The closing phase of trial commences when the primary endpoint has been reached. This can be the same time point as last visit last patient. The following services can be provided by the CRO Diagram.
The dedicated project management team of CRO Diagram is able to perform the project management for all phases of the trial including the closing phase. During this phase the project management will coordinate that all tasks part of the closing phase will be performed e.g. close-out visits at sites, all statistical analysis will be performed and the final study report will be written and medical writing can be facilitated including preparation of PowerPoint presentations for main congressess and papers for journals can be reviewed.
Close-out is defined as the act of ensuring that all clinical trial related activities are appropriately reconciled, recorded and reported at the end of a trial in accordance with the protocol, SOPs, GCP (if applicable) and applicable regulatory requirements. A close-out is essential for the quality assurance of a clinical trial and GCP compliance and to ensure that all necessary documents are well documented for future audits. During the closing phase of a trial site close-out visits will be performed by a Clinical Trial Monitor (CTM) or Clinical Trial Associate (CRA) at each participating hospital.
Statistics and reporting
The statistical department at Diagram has an extensive experience in the analysis of data from clinical trials. The involvement of the statistical team in the start-up phase (trial design, protocol and electronic Case Report Form development, and data management) ensures a high quality for the final analyses. During the execution phase, statistical programming commences in order to ensure rapid reporting of the trial. Often the scientific interest continues beyond the initial presentation of the data.
Statistical analysis will be conducted when the primary endpoint has been reached, an interim analysis needs to be performed or to analyse the secondary endpoints including subgroup analyses. The statistical analyses will be conducted according to the predefined plan, the so-called statistical plan.
SAS and SPSS are the common used statistical progamms for analyses.
The results of the statistical analysis will be reported in a study report.
Often the scientific interest continues beyond the initial presentation of the data. Diagram can facilitate the medical writing proces in terms of:
- Presentations (input and review)
- Publications (input and review)
- Clinical study report