At Stateam, we handle and simplify complex work that impacts and rewards life for our clients using cutting-edge biostatistics methodologies.Our team members are dedicated partners to internal colleagues of our clients.
We can collaborate with you in analyzing and interpreting these critical data in order to understand and improve public health.
Our approach is overall quality deliverables, within budgetand on-time.
Whether you are strengthening Chemistry Manaufacturing and Control(CMC) processes and drug ingredients stability,conducting proof of concept studies, outcomes research to embarking on clinical projects through post submission.
Are you looking at Product life cycle management, or simply accessing your data warehouse for actionable intelligence to aid in critical business decisions? Stateam is here to help.
Computing in the cloud is making it posible for analytic solution to refine large sums of health data to reach the small datasets that impact decisions.
Stateam provides Data Quality Oversight (DQO) of subject and site data through industry leading through risk-based monitoring that enable clients to proactively identify sites with issues, benchmark site performance and take corrective actions to enhance optimal clinical trials execution.
Stateam have created a suite of technologies And macros that can be used in collaboration with our clinical data managers and biostatisticians for quick data quality scans, adhoc reports, erroneous data identification, outliers identification, life cycle management and tables, graphs and listings.
At Stateam, we leverage the dynamism of SAS to carry out statistical analysis. We have a very experienced team of SAS programmers and analytic software developers.
OurSAS Programming services include the following:
- ClinicalData InterchangeStandardsConsortium(CDISC)) Programming
- CustomComputerAnalytics Software Development
- Scientific programmingto meetcomplexresearchchallenges
- And more…
We understand that one of the most important benefits of a strong healthcare quality assurance program is the opportunity to quickly identify problems that can affect patient care or safety and make immediate changes where applicable.
We pride ourselves in our efforts of achieving these in the quickest time posible; quality checks are embedded in our work processes, operating procedures and work instructions.
Ourgoal is quality deliverables with zero defects for each Project we execute.
Stateam provide expert regulatory service for our clients based on years of experience with the FDA, CLIA and the clinical laboratory. Some of the services we provide include:
- Quality Systems design and compliance
- Regulatory strategy for new product development
- Preparation of regulatory submissions to include Pre-submission, De Novo, 510(k) and PMA
- Regulatory expertise on the development of innovative regulatory strategies for client products and efforts to ensure successful regulatory submissions
- Conceptualize the scope of projects for clients from project initiation to client delivery and work collaboration with company staff, and other retained consultants and counsel
- Create both strategic and tactical recommendations for clients to ensure optimal market access for client products
- Provide analysis and strategic approaches for FDA regulated medical products including Laboratory Developed Tests (LDT), medical devices, biologics, Research Use Only (RUO) or Investigational Use Only (IOU), digital health tools including stand-alone software/mobile apps and other products regulated by the FDA
- Develop resource strategies, staff, tools and specialized support necessary for efficient client service
- Provide direction regarding pre-market regulatory policy and practices to ensure a regulatory strategy to support the client needs
- Perform pre-inspections and recommendations for meeting Quality Systems requirements
- Provide expert review and witness functions in legal cases
- Assist with preparation and review of pre-clinical, clinical and analytical studies
In order to meet your compliance objectives in a world of constant change and financial challenges requires automating, adopting advanced technologies, and leveraging outsourcing.
Stateam innovative pharmacovigilance (PV) solutions are powered by the STATEAM CORE -- integrated, scalable technologies combined with global data, advanced analytics, and deep domain expertise. Helping you predictably and cost-effectively achieve your safety and surveillance goals.
Technologies such as artificial intelligence (AI), machine learning (ML), and Natural Language Processing (NLP) are transforming today’s resource-intensive pharmacovigilance workloads, ensuring a more informed, more efficient approach.
Stay up to date with diverse regulations across global markets
Identify adverse events (AEs) and device complaints in structured and unstructured data across multiple sources
Manage case processing volumes
Easily handle high volumes and costs of multiple languages.