Our Services

Full-service CRO across Med Device, Pharma, and Advanced Therapies - Phases I-IV

Service Pillar

Regulatory & Start-Up

We manage the full regulatory pathway to get your study approved and running as fast as possible, handling all local requirements, documentation, and negotiations.

Regulatory operationsSubmissions, translations, notarizations and local documentation
Ethics committee submissionsHelsinki, LEC, NEC and institutional review board filings
Competent authority interactionsMoH, PharmCom and regulatory agency communications
Site contracting & budgetsSponsor-site contract negotiations and budget agreements
IP managementInvestigational product supply chain and accountability
Import/export permitsObtaining permits for investigational products across all countries
Service Pillar

Clinical Operations

Comprehensive operational management from study start-up through close-out, ensuring efficient site performance and patient enrollment across all study sites.

Monitoring visitsOn-site and remote monitoring per ICH-GCP and monitoring plan
Operations manuals & plansDevelopment of study-specific manuals, monitoring plans and guidelines
Project managementTimelines, budgets, resource allocation and milestone tracking
Sites managementSite selection, qualification, initiation and close-out visits
Patient recruitmentEnrollment strategies, feasibility assessments and recruitment tracking
Bio-sample handlingSample collection, processing, shipping and central lab coordination
Home-Based Services
Specially trained teams visiting patients at home to conduct monitoring, ensuring continuity of care, improved compliance and a more comfortable trial experience.
Service Pillar

Quality & Oversight

We ensure your study meets the highest quality standards with rigorous audit preparation and compliance management. Our track record includes multiple successful audits and inspections.

Auditing and inspectionsPreparation, support and follow-up for sponsor, RA and ethics audits
Quality assuranceSOPs, process compliance, CAPA management and quality metrics
Compliance managementICH-GCP, local regulations and sponsor-specific requirements
Risk-based monitoringRisk assessment plans and centralized monitoring strategies
Service Pillar

Data & Technology

End-to-end data management and technology solutions to ensure accurate, high-quality data capture and documentation throughout your trial.

Data managementDatabase design, data entry, cleaning, coding and lock
eTMFElectronic Trial Master File setup, maintenance and inspection-readiness
CRF designCase Report Form development aligned with protocol and statistical plan
EDC programming & managementEDC licensing, build, UAT, deployment and ongoing support
Service Pillar

Medical & Scientific

Our experienced medical team provides ongoing scientific oversight, safety monitoring, and clinical documentation throughout your study.

Medical monitoringOngoing safety review and medical oversight by qualified physicians
PharmacovigilanceAdverse event reporting, safety signal detection and SUSAR management
Medical writingProtocols, clinical study reports, IB updates and regulatory documents
Scientific advisoryProtocol design support and therapeutic area expertise

Need a Full-Service or Flexible CRO Partner?

aCROss Medical is fully scalable - pick only the services you need, or let us run your trial end-to-end. From a single pillar to full study delivery, we adapt to your program.

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