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Our services
A full service regional Contract Research Organization.
Insourcing & Outsourcing
Staffing Services on Programs Basis.
Full-Time and Part-Time Staffing.
Experienced Staff with Great Integration.
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Regulatory Affairs Management
Full Awareness of Local Requirements Continuous Update of Regulatory SOPs
Full Files Preparation and Submission Ad-Hoc Activities and Safety Management.
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Medical Writing
Advisory Boards Coverage, Clinical Regulatory Writing, Medical Communication, Publication Writing, Manuscript Writing and Submission, Posters and Educational Materials Writing.
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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.
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Project Management
Experienced Project Managers Management of Plans, Budget, Resources, Allocation, Risk Management, Reporting, Analysis, CAPA, etc.
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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.
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Pharmacovigilance And Safety
Literature Screening, QPPV and Deputy QPPV Assignment, ICSR Reporting & Follow-Up, QMS Design AEs / SAEs Management.
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Clinical Study Coordination
Qualified CRCs Support, Patient Screening and Enrollment, Data Entry Management and Queries Resolution, Maintenance & Update of the Study Files.
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Trainings And Workshops
Tailored Programs for HCPs, Pharma, etc., GxP Workshops, Medical Writing, Biostatistics Regulatory, PV and Pharmacoeconomics.
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Market Research
Problem identification, Market research design, Sample size calculation , Data collection , Statistical data analysis, Final report findings & conclusion.
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Publication Writing
Literature Screening, QPPV and Deputy QPPV Assignment, ICSR Reporting & Follow-Up, QMS Design, AEs / SAEs Management.
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Market Access
Preparing and submitting dossier, providing guidance on regulatory requirements, market penetration recommendations.
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Health Economics
Pharmacoeconomics for the Decision Makers Budget Impact Analysis, Cost-effectiveness Studies.
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Biostatistics
Sample Size Calculation, Statistical Analysis,
TLFs Generation.
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Patients Support And Adherence Programs
Nursing and Home Care Services, Compliance and Adherence Management.
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