Roxaane Research
Join $20 billion Global Clinical Research Industry
We are currently recruiting candidates for our Clinical Research, Pharmacovigilance and Clinical Data Management Operations.
Interested candidates are invited for a walk in interview at our office address mentioned below between 10am- 4pm between Monday - Friday.
Clinical
Research
Organisation
IT ENABLED SERVICES
ABOUT US
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EXPERTISE
About Us
Name of the Company : Roxaane Research
URL : www.roxaane.com
Company Evolution : Private Limited Company
Corporate Identity Number : U73100TN2007PTC06431
Nature of the Business : Clinical Research Services and CDM
Clinical Trial Management, Drug Development Support Services, Data Management and Biostatistics Services.
Roxaane Motto : "Ensuring Quality in every sphere of Activity"
Roxaane Vision: "Improving Healthcare for All through Scientific Research
with Ethics"
Roxaane Mission : "To become a global leader in Clinical Research through
unsurpassed Quality, Efficiency, Innovation and Speed"
Roxaane Quality Policy
"Roxaane Research Private Limited” is committed to serve the Pharmaceutical and
Biotechnology Industries by exceeding their expectations and continually improve
the effectiveness of the Quality Management System with high quality standards
on par with International Regulatory requirements"
Clinical Operation
The Clinical Operations group comprises of Clinical Research Associates, Clinical Trial Assistants and Project Managers. The core responsibility of this group is to monitor sites to ensure collection of clinical data that is ICH GCP, Protocol and any other applicable guideline compliant
Roxaane Services Include:
Preclinical / Phase I
The clinical pharmacology team at Roxaane Development Solutions has extensive experience in the design, implementation and interpretation of clinical pharmacology studies in all major therapeutic areas.
Once the correct study design has been agreed there is rapid transfer and start up of the clinical phase. Roxaane undertakes First in Man (FIM) studies.
ROXAANE has experience implementing:
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Roxaane’s Phase I services include:
Phase II-IIIb
Roxaane specialises in the planning management, execution, and analysis of Phase II-IIIb clinical trials, ranging from small studies to complex, multinational projects.
Roxaane provides customised services, which can be deployed on a stand alone basis or as part of an integrated “full-service” solution. These services can support both global and locally managed projects.
Pharmacovigilance
Different countries and regions witness varied patterns in drug effects and reactions. This occurs due to differences in diseases, genetics, diet, prescribing practice, local traditions and drug manufacturing process impacting its quality, amongst others. Pharmacovigilance is practised to ensure the quality of medicines is maintained and to safeguard public interest to prevent any harm to patients.
Hence through pharmacovigilance we are able to improve patient care, safety and public health, whilst ensuring a rational and effective use of medicines and therefore also providing cost benefits through use of the medicines. In addition, through this process we are able to encourage better understanding and clinical training, and educate the public on key aspects in medicine.
We undertake periodic safety update reports, prepare literature reviews and medical narratives, conduct CIOMS on the web, regular medical monitoring and undertake ongoing signal detection as well as trend analysis. Broadly categorised, our services encompass safety management, regulatory reporting, and post-marketing surveillance, as well as technology support.
Roxaane provides highly responsive, multi-lingual, customised pharmacovigilance services, from small studies to complex, multinational projects. These can be deployed on a standalone basis or as part of an integrated “full service” solution.
Medical Affairs
Rigorous medical oversight during development optimises your product’s chances of making it to market.
Roxaane Medical Affairs experience covers all aspects and phases of product development, creating therapeutic development programs, designing individual clinical protocols, providing expert medical monitoring of clinical trials, as well as reviewing final study reports and publications. Our unified team approach ensures we will meet, and exceed, your product development objectives.
Drug Safety
Roxaane ’s Drug Safety Department supports your product’s development by implementing efficient processes, compiling a concise safety profile of your product, and developing a comprehensive risk management plan to get you safely through the approval process.
Once your product is on the market, Roxaane supports your product with proactive monitoring of the safety profile through ongoing surveillance, signal detection and analysis, and adherence to a pre-planned risk management strategy.
