Valnizens

Biostatistics and Medical writing

Clinical Study Design
Protocol Development
Randomization Schedule and SAP development
Data Interpretation
Clinical Study Report
Publication Writing

Clinical Data management

e-CRF designing
Database development and programming
Database user training
Data management plan
Centralized data monitoring plan
Data entry
Data review and cleaning
Query Resolving
Database Locking

Project Management

Site and Investigator selection
Contract and Budget Negotiation
Informed Consent process
Site Initiation
IRB/IEC coordination
Subject Recruitment and Coordination
Maintenance of Site master files
Monitoring and Auditing
Study Closeout
Audit Preparation

Allied Services

Industrial and mechanical designing
Functional prototyping
Precompliance testing
Preclinical services
Clinical research and development
Regulatory affairs and market authorization
Commercial strategy and market access

Medical Devices

International/Local Medical device regulatory consultation
MedTech Roadmap: From patent to the market (EU MDR/FDA).
CE Marking, Quality Management System (ISO 13485 & ISO 9001), Market Strategies, Design Dossier Preparation, Risk Management, Medical Device Testing.
Regulatory Strategy (CE Mark, IDEs, 510(k)s, De Novo, PMA, HDE Strategy
Technical File Development and Compilation for Class I, II, and III.
UDI consulting
ISO 14971 risk management consulting for medical device companies.
Post Market Clinical Follow Up (PMCF).

In Vitro Diagnostic

International/Local In Vitro Diagnostic regulatory consultation
IVD Roadmap: From patent to the market (EU IVDR/FDA).
Technical File Development and Compilation for Class A, B, C, and D Devices
UDI consulting.
ISO 14971 risk management consulting for in-vitro diagnostics companies.
Post Market Performance Follow Up (PMPF).