Nature Network - Recent topics from BIO OPPORTUNITIES The most recent forum topics from BIO OPPORTUNITIES http://network.nature.com/forum/G775CFCAA en-us 40 A new CRO ready to take up challenging biostatistics and CDM projects (0 replies) It is a pleasure to inform you that Roxaane Research Limited, a full service Clinical Research Organization, located at Ascendas International Tech Park, Chennai, India, has commenced full-fledged Operations catering to the Pharmaceutical, Medical Devices and Biotechnology industry. It has an extensive network operating from all major Indian cities and also has its presence in US.
Roxaane possesses State of – the – Art Clinical Research facilities that meet International and national regulatory requirements. Roxaane is manned by Industry experienced Clinical Research Professionals who are qualified, experienced and Internationally trained. The team consists of several Physicians and Doctorates in Pharmacology along with Graduates in Life Sciences.
Please Click on this link to view our Office and Human Resource http://www.roxaane.com
Roxaane’s infrastructure includes Oracle Clinical Data Management System, MedDRA and WHO-DD for Coding, Crystal Reports for Report Generation, SAS for Biostatistical analysis, SAS – Pheedit for Clinical Data Management, WinNonlin for Pharmacokinetic Analysis. We also provide services for any client specific CDMS on an ASP model.
We offer the following services:
 Clinical Operations
 Clinical Data Management
 Pharmacovigilance
 Medical writing
 Biostatistics
Roxaane’s end-to-end service approach delivers all necessary technical processes, project management and technological add ons for you to conduct compliant and profitable research with strict adherence to time schedule.
We invite you to visit us to explore synergies and long term scientific, profitable and sustainable, business relationship.
Please visit our website www.roxaane.com
Biostatistics
Roxaane Services has a dedicated biostatistics department.
Our team consists of,
o Highly qualified and experienced statistical programmers expertise in Development and validation of SAS® programs covering all steps of a clinical development including the generation and maintenance of integrated databases spanning all clinical trials of a project
o Experience ranges across Phases I-IV, investigator-initiated studies, data monitoring committee support, and meta-analyses.
o Preparation of data for submission to health authorities, e.g. FDA
o Scientific Quality Assurance (QA) team performs periodic review of programming standards (program structure, notation, unit testing and electronic filing of programs) and ensures compliance with corporate and study specific SOPs.
Roxaane Resources includes,
• SAS® 9.1.3 and Windows XP
• Interface to Oracle® Clinical in order to access study data and codelists in SAS® in a standardized and validated manner
• Extensive library of SAS® macros and program modules for standard statistical analysis, including evaluation of laboratory data, adverse events, descriptive and inferential statistics, graphical data display, etc.
• WinNonLin® for pharmacokinetic analyses
• Extensive library of SAS® macros and program modules for standard statistical analysis including evaluation of laboratory data, adverse events, descriptive and inferential statistics, graphical data display, etc.
• Library of program modules for the analysis of pharmacokinetic data
Roxaane’s extensive biostatistics services includes,
• Clinical Study Protocol Development
o Development of study design
o Sample size/power determination
o Formulation of statistical analyses
o Write statistical analysis section of protocols
• Program development plans :
o Program data consistency checks
o Program data listings
o Program tables and graphs
o Convert data to SAS format
o Ad hoc programming
o Program validation in line with regulatory requirements (GCP, ICH, FDA and EMEA guidelines, especially ICH E9, FDA Guidance “General Principles of Software Validation” and “Computerized Systems used in Clinical Trials”) and accepted industry standards
• Randomization schedules created and managed to ensure integrity of treatment masking
• Statistical Analysis
o Merging disparate datasets,
o Creation of analysis datasets and derivation of complex computed variables
o Perform interim and final statistical analysis of clinical study data
o Perform statistical analysis for integrated study reports and study data
o Consult on statistical problems
• Statistical Report Preparation
o Generation of sophisticated and accurate outputs, i.e. tables, figures, listings necessary in clinical study reports, drug submission dossiers or internal decision making
o Generation of customized data displays (e.g. patient profiles, support of external committees such as Data Safety Monitoring Board, publications, etc.) in electronic and paper format

• Preparation of regulatory and CDISC compliant electronic case report form tabulations (eCRTs)
Mr.Ganesh
Manager Business Development
Roxaane Research Limited,
Ascendas International Tech Park, Phase II,
Taramani, Chennai- 600113 INDIA

Ph : +91-44-42912929
Fax : +91-44-42912902
Mobile : +91-9884021310
E-mail : ganesh@roxaane.com; vasu@roxaane.com
Web site: www.roxaane.com

]]> Tue, 29 Jul 2008 09:12:04 -0000 http://network.nature.com/forums/G775CFCAA/2129 Roxaane Research http://network.nature.com/forums/G775CFCAA/2129