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DATA COMPUTING & RWE

Unlock the power of data with EuroPharMedTech's computing solutions, transforming complex information into actionable insights for the pharmaceutical industry.

SERVICES​​​​​

1. Data management

  • ​​​​​Data Management Plan (DMP), Data Validation Plan (DVP)

  • Database design

  • Development of EDC tools (customized web-based tools and surveys)

  • Annotated CRF

  • Data collection, CRF tracking

  • Data entry, data cleaning, data aggregation, data exports

  • Users management

  • Training and user support

  • Discrepancy management

  • Medical coding

  • Database locking

  • Hosting

2. Software development & Testing

  • Web Solutions

  • Desktop and Server Solution

  • Mobile Solutions

  • Validation & Software Testing

3. QA/QC & Validation

TherAxess’ consultants and partners have been involved in various IT systems implementation and software validation for the pharmaceutical and non-pharmaceutical industry.

 

We combine the extensive knowledge of risk-based validation approach and the best practices in the pharmaceutical or non-pharmaceutical.

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  • QMS definition – preparation of SOPs, FORMs, GUIs

  • Computerized system validation

  • IT infrastructure qualification

  • Project management

  • Change management

  • Supplier assessment

4. Real World Evidence

At EuroPharMedTech, we provide tailored Real-World Evidence (RWE) solutions to support pharmaceutical companies, biotech firms, and healthcare organizations in leveraging real-world data (RWD) for regulatory compliance, market access, and clinical decision-making.

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1. Regulatory-Grade RWE Generation

  • Support for regulatory submissions to agencies like the EMA, FDA, and HTA bodies

  • Assistance in meeting compliance with evolving RWE regulatory frameworks

  • Post-marketing safety and effectiveness studies (PASS & PAES)

 

2. Study Design & RWE Methodology

  • Observational study design (retrospective & prospective)

  • Comparative effectiveness research

  • Synthetic control arms to supplement clinical trials

 

3. Data Analytics & Advanced Insights

  • Real-world data curation & standardization

  • AI-driven RWE analytics to extract meaningful insights

  • Evidence synthesis for market access and reimbursement

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4. Market Access & Health Technology Assessment (HTA) Support

  • HTA dossier preparation with real-world insights

  • Cost-effectiveness & budget impact modeling

  • RWE-driven payer engagement strategies

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5. RWE Strategy & Consulting

  • Gap analysis to identify RWE opportunities

  • Study protocol development aligned with regulatory expectations

  • End-to-end project management for RWE initiatives

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