RISHI  ­BIOTECH 

[ BIO­-IT SERVICES & RESEARCH COMPANY ]

Clinical Data Management services

  • CRF / CDISC compliant Database Design
  • CRF Annotations
  • Study setup and configuration
  • Edit-check specifications and programming
  • Validation procedures
  • Test data entry
  • Double data entry
  • User Acceptance testing and multiple site rollout
  • Discrepancy management
  • AE and SAE reconciliation
  • External data load
  • CDISC ODM compliant data transfers
  • Database Lock and closeout
  • Data extracts
  • Data archival

Bio statistics and SAS Services

  • Power / Sample size estimation
  • Statistical modeling
  • Protocol and SAP preparation
  • Mock tables and listings
  • Edit check programming for Data Management team
  • Data extraction, transformation and loading to SDTM formats
  • Legacy to SDTM Data mapping and conversion services
  • Analysis dataset generation
  • Validation programming and QC
  • Tables, Listings and Graph generation
  • Interim analysis
  • Statistical Analysis
  • Integrated Summary of Safety and Efficacy
  • Final Report generation
  • CRT DDS and Define.xml generation


CDISC and Regulatory services

  • CDISC Strategy, Gap Analysis and Business Case preparation including CDISC compliant tool selection
  • Customized CDISC Training
  • SDTM, CDASH and ODM compliant database design services
  • Data Integration and Data Mapping services for SDTM compliance
  • Customized ODM Gateway services for external data integration
  • Legacy CDM conversion to achieve SDTM compliance
  • SDTM and ADaM compliant dataset preparation
  • CRT DDS and Define.xml (eCTD) preparation
Drug Safety and Pharmaco vigilance services

Data Collection

  • Call center support with 24/7 support
  • Adverse Events and Serious Adverse Events data entry/ logging
Data Management

  • Adverse Events and Serious Adverse Events Tracking
  • Case routing/ processing
  • MedDRA and WHODRL coding
Medical Analysis

  • Adverse Events and Serious Adverse Events analysis
  • Serious Adverse Events narrative writing
  • Medical review and signal detection
  • Literature reviews
Regulatory Reporting

  • Medwatch/ CIOMS form generation
  • Preparation of Periodic Safety Update Reports (PSURs)/ Periodic Adverse Drug Experience Reports (PADERs )
  • Prompt notification of Suspected Unexpected Serious Adverse Reaction (SUSARs)
  • E2B electronic reporting format generation
We support major platforms such as Oracle AERS, ARGUS and ARISg.

Medical coding and Writing

  • Protocol preparation
  • Designing Case Report forms
  • IND/NDA/ANDA preparation
  • Statistical Report Preparation
  • Protocol Authoring Services
  • Investigator's Handbook preparation
  • Informed Consent preparation
  • Standard Operating Procedures preparation
  • Subject Recruitment documents
  • Submission Docket preparation (local and global)
  • Clinical Study Report (CSR) preparation
  • Package Inserts Preparation

Clinical Operations

  • Study conduct as per GCP guidelines on-time and on-budget
  • Site Management
  • SOP preparation
  • Assist in regulatory affairs and approvals
  • Project Management
  • Source Document verification
  • Drug Accountability and Clinical Supplies
  • CRF Data entry and Query Resolution for both EDC and paper based systems


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