Extended Services

IDMC (Independent Data Monitoring Committee)

Independent Interim Analysis to Ensure Clinical Trial Safety and Efficacy

We objectively assess patient safety and efficacy data

to determine trial continuation or necessary changes.

Key Services

Independent review of cumulative safety and efficacy data
Recommendations on trial continuation or modification
Interim analysis and reporting to regulatory bodies
Third-party unblinded review, if needed

Key Benefits

Early identification of safety risks through interim analysis
Improved trial objectivity and operational integrity
Proactive risk management and regulatory compliance
Alignment with global standards (FDA/EMA)

SRC (Safety Review Committee)

Independent Expert Committee

for Clinical Safety Review

We review safety data to protect patients

and ensure ethical trial conduct,

evaluating both drug effects and patient risks.

Key Services

Independent review of trial safety data
Monitoring of ethical conduct and patient protection
Assessment of drug efficacy and patient risks
Safety reporting and recommendations

Key Benefits

Early detection of safety issues through expert review
Prevention of ethical or patient safety concerns
Establishment of a robust safety evaluation process
Reliable decision-making support based on expert insights

MM (Medical Monitoring)

Ongoing medical monitoring

for clinical trial safety and compliance

We oversee medical issues,

ensuring trial quality and patient safety

through close collaboration with all stakeholders.

Key Services

Medical review and response to adverse events
Review of trial protocols, ICFs, and related documents
Regular medical monitoring throughout the trial
Oversight of protocol deviations and adverse events
Continuous safety reporting to sponsors and regulators

Key Benefits

Early detection and management of medical risks
Prevention of trial delays and safety issues
Comprehensive medical oversight throughout the study
Strong regulatory compliance through expert monitoring

Medical Writing

Expert medical writing for clinical and regulatory needs

We deliver high-quality documents based on scientific evidence, ensuring compliance with GCP and regulatory guidelines throughout the clinical trial process.

Key Services

Clinical Study Reports (CSR), abstracts, scientific posters, and manuscripts
Regulatory submissions (IND, NDA, etc.)
Publications and presentations led by key experts
Support for academic journal submissions and data reporting

Key Benefits

High-quality documents that meet regulatory standards
Effective research communication via publications
Streamlined collaboration across all stakeholders
Faster timelines through expert writing and review

Extended Services

We enhance the efficiency and speed of clinical trials through optimized integrated services.