George Clinical provides analysis and medical writing services for both investigator initiated and industry sponsored trials.
We have the capabilities to provide the following comprehensive medical writing services:
George Clinical provides sponsors with extensive experience in the development of protocol for every phase in a global working environment. We know first-hand how patient care is delivered and how research integrates into clinical practice to provide sponsors with protocol designs that work at the site level, while still addressing the needs from a scientific perspective.
Our extensive therapeutic experience allows us to craft protocols for the most complex early phase I programs, all the way through the open label observational research programs in the post-approval environment.
George Clinical has the ability to obtain leading principal investigator feedback where it matters (i.e. how to overcome potential barriers) and apply this to information to the protocol development process. We utilize a classic format of “potential challenges” and “workable solutions” to go over in great detail each element of the protocol for our clients. From the scientific side, sponsors benefit from our extensive knowledge of research design and statistics. George Clinical has extensive experience in statistical methodology, adaptive analysis, and statistical models.
Study Reports for Phases I-IV
Clinical Study Reports developed by George Clinical are created through a collaboration between published scientific experts and medical writers experienced in the nuances of regulatory requirements and scientific publishing. Sponsors benefit from this added expertise. George Clinical authors know what crucial information editors require for publication and feature clear, concise writing accompanied by extensive tables of readily understandable, and relevant information. Abbreviated study reports are also available. Well-constructed Study Reports facilitate a smooth transition to publication, serving as the source documents for future manuscripts, book chapters, and presentations.
George Clinical provides sponsors with expertise that extends from statistical thought leaders through to in-practice clinical research experience and meta-analysis of results by PhD level researchers. The result is relevant information that meets the most stringent review by regulators and the scientific community and the opportunity to develop and analyse future research questions. Augmenting the data itself are visual representations of the material that provide lay-observers with an immediate understanding of the material.