CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities. After being recommended by FDA, this data standard has been implemented by clinical research organizations, contract research organizations, Pharma/biotechnology companies, and other companies which use or generate clinical data. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation.
CDISC standards have a direct and strong impact on pharmaceutical industry and between the industry and regulatory authorities. Aktrix has a very deep understanding of CDISC standards and believes these help in achieving the miracles in driving the Clinical Research process. Hence provides a number of services on the lines of CDISC.
OUR CLINICAL SERVICES
Our team of highly-skilled and seasoned biostatisticians help you in creating an impeccable study design and supports you in the complete study. We provide the complete range of Biostatistics support for the clinical trials.
- CDISC Mapping Specification Document.
- SDTM, ADaM Domain Datasets Generation.
- Applications Development Using CDISC Standards
- Comprehensive Validation of SDTM & ADaM Datasets
- Define XML Document.
- eCTD Development & Validation
- Statistical Analysis Plan (SAP) development
- Support for regulatory affairs
- Program and validate statistical Tables, Listings, Graphics (TLGs)
REGULATORY AND CLINICAL WRITING
Our team of professionals help our clients in the following areas:
- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure.
- Study Protocols.
- Clinical and Non-Clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US regulatory Authorities.
- Investigator Brochures.
- Patient Safety Narratives.
- Patient Information including Informed Consent and Patient Brochures.
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