What We Do
Our Services
Comprehensive clinical research solutions covering every phase of your trial — from initial site selection through final reporting.
What We Offer
7 specialized services covering the full spectrum of clinical research needs.
Site Selection and Feasibility
Comprehensive evaluation of investigator sites to identify the optimal locations for successful clinical trial execution.
- Evaluation of eligible patient numbers per site
- Assessment of site staff experience and ICH-GCP training compliance
- Review of trial facilities, equipment, and infrastructure
- Assessment of investigator interest and commitment
- Analysis of previous site experience and recruitment history
- Evaluation against additional sponsor-specific requirements
Clinical and Observational Trial Management
End-to-end management of Phase II–IV clinical and observational research projects across all therapeutic areas.
- Site Qualification Visit (SQV) — evaluating site suitability before trial start
- Site Initiation Visit (SIV) — training and setting up the site for trial conduct
- Site Monitoring Visit (SMV) — ongoing oversight during the trial
- Site Close-Out Visit (SCOV) — formal trial closure and reconciliation
- Study drug and investigational materials management
- Investigator contract negotiation and management
- Trial Master File (TMF) preparation and maintenance
- Project management and vendor coordination
Regulatory Affairs
Expert handling of all regulatory submissions and compliance requirements from Ministry of Health to Local Ethics Committees.
- Preparation and submission of applications to regulatory authorities (MoH) and Local Ethics Committees (LECs)
- Investigational product (IP) import and export license management
- Amendment submissions and regulatory notifications
- Safety reporting (IND safety reports, SUSAR notifications)
- Annual reporting and final report notifications
- Contract negotiation with regulatory bodies
- Investigational product destruction permission management
Medical Writing
Professional clinical documentation produced in collaboration with investigators and scientists across all therapeutic areas.
- Protocol writing and scientific development
- Final Study Report (FSR) preparation
- Case Report Form (CRF) design and development
- Informed Consent Form (ICF) design
- Statistical analysis planning and activities
- Documentation and abstracts for congress exhibits and publications
Site Coordinator Services
Dedicated on-site coordinators supporting investigator sites with day-to-day trial operations and patient management.
- Patient recruitment support and screening coordination
- Informed consent procedure assistance
- Trial Master File (TMF) tracking and maintenance
- Source documentation and data entry accuracy checks
- Case Report Form (CRF) completion and query follow-up
- Laboratory sample management and logistics
- Investigational product accountability and temperature monitoring
- Preparation for monitoring visits and regulatory audits
Medical Translation
Precise, on-time medical translation services delivered by a physician-led team with deep clinical expertise.
- Summary of Product Characteristics (SmPC) translation
- Patient Information Leaflets (PIL) translation
- Product labelling and packaging text translation
- Informed Consent Form (ICF) translation and back-translation
- Clinical trial protocol translation
- Case Report Form (CRF) translation
- Investigator Brochure (IB) translation
- Scientific articles and technical documents
Investigator Meeting Organization
Full-service planning and execution of investigator kick-off meetings, including logistics, travel, and presentations.
- Participant invitation management and confirmation tracking
- Study material preparation and distribution
- Travel arrangement assistance for investigators and staff
- Venue selection and on-site service coordination
- Team training sessions and presentation support
- Translation and interpreting services during meetings
- Administrative support throughout the event lifecycle
Need a custom service package?
Our team can design flexible, cost-effective solutions tailored to the specific requirements of your clinical research project.
Discuss Your Project