SME Data Tech provides biostatistics & statistical programming services to its clients in the entire clinical development cycle – protocol development, study design, statistical analysis, and regulatory submission.
Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.
SME Data Tech is a CDISC Gold member. Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater efficiency.
Healthcare industry has made significant progress in the last decade due to advances in computing technologies and cloud digitalization. The ability to gather real world evidence and analyze this data has changed the world of healthcare.
SME Data Tech, a healthcare analytics company provides technology services with a focus of adding value to customers in an industry with evolving standards and periodic changes in the regulated environment. We operate in a world with evolving customer needs to meet changes in customer specific requirements.
Capturing quality clinical trial data is the key to ensuring patient safety and confirming efficacy in clinical development today.
We provide data management services from study start-up to database lock within mutually agreed timelines, also ensuring data quality and integrity. Our CDM team guided by standard procedures, will analyze the data collection requirements from clients, implement different effective strategies, and thereby provides the best solution in a quick, reliable, and cost-effective manner. The team has rich experience in handling various industry benchmark EDC tools such as Inform, RAVE and Veeva tools to design and review Case Report Form (CRF), visualization and reporting tools such Spotfire and J-Review.
Our expertise sways beyond traditional CDM services and our capabilities include risk-based monitoring, medical coding and automation across therapeutic areas including vaccines and experience in managing various phases of a clinical trial.
Our project management capabilities have been our strength with risk management experience, robust communication framework, enhanced data security and business continuity readiness, people friendly culture all leading to achieve our goal of exceeding customer expectations.
SME Data Tech Solutions Inc
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