SAS is the standard statistical package used across the clinical trial industry. It is an extremely complex system whose installations, upgrade, patches and performance management calls for expertise. Each of these changes will have to follow the Computer System Validation and Change Management SOPS and all will have to be audit trailed. IQ/OQ for the SAS software needs to be performed with every upgrade. For pharmaceutical companies, this poses a major challenge, and that’s where we can help. Vita Data Sciences is a Silver SAS®Alliance Partner. Our partnering with SAS® ensures that our clients in the life science industry receives benefit for a safe and effective way of launching noble drugs, medical devices and effective treatment ways.
SAS® System Implementation
In partnership with our trusted IT vendors, VDS will be able to help your company set-up and manage a validated regulatory compliant environment to securely store your clinical data and meet your needs to perform statistical analysis and reporting. We will also help you with identifying the optimal hardware and software configuration.
- Install, qualify and validate your SAS® environment
- Provide senior level SAS® system qualification support
- Qualified hardware and software configurations
- Appropriate Network configurations
- PQ/IQ documentation
- Audit Support
TIBCO Spotfire® System Implementation
A strong Data Analytics team who offers an “out-of-the-box” solution for data review and visualization using the TIBCO Spotfire® tool.Our Spotfire developers offer a suite of consulting services such as Dashboard development, installation & upgrades, Spotfire SDK expertise, architecture services, and best practices.
- Deliver data in visual, geo and streaming analytical form
- Build standard dashboard and data visualization templates
- Customized solution in Spotfire based on user requirement
- Supplement data review, visualization and analytics
- Enable ongoing clinical data review and safety monitoring
- Contribute to study CSR and Clinical Safety and Efficacy
- Results in an accelerated NDA
The VDS “out-of-the-box” data analytics and visualization solution using industry standard tools like Spotfire®, Tableau®, QlikView® etc. provide our clients with real time trial dashboards on all the ongoing trials. This will enable the client to better manage and monitor the trial from Day 1. Our reports are aesthetically appealing and provides drill down capabilities which will enable a trial monitor to gather specific data points that are looking for. We also provide development services that enable ad hoc reporting as the trial progresses which enables the sponsor to generate data points as and when they need it.
Clinical Data Review
VDS offers clinical data solutions which will speed up the review process while ensuring adherence to protocol, identifying compliance issues and implementing corrective actions. Our advanced analytic solutions help clients to overcome reviewing issues and concerns. Our clinical development team quickly prepare and analyze data to unveil insights that will help the sponsor in making informed decisions on the safety, efficacy and medical outcomes.Data quality issues can be identified and rectified during the course of the study through these systems.
Massive volumes of data collected across the clinical trials provide an opportunity for the pharmaceuticals sector to improve their drug development strategies like clinical trial design, patient recruitment, site performance, resource allocation and Trial monitoring an overall decision making. VDS leverage the power of operational analytics using real time data from all phases of clinical development to provide interactive visualization, determine performance gaps, deliver operational in-sights that ultimately enhance the overall trial performance of the sponsor.
Risk Based Monitoring
Sponsors are facing major challenges in the complex task of monitoring the progress of geographically distributed trials. VDS RBM solutions are driven by a dynamically configurable rule engine. It helps sponsors and CROs to adopt an agile risk-based monitoring approach throughout a trial. Our RBM framework provides the user with the capabilities to define key performance indicators related to the trial. It also helps the sponsors to assimilate data from the various data sources which will be warehoused and analysed in order to provide actionable insights on the ongoing trials.
Vita Data Sciences, a division of Softworld Inc.
281 Winter Street, Suite 100
Waltham, MA 02451