to communicate your finding to the industry or the scientific community.
With such approach, utilising our knowledge and experience, we can follow your study from idea to publication!