Staffing Services on Programs Basis
Full-Time and Part-Time Staffing
Experienced Staff with Great Integration
Full Awareness of Local Requirements
Continuous Update of Regulatory SOPs
Full Files Preparation and Submission
Ad-Hoc Activities and Safety
Sample Size Calculation, Statistical Analysis,
Experienced Project Managers
Management of Plans, Budget,
Resources, Allocation, Risk
Management, Reporting, Analysis,
Data Plans Generation, CRF and e-CRF Data Collection,
Data Entry and Queries Resolution, Database
Management and Clinical Coding, e-Solutions.
Experienced Study Monitoring
Experienced CRAs by Therapeutic Area
Good Relations with all Stakeholders
Well-Trained Staff with Continuous
Advisory Boards Coverage, Clinical
Regulatory Writing, Medical
Communication, Publication Writing,
Manuscript Writing and Submission,
Posters and Educational Materials
Literature Screening, QPPV and Deputy QPPV Assignment, ICSR Reporting & Follow-Up, QMS Design
AEs / SAEs Management.
Pharmacoeconomics for the Decision Makers Budget Impact Analysis, Cost-effectiveness Studies.
Qualified CRCs Support, Patient Screening
and Enrollment, Data Entry Management
and Queries Resolution, Maintenance &
Update of the Study Files.
Tailored Programs for HCPs, Pharma, etc., GxP Workshops,
Medical Writing, Biostatistics Regulatory, PV and
Nursing and Home Care Services,
Compliance and Adherence
Literature Screening, QPPV and Deputy
QPPV Assignment, ICSR Reporting &
Follow-Up, QMS Design, AEs / SAEs
Preparing and submitting dossier, providing guidance on regulatory requirements, market penetration recommendations.