A full-spectrum of services includes:
Pharmacovigilance planning and auditing
Clinical Data Management
Affordable, Quality Clinical Data Management Services
Data Management & Reporting
Study Start-up
• Detailed file specifications
• Programming standards and validation lifecycle
• Rigorous test transfer and approval process
Flexible File Structure and Parameters
• Standard data files (CDISC) or customized data files
• Cumulative or incremental
• Transmission for CDMS, IVR, Safety Board, etc.
Study Maintenance
• Customized protocol-specific edit checks prior to data transmission
• Proactive edit checks upon sample reception
• Data reconciliation and integrity checks following data extraction
Study Close-out
• "Clean as you go" processes reduce last-minute changes
• Flexible schedules and data send frequencies
Database Set-up
CRF Design, Printing & Distribution
Roxaane’s Data Management team has standard library of CRF modules (in paper and EDC) and also has vast experience of implementing client standards, integrating questionnaires and diary cards. Roxaane provide medical and statistical review of CRF versus protocol to ensure primary and efficacy variables are captured. Roxaane has experience of providing sponsor-specific printing requirements, worldwide delivery and bespoke distribution methods.
Roxaane designed over 250 CRFs for clients across all phases and therapeutic areas.
Data processing / delivery
CRF Imaging and Workflow
• 24 hour data entry
• Access to CRF images from all global locations
• Client access to scanned CRFs and queries
• Split-screen data entry
Coding
• In-house developed tool
• Use of integrated coding tools
• MedDRA E & J
• WhoDrug E & J
• ATC coding by indication
• Expertise with coding on sponsor specific tools
SAE Reconciliation
• Automatic routing of AEs to Medical group in paper and EDC systems
• Email alerts in RAVE and InForm
Integration of Third Party Data
• EDC
• Central laboratories
• Local laboratories
• PK
• ECG
• IVR
• ePRO
• Imaging
Biostatistics
Main Service Offerings
Medical Writing
The Medical Writer is Closely Involved with the Following:
Study Protocol
This includes biometric study planning and sample size calculation. All protocols are written according to ICH GCP, national laws and indication specific guidelines.
Case Record Form
CRFs have been delivered to all continents - reliably, on time and precise in wording,mono-, bi-, or multilingual and designed for a complete data recording according to ICH GCP guidelines.
In addition, Oracle - based electronic CRF is available in CRF layout for studies which run with paper CRFs and RDE in parallel.
Reporting
At Roxaane, clients are provided with in-depth and clear medical reports and integrated reports according to ICH- GCP guidelines.
Medical Writing Services
Roxaane ensures that the medical writer assigned to each project team has the required document and therapeutic expertise to fulfill each sponsor’s needs, including:
Medical Communications
In addition to the above, our medical writing team also provides support with:
Patient Diaries
The advantage of electronic patient diaries has resulted in the decreased use of paper diaries due to their unreliability with errors and speed of data collected. As an option, Roxaane offers our customers the possibility to use Electronic Patient Reported Outcomes Diary solutions (ePRO) which will improve data quality and patient compliance and shorten the time of clinical trials.
The ePRO solutions available include:
Functional Outsourcing
We provide a team of medical and scientific writers, SAS programmers, medical coders and related professionals dedicated to a sponsor who want high quality service customized and delivered in a secure environment from India where such talent with domain knowledge is available at competitive cost.
Bioequivalence Studies
Our Bioavailability and Bioequivalence facility includes, highly sensitive and robust LC-MS/MS and analytical instruments, adequate sample storage facility, greater accountability and traceability for drugs, subdued light - handling of photosensitive molecules, uninterrupted utilities and good backup for contingency.
Our end-to-end service offering comprises regulatory consulting, IP import and sample export, protocol design, ethics committee submissions, safety screening, and bio analytical testing. In addition, we have proven expertise in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using WinNonlin, statistical analysis using SAS, and report writing, amongst others.
We provide Bioanalytical services from discovery through Phase IV, we have growing list of proprietary and non proprietary methods.
We support,
The studies include:
BABE facility.pdf.pdf
Clinical Pharmacology Unit
BABE and intensive PK/PD studies are conducted in our 52 bed Clinical Pharmacological Unit (CPU) equipped with an advanced ICU to handle emergencies, centrally air-conditioned with dedicated areas for screening, counselling, phlebotomy, access-controlled pharmacy, and recreation & dining rooms with state-of-the-art monitoring.
