Concept and design
We provide strategic insights using our experience in clinical trial management to design projects to meet the clinical trial rationale and objectives, in the most efficient and effective way. We with liaise our clients’ and third parties, including chief investigators and other medical professionals to assess the feasibility and recruitment plan. This enables us to minimise the risk of not meeting trial objectives, advice achievable targets for significant results and to agree on the right methodology and design.
Setup and approvals
We understand the individual challenges that phase 3 clinical trials present. No matter what therapy area, our experienced team can provide services and solutions to deliver larger cohorts of patients with the target condition, to demonstrate and compare safety, effectiveness and dosing, for use in regulatory approvals. Our experience and capabilities in study management drives trial progress, from inception to closeout to ensure timelines and budget are met.
Whether a trial is single or multi-centred, we work with participating sites from initial expressions of interest, feasibility, selection, costings, contracts, and site initiation visits including full training and DISTILL data entry. After initial setup we provide additional training and submit protocol amendments where required, as part of ongoing trial management.
As part of our data management offerings we translate feasibility into a data management plan. The plan will define the data points to be collected along with the methodology and process for handling, storing, and validating clinical data.
We also build electronic case report forms within DISTILL. Building the edit checks, data check specifications, conducting user acceptance testing and system validation.
As vital data are collected SVMPharma conduct remote data monitoring and verification of data, and follow up with sites to ensure timely and accurate data collection. We provide progress reports to our clients on the data collection status and quality of data being received. Working toward interim and final data locks dependent on the project plan.
During data collection we provide ongoing monitoring of serious breaches, protocol deviations and safety reporting, where applicable.
SVMPharma conduct final and/or interim data analyses, as detailed in the statistical analysis plan. We use scientifically valid methods to analyse data and ensure objectives and outcomes stated in the protocol are met.
Clinical Study Report
Upon study closure SVMPharma prepare a comprehensive clinical study report detailing the clinical trial design, methodology and results.
We can prepare abstracts, posters and manuscripts detailing trial findings and conclusions, based on interim or final data analyses, for submission to leading journals, publications and conferences.