Medical Communications

Protocol Development

Syreon can provide comprehensive protocol development services for all phases of clinical research in accordance with ICH standards. Protocols may be developed in their entirety from the stage of an initial concept, incorporating objectives, hypotheses, study design, inclusion exclusion criteria and detailed instructions for all study visits and procedures, in addition to standardized sections on safety reporting, protection of subjects and confidentiality. Alternatively, Syreon can provide medical review and editing of protocols which are already provided in draft stage by the Sponsor.

Clinical Study Reports

Syreon will develop comprehensive interim and final clinical study reports in accordance with its standard internal templates written in accordance with ICH guidelines. Final reports are normally completed within the industry standard 28 days of database lock pending review and sign off by the Sponsor.

Scientific Analysis and Publication of Data

Syreon employs a standard process to determine priorities for data analysis, to ensure quality, consistency, and scientific validity of publications and presentations, to distribute the responsibility for presentation fairly among scientific advisory board members, and to inform participating sites of all publications and presentations.

Study data may be used for the purposes of improving clinical care, directing research efforts, focussing marketing activity, streamlining formulary acceptance and funding, and refining long-range planning by the study sponsor. Depending on the design, the study data may:

>  Provide accurate information on the population use and benefit of a specific therapy.

>  Enable the rapid introduction and use of therapy according to evidence-based best practices.

>  Simplify negotiation of contracts or warranty programs based on demonstrated effectiveness.

>  Illuminate emerging critical research questions within an established digital research network.

>  Facilitate continuous post-marketing physician support to ensure optimal use of therapy.

>  Provide an important marketing tool for ongoing research in a rapidly evolving field.

>  Enhance clinical vigilance by continuous monitoring of treatment and outcomes.

>  Foster authoritative presentation and publication at the highest scientific level.

Continuous Reporting

Irrespective of the mode of data capture (EDC or paper), all studies are designed to accrue and process data real time. Syreon can therefore provide continuous and cumulative reporting for a range of parameters ranging from study metrics to principal explanatory variables and outcomes. These results can be reported on-line within the study web site for EDC studies. Access is restricted to selected Sponsor designates and approved scientific or safety review experts through password authorization.

Abstracts, Presentations and Manuscripts

An expert editorial team develops the text and format for slide presentation or manuscript submission, and coordinates review and amendment by investigators and other study participants, enabling the results of the study to be presented and published for peer review without delay.