The ICU beds are equipped with defibrillators, ventilators, cardiac monitors, oxygen supply, a crash cart and all emergency medicines. All our facilities are designed to meet high standards of volunteer safety and comply with DCGI specifications.
Bioanalytical
Roxaane Development Solutions partners with each of its clients to provide the bioanalytical services required across all phases of development for both small and large molecules.
Roxaane’s method development teams have extensive experience developing and validating robust bioanalytical methods in blood, urine and tissue specimens to support pre-clinical and Phase I through Phase IV clinical trials with an average method development/validation time of two weeks.
The bioanalytical services group of Roxaane Development Solutions offers method development, assay validation, and specimen analysis using state-of-the-art mass spectrometry (LC/MS/MS).
Validations of bioanalytical methods are performed in compliance with GLP and are patterned after the current FDA "Guidance for Industry - Bioanalytical Method Validation." With a standard-setting run repeat rate of less than 5%, Roxaane able to generate timely and reliable results.
• Strong scientific and regulatory knowledge personnel
• Highly sensitive and robust LC-MS/MS and analytical instruments
• Adequate sample storage facility
• Greater accountability and traceability for Drugs
• Subdued light - handling of photosensitive molecules
• Uninterrupted utilities and good backup for contingency
• Bioanalytical services from discovery through Phase IV
• Growing list of proprietary and non proprietary methods
• Timely, accurate communication and short project time lines
• Ambitious and accepting challenges
Module 1 : Basics
• What is Medical Coding?
• What is Medical Billing?
• Revenue Cycle Management
• CMS-1500 ,claim Form Examples and Explanation
• Clean Claims with examples
• Medical Record
Module 2
• Medical Terminology
• Word root
• Combining forms
• Suffixes
• Prefixes
• Common terms
Module 3
• Anatomy and Physiology with Illustrations
• Integumentary system
• Digestive System
• Respiratory system
• Excertory System
• Musculoskeletal System
• Nervous System
• Cardiovascular system
• Eye
• Lymph/immune system
• Male Reproductive system
• Female Reproductive system
• Oncology
• Pathology
• Pharmacology
• Surgical terms
• Final test for Grading
Module 4
• ICD basics ( Diagnosis Coding)
• Why ICD
• Structure, Volumes
• Classification
• Coding Conventions
• How to Code, Coding examples
• V Codes, V codes examples
• Coding Signs and Symptoms
• E Codes ( External cause)
• Hypertension
• Burns
• Injuries
• Fractures
• Adverse effects/Poisoning
• Cancer ICD Coding, Examples
• Surgical Terms
Module 5
• CPT Basics ( Procedure Coding)
• CPT and HCPCS Basics ( Supplies and Drugs Coding)
• How to Code, Examples
• Examples
• Advanced CPT Coding, Sample Medical Records for coding and billing.
Module 6
• Evaluation and Management Coding ( Office Visits, Consultations,Hospital Visits, Emergency room visits, Critical care services etc)
• Sample Medical Records for coding.
Module 7
• Anesthesia Coding and Billing
Module 8
• Surgical Modifiers, Examples and Practice Questions
Module 9
• Integumentary system Coding
• Incision and Drainage, Skin repair, Paring of lesions, Skin grafting. Coding Mohs Surgery,
• Coding Burns, Coding procedures on nails. Sample questions and answers
• Debridement
• Excision of Lesions
• Suturing ( Repair)
• Procedures Related to Breast
Module 10
• Musculoskeletal System Coding
• Exploration
• Trigger Point Injections
• Arthroscopy
• Spinal instrumentation
• Application of Casts and Splints
Module 11
• Respiratory and Cardiovascular Coding
• Laryngoscopy, Bronchoscopy etc
• Bypass surgery
• Intenrventional cardiology
• Pacemakers
• Procedures related to Lungs
Module 12
• Digestive System Coding
• Esophagoscopy
• EGD
• ERCP
• Liver Procedures
• Sigmoidoscopy
• Colonoscopy
• Tonsillectomy and Adenoidectomy
Module 13
• Urology/OB Gyn Coding
• Module 14
• Neurology Coding
Module 15
• Sense Organs
Module 16
• Radiology Coding
Module 17
• Pathology Coding
Module 18
• Medicine Coding
Module 19
• Practice Questions
Module 20
• Category II and Category III codes
Module 21
• CPT Appendix Examples
Module 22
• HCPCS Examples (Coding Supplies and Drugs)
Module 23
• Medical Billing in detail
• Insurance [ Medicare, Medicaid, TRICARE, Private payers, Workers
Compensation]
• CMS-1500, UB 92
• Denial Management
• Insurance Verification
• Authorizations, CMS 1500 claim form practice.
