Biometrics
Data Management
- Database Design, Development & Programming
- CRF annotation &Manual Data Handling
- Data Management &Validation Planning
- Dictionary Processing & Medical Coding
- Single & Double Data Entry
- Medical Data Coding by Certified Coders
- Data Quality Review and Data Validation/Cleaning
- Adverse Event Reconciliation
Biostatistics
- Sample Size/Power Determination
- Randomization Schedule
- Statistical Input for Clinical Study Protocols
- Statistical Programming
- Statistical Analysis Plan Preparation
- Statistical Tables, Figures and Listings
- Statistical Analysis Report Preparation
- Creation of CDISC Compliant Databases (e.g. SDTM, ADAM)
Professional Translation Services and Desktop Publishing
- Medical/Pharmaceutical Documentation & Manuals
- Clinical Trials Documentation & Reports
- Journal Articles
- Scientific Materials
- Study Protocols
- Product Brochures
- Training Materials
- Advertising Materials
Regulatory Affairs Services
- Pre-submission Consulting on Regulatory Procedures & Submission Strategy
- Evaluation of Product Submission Dossier
- Dossier Compilation & Submission to Regulatory Authorities for Marketing Authorization
- Post-approval Regulatory Support & Submissions (Variations, Renewals)
- Adaptation & Translation of Product Information (SmPC, labelling & PIL) according to QRD Templates
- Artwork Review
- Other Regulatory Translation Services
- Authorities Interfacing
Pharmacovigilance Services
- Provision of QPPV and 24/7 Safety Contact Person Services
- Registration of Sponsor and of Trial IMPs in Eudravigilance
- Development of CT-specific Supportive Documentation Related to Safety Reporting
- Safety Reporting in Eudravigilance and Submissions to the Authorities
- Preparation and Submission of Development Safety Update Reports
- Pharmacovigilance Training
Resourcing and Recruiting Services to the biopharmaceutical and medical devices industries