Clinical Data Management. Medical Writing. Bio-Statistics & Programming

Transcription

1 Clinical Data Management Medical Writing Bio-Statistics & Programming

2 About Us Clinnex is a Quality focused ICH/GCP compliant Clinical Research Organization (CRO) with focus on providing high quality Biometrics services (Clinical Data Management, Statistics, and Medical Writing services) in accordance with global regulatory standards to Bio-Pharmaceutical companies, Contract Research Organizations (CRO) etc. Our Biometrics services (Clinical Data Management, Statistics, and Medical Writing) and systems are tailored to cater to the various clinical trial needs of our customers, from individual stand-alone services (i.e. only DE or coding etc.) to outsourcing of end-to-end studies, and are governed by well defined SOPs which are compliant with regulatory requirements. Our standard processes are derived from the Good Clinical Data Management Processes (GCDMP) as defined by the Society of Clinical Data Management (SCDM). The services offered by Clinnex include : Clinical Data Management Statistical Analysis and Programming Medical Writing Consulting

3 Clinical Data Management Our aim is to provide high-quality data management by ensuring that the data are complete, reliable, and processed correctly. The clinical data management group is involved in all aspects of the clinical trial process, from development of the protocol till report writing. At Clinnex, we have implemented industry recognized and accepted data management systems (Oracle Clintrial / Filemaker Pro and for EDC we partner with various vendors to provide EDC services) which enable us to deliver high-quality outputs with confidence. To ensure integrity and validity, we implement quality assurance and quality control measures. Statistical Analysis & Programming The Statistical Analysis and Programming group has been involved in the analysis of data from all stages of clinical development with a variety of designs and statistical hypotheses including interim analyses using adaptive, sequential, and sample size adjustment designs. We strive to provide you quality services across a wide range of therapeutic areas and all phases of clinical research. The DM team has extensive data management experience across a broad range of therapeutic areas, using both paper and EDC systems. Our Mission is to be acknowledged as a high quality Biometrics services provider and a preferred partner to our Clients by managing and accelerating biometrics deliverables more effectively to meet their business goals. Our Data Management Services Include: Our Statistical Analysis and Programming Services Include : Case Report Forms designing and completion guidelines Data Management Documents (i.e. DMP, ECP, DEG, SEC etc) Database design Tracking, Entry, and Verification Discrepancy identification and management Medical coding Integration and verification of external data Serious adverse event (SAE) reconciliation Protocol violations Data mapping (CDISC) Quality control (QC) Accelerated database lock Final archiving and imaging Sample Size Calculation Study Design TFL Programming Statistical Analysis Plan (SAP) Randomization (Paper and Electronic) Statistical Analysis Statistical Report

4 Medical Writing Clinnex Medical Writing group understands the need for fully integrated clinical study reports fulfilling all global regulatory and ICH-GCP requirements, incorporating all investigator and client requirements, including present e-ctd requirements. Our Medical Writing team is capable of producing clinical study reports within tight timelines, whilst ensuring well documented QC and review processes. We ensure appropriate interpretation of quantitative results. We provide support to the project team for preparing abstracts and posters and manuscripts. Our Medical Writing Services Include : Protocol Clinical Study Report Poster Abstract ISE / ISS Clinnex provides consulting and resourcing solutions related to Biometrics services (Clinical Data Management, Statistics, and Medical Writing services) which extend from staffing to scalable FSP models. Consulting

5 Ahmedabad India 511, Safal Prelude, B/s Riveria Antilla, Opp. Prahladnagar Garden Cross Road, Corporate Road, Prahladnagar Ahmedabad, Gujarat India. Telephone : +91(079) info@clinnex.com