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Services

Insourcing & Outsourcing

Staffing Services on Programs Basis

Full-Time and Part-Time Staffing

Experienced Staff with Great Integration

Regulatory Affairs Management

Full Awareness of Local Requirements
Continuous Update of Regulatory SOPs
Full Files Preparation and Submission
Ad-Hoc Activities and Safety
Management

Biostatistics

Sample Size Calculation, Statistical Analysis,
TLFs Generation

Project Management

Experienced Project Managers
Management of Plans, Budget,
Resources, Allocation, Risk
Management, Reporting, Analysis,
CAPA, etc.

Data-Management & e-Solutions

Data Plans Generation, CRF and e-CRF Data Collection,
Data Entry and Queries Resolution, Database
Management and Clinical Coding, e-Solutions.

On-Site and Remote Monitoring

Experienced Study Monitoring
Experienced CRAs by Therapeutic Area
Good Relations with all Stakeholders
Well-Trained Staff with Continuous
Learning Programs.

Medical Writing

Advisory Boards Coverage, Clinical
Regulatory Writing, Medical
Communication, Publication Writing,
Manuscript Writing and Submission,
Posters and Educational Materials
Writing.

Pharmacovigilance and Safety

Literature Screening, QPPV and Deputy QPPV Assignment, ICSR Reporting & Follow-Up, QMS Design

AEs / SAEs Management.

Health Economics

Pharmacoeconomics for the Decision Makers Budget Impact Analysis, Cost-effectiveness Studies.

Clinical Study Coordination

Qualified CRCs Support, Patient Screening
and Enrollment, Data Entry Management
and Queries Resolution, Maintenance &
Update of the Study Files.

Trainings and Workshops

Tailored Programs for HCPs, Pharma, etc., GxP Workshops,
Medical Writing, Biostatistics Regulatory, PV and
Pharmacoeconomics.

Patients Support and Adherence Programs

Nursing and Home Care Services,
Compliance and Adherence
Management.

Market Research

Problem identification, Market research design, Sample size calculation , Data collection , Statistical data analysis, Final report findings & conclusion.

Publication Writing

Literature Screening, QPPV and Deputy
QPPV Assignment, ICSR Reporting &
Follow-Up, QMS Design, AEs / SAEs
Management.

Market Access

Preparing and submitting dossier, providing guidance on regulatory requirements, market penetration recommendations.