Sample Medical Records for billing practice. Medical Billing Videos.
• Appeals
• NPI/CLIA
• HMO/PPO/POS plans etc
• PQRI
• DRGs
• APC
Module 24
• HIPAA Titles
• HITECH law
• Stark law
The course consists of the following modules :
PART-I (Core)
BASE SAS
• Introduction To Sas System & Architecture
• History And Various Modules
• Features
• Variables & Sas Syntax Rules
• Sas Data Sets
• Data Set Options
• Operators
• If – Then Else Statement
• Where Statement
• Creating & Redefining Variables
• Reading Raw Data
• Infile Statement With Options
• Multiple Observations and Multiple Datasets.
• Input Styles
• SAS Functions
• Select Statement
• Do Loops
• Leave and Continue Statements
• Output Statement & Put Statement
• Stop And Error Statements
• Array Statement
• Modifying And Combining Data Sets<
• Updating Master Data Set
• Key Board Macros & Add Abbreviations
• Display Manager Commands
BASE SAS PROCEDURES
• Proc Sort
• Proc Print
• Proc Means
• Proc Freq
• Proc Plot
• Proc Chart
• Proc Compare
• Proc Copy
• Proc Summary
• Proc Append
• Proc Datasets
• Proc Contents
• Proc Delete
• Proc Format
• Proc Printto
SAS/REPORTS
• Frequency Report
• One-Way Frequency Report
• Cross Tabular Frequency Report
• Summary Statistics
• Creating A List Report
• Define Statement
• Order Usage and Group
• Printing Grand Totals
• Rbreak Statement
• Tabulate Procedure
• One-Dimensional Tables
• Two-Dimensional Tables
• Obtaining A Total
• Analysis Variables with options
SAS/ODS
• Creating Rtf File
• Creating Html File
• Creating Pdf File
• Creating Xml File
PART-II (Advanced SAS )
ORACLE-SQL CONCEPTS
• Introduction
• History
• Sql Command Set
• Operators In Sql
• Order By Clause
• Group By Clause
• Having Clause
• Distinct Clause
• Create and Insert
• Deleting,Populating And Updating
SAS/SQL
• Introduction To SAS/SQL
• Features & Uses
• Terminology
• Data Types, Key Words, & Operators
• Functions, Predicates & Functions
• Formatting Output
• Group By Clause, Order By Clause & Having Clause
• Case Expression and Conditional Logic.
• Creating ,Populating & Deleting Tables
• Alter Table Statement
• Renaming A Table & Columns
• Changing Column’s Length
• Joins & Views
SAS/ACCESS
• Import & Export Procedures
• Importing data from Ms-Access & Ms-Excel
• Importing data from Oracle database
• DbLoad Procedure
SAS/GRAPH
• Gchart Procedure
• Vertical, Horizontal, Pie
• Donut
• Group,Subgroups
• Gplot Procedure
• Mutliple Plots & Overlay
• Symbol Statement
• Title and Footnote Statements
• Goptions
SAS/MACROS
• Macro Concepts
• Macros And Macro Variables
• Creating Macro Variables
• Using Macro Variables
• Creating Modular Code With Macros
• Invoking A Macro
• Adding Parameters To Macros
• Macros With Conditional Logic
• Using Various Procedures In Macros
• Automatic Variables
• Macro Functions
• Including External Macros
SAS/STAT
• Proc Univariate
• Proc Corr
• Proc Reg
• Proc Anova
• Proc Rank
• Proc Transpose
SAS/WAREHOUSE ADMINISTRATOR 3.5
• Introduction To DW
• Relationship Between SAS And Data Warehousing
• Database Designing
• Types Of Schema
• Global Warehouse Designing Steps
SAS/ETL
• Introduction To ETL
• Application Of ETL In DW
• ETL Process Model Development In SAS With Project
PART-III Project
• CLINICAL PROJECT
Information technology
Description of Data Management Software
