Clinical Research Services (CRO) - ClinVice

Clinical Research Services (CRO)

We Offer CRO Services

At "ClinVie" Clinical Research Services

Your Trusted Clinical Research Partner in The MENA Region

Clinical Research Services (CRO)

Regulatory & Start-Up

Regulatory submissions to local authorities/HAs (e.g., MOH, IRBs/ECs)
Feasibility studies and site selection
Preparation of ICFs and translated documents
Study start-up planning and timelines
Import/export license management

Clinical Trial Monitoring & Management

Site monitoring (on-site and remote)
Site management and oversight
Risk-based monitoring (RBM)
Patient recruitment support
Site issue escalation and resolution

Project Management

Dedicated project managers
Study timeline and milestone tracking
Budget oversight and coordination
Vendor coordination (e.g., labs, EDC, central imaging)

Data Management & Biostatistics

eCRF design and implementation
Data cleaning and query resolution
SAE reconciliation
Statistical analysis plan (SAP) development
Statistical programming
Data listings, tables, and figures (TLFs)

Medical Writing

Clinical Study Protocol (CSP) and amendment writing
Investigator Brochure (IB)
Informed Consent Forms (ICFs)
Clinical Study Reports (CSRs)
Manuscripts and other regulatory documents

Quality Assurance (QA)

Internal audits and SOPs
GCP compliance checks
Site audit preparation
Sponsor and regulatory inspection readiness

Pharmacovigilance & Safety Reporting

SAE reporting to regulatory bodies and sponsors
Narrative writing and MedDRA coding
DSUR and SUSAR coordination
Safety database management

Your Regional CRO Partner from Startup to Submission

Our Flexible CRO Solutions Help Sponsors Navigate Regional Regulations and Execute Clinical Research with Speed and Quality.

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