ABOUT OUR SERVICES

Our team of highly-skilled and seasoned biostatisticians helps 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.
•  Developing protocols / planning sample size
•  Randomization
•  Statistical Analysis Plan (SAP) development
•  Planning and implementing randomization
•  Statistical consultation to clinical research and market support professionals
• Program and validate statistical Tables, Listings, Graphics (TLGs)
•  ISS/ISE database preparation
•  Data mining
•  Interim and final analysis
•  Support for regulatory affairs
•  Statistical reporting

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 the clinical development process. CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets. These standards affect several operative functions where clinical data has to be handled or is handled.
Clinotica has a very deep understanding of CDISC standards and services 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 Services
•  CDISC Mapping Specification Document
•  SDTM, ADaM Domain Datasets Generation
•  Applications Development Using CDISC Standards
•  Legacy Study Conversion
• ISS/ISE Studies Standardization
•  Comprehensive Validation of SDTM & ADaM Datasets
•  Define XML Document
•  ECTD Development & Validation  

Clinotica supports our clients from protocol writing to the final study report preparation with a highly collaborative effort across our medical writing, bio-statistics and project team members.
Our comprehensive documents are peer reviewed and undergo a stringent quality assurance to ensure medical and scientific accuracy.
•  Clinical Study Reports
•  Protocols
•  Investigators Brochures
•  CTDs/NDAs
•  Subject Narratives
•  Informed Consent Form
•  Product Monograph
•  Abstracts
•  Synopsis
•  Manuscripts
•  Journal Articles
•  Dossiers Writing(CMC/ADI)
•  Slide Presentation/Lectures
•  Conference/CME Documents