Clinical Trial Delivery

As clinical trials become increasingly complex, sponsors need a partner that can seamlessly connect operational execution, technology, and patient safety oversight. SDC provides specialized support services that help sponsors successfully implement, manage, and optimize critical clinical trial technologies and operational workflows. Our experienced teams deliver study start-up support, RTSM/IRT services, safety management services, clinical data operations, and technology project management across the clinical trial lifecycle.

By combining deep clinical expertise with AI-enabled technology solutions, we help sponsors execute studies efficiently while maintaining the highest standards of quality and accuracy.

Effective trial oversight requires timely access to operational, clinical, safety, and data quality information. SDC helps sponsors establish risk-based oversight strategies that improve visibility into study performance, support proactive decision-making, and enable targeted intervention throughout the clinical trial lifecycle.

By leveraging centralized review processes, cross-system integration, and operational analytics, we help sponsor teams focus attention where it matters most.

Risk-Based Monitoring & Centralized Review

SDC designs data-driven oversight strategies that focus monitoring where it matters most, using centralized review, integrated study data, and predefined risk indicators to identify emerging risks earlier and support informed decisions.

Key focus areas include:

Risk-Based Monitoring (RBM) strategy development
KRI & KQI definition
Risk threshold design and review
Centralized data review methodology
Cross-functional risk review meetings
Escalation and mitigation frameworks

Clinical Trial Oversight Services

Our experienced clinical trial operations teams deliver comprehensive support across all phases of clinical development, including:

Centralized data review
Cross-system data integration
Study risk assessments
Operational performance analytics
Historical site performance analytics
Protocol compliance monitoring
Data quality surveillance
Risk monitoring & trending
Oversight reporting & dashboards
Trial oversight consulting

RTSM Services include:

IRT strategy and consulting
Requirements development and review
System implementation support
User acceptance testing (UAT) and validation coordination
IRT project management across startup, conduct, and closeout
Clinical supply management and resupply strategy support
User, site, and study-team training
Change management and system revision coordination
Audit and regulatory-request support
Study closeout and eTMF transfer support

Supported IRT and RTSM Platforms

SDC supports multiple industry-leading IRT/RTSM solutions, including:

*When using these platforms, SDC performs all IRT development services internally, providing complete project management and oversight from study startup through closeout.

Learn more about our IRT/RTSM technology here →

Effective safety oversight requires both robust processes and flexible technology. SDC provides comprehensive Safety Management and Pharmacovigilance services that help sponsors establish efficient, compliant, and scalable safety operations throughout the clinical trial lifecycle.

By combining experienced safety professionals, proven workflows, integrated eSAE in EDC capabilities, and flexible technology solutions such as SafetyEasy®, SDC helps sponsors improve visibility, streamline safety processes, and maintain confidence in study oversight from startup through closeout.

Safety Management Services

Safety management planning
SAE processing & follow-up
Medical review coordination
Safety reporting & communications
SUSAR notifications
Pharmacovigilance support
Safety oversight & governance
Safety review meetings
Safety system training & support

Why Sponsors Choose SDC for Safety Management

Streamlined safety workflows
Reduced manual data entry
Enhanced reporting accuracy
Faster communication of critical safety events
Improved visibility for study safety teams
Integrated technology that supports efficient oversight and compliance

CLINICAL TRIAL DELIVERY

Empowering Better Clinical Trial Delivery