Experienced Biostatisticians can provide expert opinion and help you make critical inferences and decisions from your clinical trial processes. As demand for CDISC compliance and standardization grows, how you leverage biostatistics and SAS programming could significantly influence your competitive standing in the marketplace.
A plethora of technologies and the ever-increasing complexity, volume, regulatory requirements, and geographic spread of clinical trials is forcing companies to examine their core focus areas, while encouraging them to outsource clinical data management, SAS programming and biostatistics to a trusted partner.
How Navitas Can Help?
With the primary focus of a pharmaceutical/biopharmaceutical company or a CRO being science and research, they need a versatile technology organization with clinical research expertise to take care of all their data management, clinical programming and IT needs without incurring additional fixed costs. They also look for supporting partners who need to be responsive and can ramp up and down to meet the peaks and valleys of work load, at a reasonable cost while ensuring high quality working in regulated environments.
Navitas provides biostatistics and statistical programming services such as randomization, sample size calculation, input to protocol, statistical analysis plan (SAP) drafting and generating efficacy reports.
The programming team is responsible for TLF (tables, listings and figures) generation, data pooling, to ADaM dataset creations. Navitas provides flexible and scalable engagement models to manage your Biostatistics and SAS Programming outsourcing needs. These models assure quality services, constant communication, and improved efficiencies.
Navitas has a wide range of expertise in all phases of clinical trials (I-IV), with all its statistical programmers holding advanced degrees and having a strong exposure to various therapeutic areas. We work with the end goal in mind, which is the timely submission of results from various clinical stages in order to support regulatory review, approval and monitoring of patient safety.
- Standardized approach for analysis files
- Transportable tools to support standard non-efficacy reports
- Programming based on analysis data Independent quality reviews
- Customized clinical data outputs Proactive, results-oriented approach to programming
- Programming for integrated summary of safety and efficacy
- Adoption of sponsor’s programming (SOP) Preparation of Case Report Tabulations (CRT) for submission
- Programming based on data validation plan
- Programming of tables/listings/figures for clinical study report and data monitoring committee
- Off shore or onshore models, including FSP (Functional Service Provider)