(Bio)statistics and Medical Writing

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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!

Our services:

Sample size

Defining the right statistical approach, followed by the sample size estimation, saving time and reducing costs in clinical trials.


Statistical analysis plan development.


Statistical analysis of results in clinical studies of all phases. Interim reports, pre-clinical and clinical summaries and reports. Meta analyses and statistical consulting.


Clinical study design and study protocol development for phase I-IV studies.

Document development

Investigators Brochure development, CRFs, clinical study report production, ICH E3 compliant.

Manuscript development

Manuscript and journal article development, including posters and PowerPoint presentations.

Other documentation

SmPC, PIL and mock-up preparation for drugs and medical products.


CRF logging and tracking, data acquisition in paper, electronic and optical character recognition scanning forms.

AEs / SAEs

SAE reconciliation, medical coding of adverse events (MedDRA, WHO-ART, COSTART) and of concomitant medications (WHODRUG and BNF).