Our Services
The main services Avidys LLC is offering are as below:
- Vendor Management for Biometrics and Clinical Services
- We can professionally manage your relation with a bigger CRO,
- At a fraction of the cost of a permanent employee.
- Clinical Data Management
- Protocol review, DMP development, DTA/DTP development.
- Case Report Forms (CRF) design and implementation.
- CRF data controls (edit checks) specification and implementation.
- UAT protocols writing and execution.
- Data review and query generation.
- Study reporting (metrics, specific listings).
- Clinical Activities
- Data coding and/or review.
- Coding reports and listings.
- Safety review, ICH E2B(R3) XML generation.
- Safety reports and listings.
- Data visualization (Specific reports, SpotFire, Tableau, Shiny).
- Clinical Programming
- Patient profiles customization.
- SDTM dataset generation.
- Mapping from raw datasets.
- Define.xml/pdf generation.
- User guide writting or review.
- Statistical Programming
- SAP and mock TLFs.
- Statistical report writting and/or review.
- Generation of Tables, Listings, and Figures (TLF).
- ADaM datasets and user guide.
- CDISC SDTM hyper-linked package for submission.
- Data Science
- Post-Hoc analysis.
- Powerpoint presentations.
- Abstracts preparation and/or review.
- Conferences presentation and articles.
- Software Validation
- Software development (requirement, design, coding, testing).
- GAMP validation documentation (system wide and/or study specific).
- Quality Assurance and Training
- Developement and/or Review of SOPs and Work Instructions.
- Training on GCP, ERES, SOPs, and Biometrics.