Services

Clinical Data Management

As a part of data management services, EUPRAXIA’s portfolio of service offerings is providing or suggesting end-to-end data management solutions to our esteemed client. We believe in providing customized solutions to varying needs of client; be it from designing paper or eCRF and take it to its logical conclusion for Database Lock (DBL).

Our services

  • Gap analysis of current practices versus what should be the right practice from CDISC/SEND perspective
  • eCRF and paper-based CRF design as per CDASH standards of CDISC
  • SOP changes, redesigning, companywide training of new processes/changes
  • Database Design and Programming
  • Edit check programming, validation, and testing
  • Data management plan development
  • CRF completion guidelines
  • Data entry and processing (First Pass, Second Pass)
  • Data cleaning and validation
  • Medical coding
  • Integration of external data
  • SAE reconciliations
  • Data Export
  • Database Lock and Archival

Biostatistics and Programming

As a part of Biostatistical services, EUPRAXIA’s portfolio of offering service is to provide / suggest end-to-end Biostatistical solutions to our esteemed client. We provide support and solution right from inputs to protocol, SAP writing, sample size calculation, randomization till the analysis report writing, ad-hoc analysis and much more. With the client we engage ourselves at the project inception level.

We offer

  • Statistical Inputs in Protocol
  • Sample size computation / validation
  • Randomization generation
  • Statistical Analysis Plan (SAP)
  • Tables, Listings & Figures (TFLs)
  • CDISC complete support
  • Statistical Analysis Report (SAR)
  • Ad-hoc Analysis
  • Legacy Studies / Complex Studies / CDISC Conversion
  • ISS / ISE Analysis

CDISC (SDTM & ADaM)

EUPRAXIA adheres and firmly support to the principle mentioned by CDISC, “CDISC Data Standards streamline clinical research and enable connections to healthcare, empowering the valuable information offered by patients participating in research studies around the world.”

We Offer

CDISC Package Creation Services

  • Creation of Annotated CRF
  • Creation of SDTM datasets
  • Creation of ADaM datasets
  • Creation of SDRG
  • Creation of ADRG
  • Creation of Define.XML

CDISC Package Review Services

  • Review of Annotated CRF
  • Review of SDTM datasets
  • Review of ADaM datasets
  • Review of SDRG
  • Review of ADRG
  • Review of Define.XML

CDISC (SEND)

Eupraxia takes pride in pioneering the CDISC/SEND standards in a customized way in Indian Big Pharma companies. (See Case Study 01 and Case Study 02).

Eupraxia undertakes Acute Toxicity, Repeat Dose Toxicity Studies, Safety Pharmacology Studies as well as bigger volume studies such as carcinogenicity studies. We provide services at three levels 1. Data Entry and Data Discrepancy identification for interrelated data sets, 2. SEND data sets / package creation and 3. Use SEND data files for the statistical analysis of toxicological data using SAS programming language. Note that Eupraxia does not derive any statistical data analysis from raw data; it uses only SEND data files for any analysis, keeping raw data untouched once transformed to any of the CDISC model.

Medical Affairs

EUPRAXIA offer Medical Affairs services including

  • Development of Protocol & Attachments
  • Manuscript writing & Publication
  • Case Study Report Designing
  • ICF designing
  • IB preparation
  • Product Monograph Creation
  • Adverse Drug Reaction Booklet Creation
  • Lay Summaries
  • Labelling

Quality Assurance

Pharmaceutical industry is regulation driven and Eupraxia is committed to adhere to the global standards. Eupraxia has a dedicated and independent Quality Assurance unit. Our quality assurance team is meticulously detail-oriented and updated about the changing regulatory requirements. Our processes and procedures are built from the ground, and follows the “First Time Right” principle.

Our quality team helps us with

  • Develop and maintain ICH GCP compliance standard operating procedures
  • Staff training
  • Internal Audits
  • Identifying non-conformances and provide suitable recommendations
  • Conduct share best practices sessions
  • Oversees documentation, reporting, and closure of audit findings (internal and external)
  • Any-time, “Audit-readiness”

Information Technology

The combination of regulatory IT compliance complexity and constant change is a challenge for pharmaceutical organizations that needs constant focus to find innovative solutions. As an enabling function, IT compliance at pharma, healthcare and research organizations covers multiple areas, including various departments, electronic data processing, automation, backup, archiving and many more. Observing regulatory security and compliance to policies are vital for every organization. Eupraxia has a well experienced team members for IT compliance and support. Our IT team is meticulous about the changing compliance landscape and electronic data integrity requirements. Eupraxia offers following IT services.

IT Services

  • Computer System Validation
  • IT Compliance Training
  • Risk Management
  • IT Audit & Advisory
  • Data Automation
  • IT Infrastructure